Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT04137367
Status:
COMPLETED
Last Update Posted:
2025-02-05
First Post:
2019-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Personalized Approach to Effects of Affective Bias Modification on Symptom Change and Rumination
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D000079562', 'term': 'Rumination Syndrome'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'n.i.landro@psykologi.uio.no', 'phone': '+4795038479', 'title': 'Nils Inge Landrø', 'organization': 'University of Oslo'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months follow-up after intervention', 'description': 'Participant self-report.', 'eventGroups': [{'id': 'EG000', 'title': 'Active Affective Bias Modification', 'description': 'Computer based Affective Bias Modification\n\nAffective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the active condition, the probe appears at the location of the most positive stimuli of each pair in 87 % of trials (encouraging a positive affective bias). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham Affective Bias Modification', 'description': 'Computer based sham Affective Bias Modification\n\nSham Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the sham condition, the probe appears at the location of the most positive stimuli of each pair in 50 % of trials (no contingency between facial expressions shown and the probe location). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Assesment Only', 'description': 'No intervention', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Self-reported Depressive Symptoms: Becks Depression Inventory-II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Affective Bias Modification', 'description': 'Computer based Affective Bias Modification\n\nAffective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the active condition, the probe appears at the location of the most positive stimuli of each pair in 87 % of trials (encouraging a positive affective bias). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.'}, {'id': 'OG001', 'title': 'Sham Affective Bias Modification', 'description': 'Computer based sham Affective Bias Modification\n\nSham Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the sham condition, the probe appears at the location of the most positive stimuli of each pair in 50 % of trials (no contingency between facial expressions shown and the probe location). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.'}, {'id': 'OG002', 'title': 'Assessment Only', 'description': 'No intervention was given, only assessments were conducted.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.1', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '16.5', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '5.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'We estimated a priori that a total of 100 participants would be needed to detect a difference between ABM and sham condition, with a two-tailed α of 0.05 and (1-β) of .80. Power calculation was based on the assumption that 50 % of the participants allocated to ABM would report a minimum of 3 points reduction on BDI-II at six months, compared to 20 % in the sham condition. Assuming 15 % lost to follow up, power calculation indicated the need for 50 participants in each condition', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 6 months follow-up', 'description': 'Self-reported depressive symptoms 6 months after the ABM intervention based on a 21-item scale. Each item is scored 0-3 (where scoring description is adapted to each item), yielding a score from 0-63.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants that had baseline and/or outcome data.'}, {'type': 'PRIMARY', 'title': 'State Rumination: Brief State Rumination Inventory (BSRI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Affective Bias Modification', 'description': 'Computer based Affective Bias Modification\n\nAffective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the active condition, the probe appears at the location of the most positive stimuli of each pair in 87 % of trials (encouraging a positive affective bias). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.'}, {'id': 'OG001', 'title': 'Sham Affective Bias Modification', 'description': 'Computer based sham Affective Bias Modification\n\nSham Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the sham condition, the probe appears at the location of the most positive stimuli of each pair in 50 % of trials (no contingency between facial expressions shown and the probe location). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.'}, {'id': 'OG002', 'title': 'Assesment Only', 'description': 'No intervention was given.'}], 'classes': [{'categories': [{'measurements': [{'value': '-.7', 'spread': '13.3', 'groupId': 'OG000'}, {'value': '-5.8', 'spread': '19.1', 'groupId': 'OG001'}, {'value': '-.8', 'spread': '7.