Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2026-01-08 @ 3:31 PM
Study NCT ID:
NCT03353961
Status:
COMPLETED
Last Update Posted:
2022-05-05
First Post:
2017-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet Delivered ERITA for Nonsuicidal Self-Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-29', 'studyFirstSubmitDate': '2017-11-02', 'studyFirstSubmitQcDate': '2017-11-21', 'lastUpdatePostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Short version of the Experiences in Close Relationships Scale - Revised Child version', 'timeFrame': 'Change from baseline, once every second week during treatment (0-12 weeks after baseline)', 'description': 'Experiences in close relationships. Ranges from 12-84, with higher scores indicating greater problems.'}, {'measure': 'Generalised Anxiety Disorder 7-item scale', 'timeFrame': 'Change from baseline, once every second week during treatment (0-12 weeks after baseline)', 'description': 'Worry. Ranges 0-21, with higher scores indicating more worry.'}, {'measure': 'Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version', 'timeFrame': 'Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended', 'description': 'Costs associated with psychiatric illness'}, {'measure': 'Kidscreen-10', 'timeFrame': 'Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended', 'description': 'Quality of life. Ranges 11-55, with higher scores indicating higher quality in life.'}, {'measure': 'Patient Internet-delivered cognitive behavioral Adherence Scale', 'timeFrame': '6 and 12 weeks after baseline', 'description': 'Patient adherence to treatment. Ranges from 0-20, with higher scores indicating higher adherence.'}, {'measure': 'Working Alliance Inventory', 'timeFrame': '4 weeks after treatment starts', 'description': 'Working alliance with online therapist'}, {'measure': "The Coping with Children's Negative Emotions Scale Adolescent Version", 'timeFrame': 'Change from baseline, 6 and 12 weeks after treatment starts, 3 and 12 months after treatment has ended', 'description': "Parents' perceived ability to cope with children's negative emotions. Three subscales will be used derived to reflect the specific types of coping response parents tend to use in these situations (punitive reactions, problem focused reactions, and minimization reactions). Each subscale ranges from 1-7."}, {'measure': 'The Client Satisfaction Questionnaire', 'timeFrame': '12 weeks after treatment starts', 'description': 'Client satisfaction with treatment. Ranges from 8-32 with higher scores indicating greater treatment satisfaction.'}, {'measure': 'Adverse Events', 'timeFrame': '12 weeks after treatment starts', 'description': 'Self-rating scale that measures adverse events related to treatment'}, {'measure': 'Credibility/Expectancy Questionnaire', 'timeFrame': '1 week after treatment starts', 'description': 'Treatment credibility and expectancy. Ranges from 0-50 with higher scores indicating greater credibility/expectancy.'}], 'primaryOutcomes': [{'measure': 'Deliberate Self-Harm Inventory Youth version (DSHI-Y)', 'timeFrame': 'Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended', 'description': 'Frequency of nonsuicidal self-injury'}], 'secondaryOutcomes': [{'measure': 'Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)', 'timeFrame': 'Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended', 'description': 'Difficulties in emotion regulation as primary potential mechanism of change. Ranges from 16-80, with higher scores indicating more difficulties.'}, {'measure': 'Difficulties in Emotion Regulation Scale - 36 item version (DERS)', 'timeFrame': 'Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended', 'description': 'Difficulties in emotion regulation. Ranges from 36-180, with higher scores indicating more difficulties.'}, {'measure': 'the 21-item Depression Anxiety Stress Scales (DASS-21)', 'timeFrame': 'Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended', 'description': 'Symptoms of depression, anxiety and stress. Each subscale (depression, anxiety and stress) ranges from 0-21, with higher scores indicating more symptoms.'}, {'measure': 'Borderline Symptom List Supplement', 'timeFrame': 'Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended', 'description': 'Impulsive self-destructive behaviors'}, {'measure': 'Acceptance and Action Questionnaire', 'timeFrame': 'Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended', 'description': 'Acceptance and valued actions. Ranges from 7-49, with higher scores indicating less acceptance and valued actions.'}, {'measure': 'Childrens Global Assessment Scale', 'timeFrame': 'Change from baseline, 16 weeks after treatment starts, 3 months after treatment has ended', 'description': 'Global functioning. Ranges from 1-100, with higher scores indicating better functioning.'}, {'measure': 'The Clinical Global Impressions -Severity and Improvement scales', 'timeFrame': 'Change from baseline, 16 weeks after treatment starts, 3 months after treatment has ended', 'description': 'Global symptom severity and improvement. Severity of illness scale ranges from 1-7, with higher scores indicating higher severity of illness. Global improvement scale ranges from 1-7 with lower scores indicating more improvement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NSSI'], 'conditions': ['Nonsuicidal Self-injury']}, 'referencesModule': {'references': [{'pmid': '39695442', 'type': 'DERIVED', 'citation': 'Ponten M, Flygare O, Bellander M, Karemyr M, Nilbrink J, Hellner C, Ojala O, Bjureberg J. Comparison between clinician and machine learning prediction in a randomized controlled trial for nonsuicidal self-injury. BMC Psychiatry. 2024 Dec 18;24(1):904. doi: 10.1186/s12888-024-06391-x.'}, {'pmid': '37440232', 'type': 'DERIVED', 'citation': 'Bjureberg J, Ojala O, Hesser H, Habel H, Sahlin H, Gratz KL, Tull MT, Claesdotter Knutsson E, Hedman-Lagerlof E, Ljotsson B, Hellner C. Effect of Internet-Delivered Emotion Regulation Individual Therapy for Adolescents With Nonsuicidal Self-Injury Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2322069. doi: 10.1001/jamanetworkopen.2023.22069.'