Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 11:01 AM
Study NCT ID:
NCT05509660
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2022-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transdiagnostic Internet Intervention to Improve Mental Health Among University Students: Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2022-08-08', 'studyFirstSubmitQcDate': '2022-08-19', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Credibility and expectancy Questionnaire (CEQ).', 'timeFrame': 'Baseline', 'description': 'Credibility/expectancy. \\[Feasibility and acceptability measure\\]'}, {'measure': 'Working Alliance Inventory - Short (WAI-S)', 'timeFrame': 'Mid-treatment (4 weeks)', 'description': 'The WAI-S is scale measuring the participants perceived working alliance with their therapist. \\[Feasibility and acceptability measure\\]'}, {'measure': 'The Client Satisfaction Questionnaire-8 (CSQ-8)', 'timeFrame': 'Post-treatment (8 weeks)', 'description': 'Treatment satisfaction \\[Feasibility and acceptability measure\\]'}, {'measure': 'Treatment interest/uptake. Measured in terms of % participants who responded to the study invitation', 'timeFrame': 'Baseline', 'description': 'Interest for intervention \\[Feasibility and acceptability measure\\]'}, {'measure': 'Treatment completion/adherence.', 'timeFrame': 'Post-treatment (8 weeks)', 'description': 'Adherence to the treatment protocol. Measured in terms of % completed modules and % of completed skills practices. \\[Feasibility and acceptability measure\\]'}, {'measure': 'Assessment completion/adherence.', 'timeFrame': 'Post-treatment (8 weeks)', 'description': 'Adherence to assessment plan (% missing data). Measured in terms of % completed measures at post-treatment. \\[Feasibility and acceptability measure\\]'}, {'measure': 'Added therapist support.', 'timeFrame': 'Mid-treatment (4 weeks)', 'description': 'Measured as % of participants who are randomized to receive additional therapist support for the remainder of the treatment period (weeks to 8).'}, {'measure': 'Early treatment termination.', 'timeFrame': 'Post-treatment (8 weeks)', 'description': "Measured as % of participants who decide to end treatment early. This includes reporting participants' reasons for early termination, where provided. \\[Feasibility and acceptability measure\\]"}, {'measure': 'Negative Effects Questionnaire (NEQ-20)', 'timeFrame': 'Mid-treatment (4 weeks)', 'description': 'NEQ-20 investigate negative effects of psychological treatment. Total range is 0-80, with higher values representing a worse outcome. \\[Feasibility and acceptability measure\\]'}], 'secondaryOutcomes': [{'measure': 'Patient Health Questionnaire PHQ-9', 'timeFrame': 'Baseline, during treatment (weekly), post-treatment (8 weeks), follow-up at 6, 12, and 24 months', 'description': 'Change in PHQ-9 at post-treatment and follow-ups as compared to baseline. Primary endpoint: Change post-treatment (8 weeks).'}, {'measure': 'Generalized Anxiety Disorder scale (GAD-7)', 'timeFrame': 'Baseline, during treatment (weekly), post-treatment (8 weeks), follow-up at 6, 12, and 24 months', 'description': 'Change in GAD-7 at post-treatment and follow-ups as compared to baseline. Primary endpoint: Change post-treatment (8 weeks).'}, {'measure': 'World Health Organization Well-being questionnaire (WHO-5).', 'timeFrame': 'Baseline; During treatment (weekly); post-treatment (8 weeks); follow-up at 6, 12, and 24 months', 'description': 'Well-being'}, {'measure': 'Attitudes towards professional help (ATSPPHS)', 'timeFrame': 'Baseline; follow-up at 12 and 24 months', 'description': 'Attitudes towards professional help'}, {'measure': 'Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure (DSM-5 CCSM)', 'timeFrame': 'Baseline; mid-treatment (week 4); post-treatment (8 weeks); follow-up at 6, 12, and 24 months', 'description': 'DSM-5 symptoms'}, {'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': 'Baseline; mid-treatment (4 weeks); post-treatment (8 weeks); follow-up at 6, 12, and 24 months', 'description': 'Insomnia'}, {'measure': 'Behavioral Activation for Depression Scale (BADS-9', 'timeFrame': 'Baseline; mid-treatment (week 4); post-treatment (8 weeks); follow-up at 6, 12, and 24 months', 'description': 'Behavioral Activation'}, {'measure': 'Skills of Cognitive Therapy (SoCT)', 'timeFrame': 'Baseline; mid-treatment (4 weeks); post-treatment (8weeks); 24-month follow-up', 'description': 'Cognitive Therapy skills'}, {'measure': 'World Health Organization Quality of Life Scale (WHOQOL-Bref).', 'timeFrame': 'Baseline; follow-up at 12 and 24 months', 'description': 'Quality of Life'}, {'measure': 'Alcohol Use Disorders Identification Test - Consumption (AUDIT-C).', 'timeFrame': 'Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months', 'description': 'Alcohol Use'}, {'measure': 'Rosenberg Self-Esteem Scale (RESES)', 'timeFrame': 'Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months', 'description': 'Self-Esteem'}, {'measure': 'Connor-Davidson Resilience Scale.', 'timeFrame': 'Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months', 'description': 'Resilience'}, {'measure': 'Difficulties in Emotion-Regulation Scale (DERS-16).', 'timeFrame': 'Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months', 'description': 'Emotion-Regulation'}, {'measure': 'Penn-State Worry Questionnaire (PSWQ)', 'timeFrame': 'Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months', 'description': 'Worry'}, {'measure': 'Big Five Inventory-10 (BFI-10)', 'timeFrame': 'Baseline; follow-up at 12 and 24 months', 'description': 'Personality'}, {'measure': 'Healthcare consumption and productivity loss in patients with a psychiatric disorder (TIC-P)', 'timeFrame': 'Baseline; follow-up at 6, 12, and 24 months', 'description': 'Healthcare consumption and productivity loss'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychological Disorder']}, 'referencesModule': {'references': [{'pmid': '34418224', 'type': 'BACKGROUND', 'citation': 'Andersson C, Bendtsen M, Lindfors P, Molander O, Lindner P, Topooco N, Engstrom K, Berman AH. Does the management of personal integrity information lead to differing participation rates and response patterns in mental health surveys with young adults? A three-armed methodological experiment. Int J Methods Psychiatr Res. 2021 Dec;30(4):e1891. doi: 10.1002/mpr.1891. Epub 2021 Aug 21.'