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and two weeks follow up.', 'description': 'Change in self-reported state rumination after the stress induction from pre to post intervention on a 8 item scale. Difference score: BSRI post intervention - BRSI Baseline. A negative score means reduction in state rumination over the intervention. Each item is scored on a 0-100 Visual Analogue Scale. The total score divided by 8 to provide the mean item total score, hence the min= 0 and max = 100 for each of the BSRI assessment time points. It was hypothesized that change in state rumination over the intervention period would mediate the effect of ABM on depressive symptoms at six months follow up.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '10 persons were lost to follow up'}, {'type': 'PRIMARY', 'title': 'State Rumination: Brief State Rumination Inventory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Affective Bias Modification', 'description': 'Computer based Affective Bias Modification\n\nAffective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the active condition, the probe appears at the location of the most positive stimuli of each pair in 87 % of trials (encouraging a positive affective bias). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.'}, {'id': 'OG001', 'title': 'Sham Affective Bias Modification', 'description': 'Computer based sham Affective Bias Modification\n\nSham Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the sham condition, the probe appears at the location of the most positive stimuli of each pair in 50 % of trials (no contingency between facial expressions shown and the probe location). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.'}, {'id': 'OG002', 'title': 'Assessment Only', 'description': 'No intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.2', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '32.3', 'spread': '15.8', 'groupId': 'OG001'}, {'value': '23.4', 'spread': '20.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At two weeks follow up.', 'description': 'Self-reported state rumination after stress induction on a 8 item scale. Each item is scored on a 0-100 Visual Analogue Scale, yielding a score from 0-800, which is reported divided by 8 to provide a mean total item score. Hence the min= 0 and max = 100. A higher score indicates more state rumination.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '10 participants were lost to follow-up.'}, {'type': 'SECONDARY', 'title': 'Affective Bias: Dot-probe Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Affective Bias Modification', 'description': 'Computer based Affective Bias Modification\n\nAffective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the active condition, the probe appears at the location of the most positive stimuli of each pair in 87 % of trials (encouraging a positive affective bias). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.'}, {'id': 'OG001', 'title': 'Sham Affective Bias Modification', 'description': 'Computer based sham Affective Bias Modification\n\nSham Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the sham condition, the probe appears at the location of the most positive stimuli of each pair in 50 % of trials (no contingency between facial expressions shown and the probe location). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.'}, {'id': 'OG002', 'title': 'Assessment Only', 'description': 'No intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.0', 'spread': '28.4', 'groupId': 'OG000'}, {'value': '9.4', 'spread': '40.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to two weeks follow up', 'description': 'Change in reaction time in milliseconds to probes in the location of the positive facial stimuli compared to probes in the location of the negative stimuli. Positive number implies reduction in negative bias.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Nine participants were lost to follow up. Technical error led to loss of data on the follow up in the assessment only condition.'}, {'type': 'SECONDARY', 'title': 'Symptom Network Change: Experience Sampling of Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Affective Bias Modification', 'description': 'Computer based Affective Bias Modification\n\nAffective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the active condition, the probe appears at the location of the most positive stimuli of each pair in 87 % of trials (encouraging a positive affective bias). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.'}, {'id': 'OG001', 'title': 'Sham Affective Bias Modification', 'description': 'Computer based sham Affective Bias Modification\n\nSham Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the sham condition, the probe appears at the location of the most positive stimuli of each pair in 50 % of trials (no contingency between facial expressions shown and the probe location). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.'}, {'id': 'OG002', 'title': 'Assesment Only', 'description': 'No intervention was given.'