}, {'pmid': '33677832', 'type': 'DERIVED', 'citation': 'Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3(3):CD013667. doi: 10.1002/14651858.CD013667.pub2.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate if Internet delivered emotion regulation individual therapy for adolescents is an efficacious treatment when delivered as adjunctive to treatment as usual compared to a control group consisting of treatment as usual.', 'detailedDescription': "Statistical Analyses\n\nTreatment effects will be evaluated according to the intention-to-treat principle. Primary end-point for all outcomes is post-treatment. Secondary end-point include a controlled 3 month follow-up.\n\nPrimary Analysis\n\nThe primary outcome analysis will include treatment group (ERITA , TAU) and weekly reports of NSSI frequency measured once every week 4 weeks prior to treatment start, once every week during treatment, and once every week four weeks after treatment termination. Regression analysis modelled for count data will be used to estimate trend over time. Four weeks after treatment termination will be considered primary endpoint. Pairwise contrasts (group x time interaction) from the regression model will be used to evaluate between-group differences at primary endpoint (4 weeks after treatment termination).\n\nSecondary Analyses\n\nSecondary outcomes measured once before, during, and after treatment will be analyzed in a similar fashion as for the primary outcome, modelled after data's distribution (count or continuous). Measures collected only once at baseline and post-treatment will be analyzed with regression analyses including treatment group (online ERITA , TAU) as the between-subjects factor, time (baseline to post) as the within-subjects factor, and group × time interactions, modelled after data's distribution (count or continuous).\n\nParallel process latent growth curve modeling will be used to determine whether change in week-to-week emotion dysregulation (DERS-16) during treatment mediate the overall effect of ERITA+ETAU on week-to-week change in the primary outcome self-rated NSSI frequency (DSHI-Y).\n\n3 Month Follow-Up\n\nData collected at 3-month follow-up will be used to determine the extent to which potential treatment gains were maintained both within and between treatment conditions\n\nUpdate 28 April 2022: As a secondary analyses, we also aim to investigate the effect of treatment moderators (primary aim) and predictors (secondary aim) on NSSI frequency one month after treatment termination. This update was submitted prior to conducting the analyses.\n\nThe selection of potential moderators was theoretically and empirically motivated. We will investigate the following variables (measured at baseline):\n\nAge Difficulties in emotion regulation As measured with the Difficulties in Emotion Regulation Scale - 36 item version (DERS) Past month NSSI frequency As measured with the Deliberate Self-Harm Inventory Youth version (DSHI-Y) Global functioning As measured with the Childrens Global Assessment Scale Depressive symptoms As measured with the 21-item Depression Anxiety Stress Scales (DASS-21) Sleep difficulties As measured with the Insomnia Severity Index (ISI) Parental Minimization - discounting or devaluing the child's negative emotions/problems As measured with The Coping with Children's Negative Emotions Scale Adolescent Version (CCNES-A), subscale minimazation Level of suicidality As measured with the MINI-KID International Neuropsychiatric Interview, version 6"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 5 nonsuicidal self-injury episodes past year\n* ≥ 1 nonsuicidal self-injury episodes past month\n* having at least one parent who committed to participate in the parent program\n\nExclusion Criteria:\n\n* Severe suicidal ideation\n* a diagnosis of psychotic or bipolar I disorder or ongoing (past month) substance dependence\n* the presence of co-occurring psychological disorders that required immediate treatment (i.e., severe anorexia nervosa)\n* insufficient understanding of the Swedish language'}, 'identificationModule': {'nctId': 'NCT03353961', 'acronym': 'ERITA', 'briefTitle': 'Internet Delivered ERITA for Nonsuicidal Self-Injury', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Internet Delivered Emotion Regulation Individual Therapy for Adolescents With Nonsuicidal Self-Injury: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2017/10 BIP ERITA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adjunctive Internet-delivered ERITA', 'description': 'Participants will receive 11 weeks of internet-delivered emotion regulation individual therapy with therapist support adjunctive to treatment as usual as provided in the community. The caregiver(s) will receive 6 modules of internet-delivered parent program with therapist support.', 'interventionNames': ['Behavioral: Emotion regulation individual therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as usual', 'description': 'Participants will receive treatment as usual for 11 weeks of treatment as usual as provided in the community.', 'interventionNames': ['Behavioral: Treatment as usual']}], 'interventions': [{'name': 'Emotion regulation individual therapy', 'type': 'BEHAVIORAL', 'description': 'The emotion regulation individual therapy is delivered via an internet platform and includes therapist contact several times per week via the platform.', 'armGroupLabels': ['Adjunctive Internet-delivered ERITA']}, {'name': 'Treatment as usual', 'type': 'BEHAVIORAL', 'description': 'Treatment as usual as provided in the community.', 'armGroupLabels': ['Treatment as usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '113 64', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Centre for Psychiatry Research Karolinska Institutet and Stockholm County Council', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '113 64', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institutet', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Clara Hellner, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, Professor', 'investigatorFullName': 'Clara Hellner Gumpert', 'investigatorAffiliation': 'Karolinska Institutet'}}}}