}]}, 'descriptionModule': {'briefSummary': 'This study comprises the pilot phase of a randomized controlled trial (NCT05085756) that will investigate the feasibility of a transdiagnostic CBT-based treatment for symptoms of depression and anxiety offered to Swedish university students. It will offer treatment to participants who have previously responded to a universal online mental health screen conducted in university setting (WHO-WMH-ICS survey).\n\nThe pilot study initially has a prospective single-group design where 30 college students with elevated depressive and/or anxiety symptoms are enrolled in 8 weeks of therapist-guided CBT treatment via the Internet. All participants included will receive treatment. Mid-treatment, participants that are judged to be at risk of treatment failure will be randomized (1:1 ratio) to either continued treatment with no change, or to receive added therapist-support intended to enhance outcome.\n\nPilot study outcomes include various aspects of feasibility: participant uptake, self-reported credibility and expectancy, adherence to treatment protocol and assessments, treatment satisfaction, potential adverse events, causes for premature termination of treatment, and procedures for providing additional therapist support to a subsample of participants after mid-treatment. Within-group effects for primary depression and anxiety measures will be quantified. A range of secondary measures are piloted for the subsequent randomized controlled trial. The assessment points for this study: Baseline; 8 points during treatment; post-treatment; 6-month follow-up; 12-month follow-up; 24 month follow up.\n\nNote. This study is retrospectively registered; this registration was completed prior to any outcome data-analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* College/university student at institution of higher education in Sweden\n* Score 5-19 on the PHQ-9, and/or\n* Score ≥5 on the GAD-7\n* Completed baseline assessment\n\nExclusion Criteria:\n\n* Pharmacotherapy for mental health issue during the past 3 weeks)\n* Concurrent psychological treatment during the past 3 weeks\n* Mild levels of mental ill-health (under cut-off for primary outcome measures)\n* Severe levels of mental ill-health\n* Suicidal ideation or plans'}, 'identificationModule': {'nctId': 'NCT05509660', 'briefTitle': 'Transdiagnostic Internet Intervention to Improve Mental Health Among University Students: Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'E-health Interventions for Common Mental Health Problems Among University Students in Sweden: Pilot Study of Transdiagnostic Internet-based Psychological Treatment', 'orgStudyIdInfo': {'id': '2021-03599P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Therapist-guided internet-based CBT treatment with increased therapist support', 'description': "Intervention/treatment: Behavioral: 'PUMA+'\n\n8-week transdiagnostic CBT with therapist-support. One psychoeducation module followed by two transdiagnostic modules tailored to primary depression or anxiety symptoms, followed by three participant-choice modules, and ending with two transdiagnostic modules (acceptance; maintenance of skills learned). From mid-treatment onwards, participants will be offered increased therapist support.", 'interventionNames': ['Behavioral: PUMA+']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Therapist-guided internet-based CBT treatment with standard therapist-support', 'description': "Intervention/treatment: Behavioral: 'PUMA' Intervention/treatment: Behavioral: 'PUMA'\n\n8-week transdiagnostic CBT with therapist support. One psychoeducation module followed by two transdiagnostic modules tailored to primary depression or anxiety symptoms, followed by three participant-choice modules, and ending with two transdiagnostic modules (acceptance; maintenance of skills learned).", 'interventionNames': ['Behavioral: PUMA']}], 'interventions': [{'name': 'PUMA+', 'type': 'BEHAVIORAL', 'description': 'Transdiagnostic CBT', 'armGroupLabels': ['Therapist-guided internet-based CBT treatment with increased therapist support']}, {'name': 'PUMA', 'type': 'BEHAVIORAL', 'otherNames': ['Transdiagnostic CBT'], 'description': 'Transdiagnostic CBT', 'armGroupLabels': ['Therapist-guided internet-based CBT treatment with standard therapist-support']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75105', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Anne H Berman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Outcome data will be shared as appropriate, but primarily within the WHO-WMH-ICS consortium.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, {'name': 'Malmö University', 'class': 'OTHER'}, {'name': 'Stockholm University', 'class': 'OTHER'}, {'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}