}], 'classes': [{'categories': [{'measurements': [{'value': '.0175', 'spread': '.0819', 'groupId': 'OG000'}, {'value': '-.685', 'spread': '.789', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From two weeks prior to baseline to two weeks after the two-week intervention.', 'description': 'Changed centrality of rumination in networks estimated based on a 9-item experience sampling questionnaire of self-reported depressive symptoms scored on a 0-100 visual analogue scale (higher value, more symptoms; reversing interest, positive affect and activity; Kraft et al., 2023, Psychiatry Research Communications). Two person-specific networks (pre and post-intervention) were estimated using the var1-function in the R package psychonetrics, with full-information maximum likelihood estimator, based on the experience sampling questionnaires that were administrated 5 times/day for 14 days before and after the intervention. Centrality of rumination in these networks were calculated using qgraph (Epskamp et al., 2012) and standardized. Change in rumination centrality was calculated as difference between rumination centrality in the two estimated networks, and higher number indicate increased centrality of rumination (post-pre).', 'unitOfMeasure': 'standardized values', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-processing of ESM-data excluded participants who responded to less than 30 measurements.'}, {'type': 'SECONDARY', 'title': 'Symptom Network: Experience Sampling of Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Affective Bias Modification', 'description': 'Computer based Affective Bias Modification\n\nAffective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the active condition, the probe appears at the location of the most positive stimuli of each pair in 87 % of trials (encouraging a positive affective bias). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.'}, {'id': 'OG001', 'title': 'Sham Affective Bias Modification', 'description': 'Computer based sham Affective Bias Modification\n\nSham Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the sham condition, the probe appears at the location of the most positive stimuli of each pair in 50 % of trials (no contingency between facial expressions shown and the probe location). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.'}, {'id': 'OG002', 'title': 'Assessment Only', 'description': 'No intervention was given.'}], 'classes': [{'categories': [{'measurements': [{'value': '.108', 'spread': '.785', 'groupId': 'OG000'}, {'value': '-.230', 'spread': '.824', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Two weeks after the two-week intervention.', 'description': 'Centrality of rumination in networks based on a 9-item experience sampling questionnaire of self-reported depressive symptoms scored on a 0-100 visual analogue scale (higher value, more symptoms; reversing interest, positive affect and activity; Kraft et al., 2023, Psychiatry Research Communications). Person-specific networks were estimated using the var1-function in the R package psychonetrics, with full-information maximum likelihood estimator, based on the experience sampling questionnaires that were administrated 5 times/day for 14 days after the two-week intervention. Centrality of rumination in this network was calculated using qgraph (Epskamp et al., 2012) and standardized. Higher number indicate higher centrality of rumination.', 'unitOfMeasure': 'standardized values', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who responded to 30 measurements or more.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Affective Bias Modification', 'description': 'Computer based Affective Bias Modification\n\nAffective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the active condition, the probe appears at the location of the most positive stimuli of each pair in 87 % of trials (encouraging a positive affective bias). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.'}, {'id': 'FG001', 'title': 'Sham Affective Bias Modification', 'description': 'Computer based sham Affective Bias Modification\n\nSham Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the sham condition, the probe appears at the location of the most positive stimuli of each pair in 50 % of trials (no contingency between facial expressions shown and the probe location). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.'}, {'id': 'FG002', 'title': 'Assessment Only', 'description': 'Only assessments were conducted.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Participants were recruited between Nov 19, 2019, and Aug 17, 2021 using local advertisements and social media. Entrance to the trial was via self-referral by phone or online registration.', 'preAssignmentDetails': 'Did not meet the inclusion criteria (N=4), Declined to participate (n=4), Not able to get in contact with (N=4).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Affective Bias Modification', 'description': 'Computer based Affective Bias Modification\n\nAffective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the active condition, the probe appears at the location of the most positive stimuli of each pair in 87 % of trials (encouraging a positive affective bias). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.'}, {'id': 'BG001', 'title': 'Sham Affective Bias Modification', 'description': 'Computer based sham Affective Bias Modification\n\nSham Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the sham condition, the probe appears at the location of the most positive stimuli of each pair in 50 % of trials (no contingency between facial expressions shown and the probe location). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.'}, {'id': 'BG002', 'title': 'Assesment Only', 'description': 'No intervention.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '44.3', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '43.2', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '36.8', 'spread': '18.2', 'groupId': 'BG002'}, {'value': '43.7', 'spread': '11.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Technical problems led to missing data for two participant.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Norway', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education level (ISCED)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '5.8', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '4.8', 'spread': '2.1', 'groupId': 'BG002'}, {'value': '5.7', 'spread': '1.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "International Standard Classification of Education (ISCED), min=0, max=8, value represents average education level for the group. Higher score means higher education.\n\nISCED 0: Early childhood education ('less than primary' for educational attainment) ISCED 1: Primary education ISCED 2: Lower secondary education ISCED 3: Upper secondary education ISCED 4: Post-secondary non-tertiary education ISCED 5: Short-cycle tertiary education ISCED 6: Bachelor's or equivalent level ISCED 7: Master's or equivalent level ISCED 8: Doctoral or equivalent level", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Technical problems led to missing data for two participants.'}, {'title': "Beck's Depression Inventory (BDI-II)", 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '23.1', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '26.3', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '18.2', 'spread': '3.8', 'groupId': 'BG002'}, {'value': '24.4', 'spread': '9.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Becks Depression Inventory-II (BDI-II) Self-report scale including 21 items. Likert scale 0-3. Higher scores represent more severe depression symptoms. Min = 0, Max = 63. The presented value is the average total score per group.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Technical problems led to missing data for two participants.'}, {'title': "Beck's Anxiety Inventory (BAI)", 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '13.1', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '16.2', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '12.0', 'spread': '7.5', 'groupId': 'BG002'}, {'value': '14.6', 'spread': '8.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Self-report scale including 19 items. Likert scale 0-3. Min = 0, Max = 57. The average total score per group is reported. Higher scores represent more severe anxiety symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Technical problems led to missing data for one participant.'}, {'title': 'Alcohol Use Disorder Identification Test (AUDIT)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5.8', 'spread': '4.7', 'groupId': 'BG000'}, {'value': '5.5', 'spread': '5.6', 'groupId': 'BG001'}, {'value': '3.6', 'spread': '5.5', 'groupId': 'BG002'}, {'value': '5.5', 'spread': '5.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Self-report scale including 9 items. Likert scale 0-4. Min = 0, Max = 36. The average total score per groups is reported. Higher scores implies increased risk of alcohol use disorder.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Technical problems led to missing data for one participant.'}, {'title': 'Brief State Rumination Inventory (BSRI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '36.4', 'spread': '18.7', 'groupId': 'BG000'}, {'value': '38.3', 'spread': '17.5', 'groupId': 'BG001'}, {'value': '22.3', 'spread': '20.7', 'groupId': 'BG002'}, {'value': '36.6', 'spread': '18.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Measures state rumination in response to a stress induction on a 8-item scale on a 0-100 visual analogue scale. The value reported is the total score divided by 8. Min = 0, max = 100.\n\nHigher values represent more state rumination.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Technical problems led to missing data for one participant. Data for this outcome measure was only obtained at baseline and post-intervention, not at 6 months follow-up, as the intention of adopting this measure was to investigate if it mediated the association between the intervention and the primary outcome.'}, {'title': 'Attentional bias', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '-10.7', 'spread': '26.4', 'groupId': 'BG000'}, {'value': '-4.7', 'spread': '36.0', 'groupId': 'BG001'}, {'value': '-17.1', 'spread': '29.3', 'groupId': 'BG002'}, {'value': '-8.1', 'spread': '15.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'One session of computerized sham Attentional Bias Modification (ABM), which is based on a dot probe-task, conducted within the lab setting. The value presented is the difference in average reaction time to targets displayed in the location of the previously presented negative stimuli compared to the average reaction time to targets displayed in the location of the relatively more positive (happy-neutral) stimuli, presented in milliseconds. A positive value represents a bias away from negative stimuli, while a negative value represents a bias towards negative.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Technical problems led to missing data for one participant. Data for this outcome measure was only obtained at baseline and post-intervention, not at 6 months follow-up, as the intention of adopting this measure was to investigate if the intervention modified its intended mechanism'}], 'populationDescription': '16 persons withdrew before baseline assessment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-23', 'size': 626240, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-29T09:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2022-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-10', 'studyFirstSubmitDate': '2019-10-10', 'resultsFirstSubmitDate': '2023-02-02', 'studyFirstSubmitQcDate': '2019-10-21', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-10', 'studyFirstPostDateStruct': {'date': '2019-10-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-reported Depressive Symptoms: Becks Depression Inventory-II', 'timeFrame': 'At 6 months follow-up', 'description': 'Self-reported depressive symptoms 6 months after the ABM intervention based on a 21-item scale. Each item is scored 0-3 (where scoring description is adapted to each item), yielding a score from 0-63.'}, {'measure': 'State Rumination: Brief State Rumination Inventory (BSRI)', 'timeFrame': 'At baseline and two weeks follow up.', 'description': 'Change in self-reported state rumination after the stress induction from pre to post intervention on a 8 item scale. Difference score: BSRI post intervention - BRSI Baseline. A negative score means reduction in state rumination over the intervention. Each item is scored on a 0-100 Visual Analogue Scale. The total score divided by 8 to provide the mean item total score, hence the min= 0 and max = 100 for each of the BSRI assessment time points. It was hypothesized that change in state rumination over the intervention period would mediate the effect of ABM on depressive symptoms at six months follow up.'}, {'measure': 'State Rumination: Brief State Rumination Inventory', 'timeFrame': 'At two weeks follow up.', 'description': 'Self-reported state rumination after stress induction on a 8 item scale. Each item is scored on a 0-100 Visual Analogue Scale, yielding a score from 0-800, which is reported divided by 8 to provide a mean total item score. Hence the min= 0 and max = 100. A higher score indicates more state rumination.'}], 'secondaryOutcomes': [{'measure': 'Affective Bias: Dot-probe Task', 'timeFrame': 'From baseline to two weeks follow up', 'description': 'Change in reaction time in milliseconds to probes in the location of the positive facial stimuli compared to probes in the location of the negative stimuli. Positive number implies reduction in negative bias.'}, {'measure': 'Symptom Network Change: Experience Sampling of Depressive Symptoms', 'timeFrame': 'From two weeks prior to baseline to two weeks after the two-week intervention.', 'description': 'Changed centrality of rumination in networks estimated based on a 9-item experience sampling questionnaire of self-reported depressive symptoms scored on a 0-100 visual analogue scale (higher value, more symptoms; reversing interest, positive affect and activity; Kraft et al., 2023, Psychiatry Research Communications). Two person-specific networks (pre and post-intervention) were estimated using the var1-function in the R package psychonetrics, with full-information maximum likelihood estimator, based on the experience sampling questionnaires that were administrated 5 times/day for 14 days before and after the intervention. Centrality of rumination in these networks were calculated using qgraph (Epskamp et al., 2012) and standardized. Change in rumination centrality was calculated as difference between rumination centrality in the two estimated networks, and higher number indicate increased centrality of rumination (post-pre).'}, {'measure': 'Symptom Network: Experience Sampling of Depressive Symptoms', 'timeFrame': 'Two weeks after the two-week intervention.', 'description': 'Centrality of rumination in networks based on a 9-item experience sampling questionnaire of self-reported depressive symptoms scored on a 0-100 visual analogue scale (higher value, more symptoms; reversing interest, positive affect and activity; Kraft et al., 2023, Psychiatry Research Communications). Person-specific networks were estimated using the var1-function in the R package psychonetrics, with full-information maximum likelihood estimator, based on the experience sampling questionnaires that were administrated 5 times/day for 14 days after the two-week intervention. Centrality of rumination in this network was calculated using qgraph (Epskamp et al., 2012) and standardized. Higher number indicate higher centrality of rumination.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rumination', 'Attention bias modification', 'Transdiagnostic'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '37695740', 'type': 'DERIVED', 'citation': 'Bo R, Kraft B, Joormann J, Jonassen R, Harmer CJ, Landro NI. Cognitive predictors of stress-induced mood malleability in depression. Anxiety Stress Coping. 2024 Mar;37(2):278-292. doi: 10.1080/10615806.2023.2255531. Epub 2023 Sep 11.'}, {'pmid': '36617964', 'type': 'DERIVED', 'citation': 'Bo R, Kraft B, Pedersen ML, Joormann J, Jonassen R, Osnes K, Harmer CJ, Landro NI. The effect of attention bias modification on depressive symptoms in a comorbid sample: a randomized controlled trial. Psychol Med. 2023 Oct;53(13):6389-6396. doi: 10.1017/S0033291722003956. Epub 2023 Jan 9.'}], 'seeAlsoLinks': [{'url': 'https://www.sv.uio.no/psi/english/research/projects/affective-bias-modification/', 'label': 'Project web page'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect of a computerized intervention for depressive symptoms called Affective Bias Modification (ABM). A third of the patients will receive active ABM, a third will receive sham ABM and a third will undergo assessment only. The study will investigate if rumination mediates the effect of the intervention and investigate if specific symptom profiles affect the effect of the intervention.', 'detailedDescription': 'A main aim of the project is to investigate how the effects of an ABM intervention on depressive symptoms are mediated by transdiagnostic rumination and how characteristics of the symptom network moderate these effects. The Affective Bias Modification Task (ABM) will be applied in a randomized controlled, double blind clinical trial with 6 months follow-up. Personalized networks are generated from prospective assessment of depression-related processes at baseline and follow-ups. Patients (n = 150) will be recruited from out-patient clinics at Diakonhjemmet Hospital, and randomized into one of three conditions: active, sham and assessment only. Patients aged 18-65 with depression (major depressive disorder) or bipolar disorder 2, with or without comorbid anxiety and/or alcohol use disorder will be included. The main hypothesis is that subjects who are in the active ABM group will exhibit less tendency for stress related (state) rumination compared to those in the placebo group. Active vs placebo ABM will decrease depressive symptoms (6 months) and this effect will be mediated by the change in state rumination. Densely connected symptom network and high strength centrality of rumination at baseline will moderate the effect of ABM. By combining mechanisms research with a personalized symptom network approach, this study will be in the forefront of understanding how a drug-free treatment option works and for whom it works best.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Current or remitted Major Depressive Disorder, with or without anxiety, with or without alcohol use disorder\n\nExclusion Criteria:\n\n* Neurological disorder, mania, and/or psychosis.'}, 'identificationModule': {'nctId': 'NCT04137367', 'briefTitle': 'A Personalized Approach to Effects of Affective Bias Modification on Symptom Change and Rumination', 'organization': {'class': 'OTHER', 'fullName': 'University of Oslo'}, 'officialTitle': 'A Personalized Approach to Effects of Affective Bias Modification on Symptom Change and Rumination', 'orgStudyIdInfo': {'id': '2019/FO249225'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Affective Bias Modification', 'description': 'Computer based Affective Bias Modification', 'interventionNames': ['Behavioral: Affective bias modification']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Affective Bias Modification', 'description': 'Computer based sham Affective Bias Modification', 'interventionNames': ['Behavioral: Sham Affective bias modification']}, {'type': 'NO_INTERVENTION', 'label': 'Assesment only', 'description': 'Only assessments are conducted'}], 'interventions': [{'name': 'Affective bias modification', 'type': 'BEHAVIORAL', 'otherNames': ['Attention Bias Modification'], 'description': 'In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the active condition, the probe appears at the location of the most positive stimuli of each pair in 87 % of trials (encouraging a positive affective bias). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.', 'armGroupLabels': ['Active Affective Bias Modification']}, {'name': 'Sham Affective bias modification', 'type': 'BEHAVIORAL', 'otherNames': ['Sham Attention bias modification'], 'description': 'In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the sham condition, the probe appears at the location of the most positive stimuli of each pair in 50 % of trials (no contingency between facial expressions shown and the probe location). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.', 'armGroupLabels': ['Sham Affective Bias Modification']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0317', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Department of Psychology', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Nils Inge Landrø, Dr.Philos', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oslo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oslo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Extrastiftelsen', 'class': 'OTHER'}, {'name': 'Diakonhjemmet Hospital', 'class': 'OTHER'}, {'name': 'University of Oxford', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Nils Inge Landrø', 'investigatorAffiliation': 'University of Oslo'}}}}