- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07346911
Digital Interventions for Relapse Prevention in Adolescence (DigiTIFF)
Some adolescents experience periods of anxiety and/or depression, and some find that these periods return over time. The purpose of this study is to examine whether digital interventions-where individuals work systematically with their own thoughts and feelings during periods when they feel well-can help them maintain well-being for longer.
The study includes adolescents aged 16-19 who have previously experienced episodes of depression and/or anxiety to a degree that led them to seek help (e.g., from a school nurse, general practitioner, health clinic, or child and adolescent mental health service). Through a research app on their smartphones, participants complete tasks and answer questionnaires. The study is fully digital. Some participants meet with a therapist in digital group sessions, while others work independently with the digital content.
We will also examine the cost-benefit aspects of offering such interventions. If the study achieves its goals, digital interventions may eventually become a service offered to adolescents recovering from depression and anxiety.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ragnhild Bø, Ph.D.
- Phone Number: +47 41904595
- Email: ragnhild.bo@psykologi.uio.no
Study Locations
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-
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Oslo, Norway
- University of Oslo
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Contact:
- Ragnhild Bø, PhD
- Phone Number: +47 41904595
- Email: ragnhild.bo@psykologi.uio.no
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Currently in full or partial remission for a minimum of 2 months from a depressive disorder or an anxiety disorder as defined by self-reported scores on RCADS-47: previous episode(s) of t-score > 65 and current t-score =<65.
- Native or fluent Scandinavian language skills.
- Willingness to take part even when allocated to the non-preferred arm of the trial.
Exclusion Criteria:
- Ongoing depressive disorder, ongoing anxiety disorder as defined by current t-score =<65 on RCADS-47.
- Recent completion of one of the interventions in the two interventional arms.
- no available smartphone.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: App intervention
A transdiagnostic, self-guided CBT app:
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A transdiagnostic, self-guided CBT app, called TankeVirus (literally translated Thought Viruses), consisting of three components:
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Experimental: Group intervention
A transdiagnostic, mastery course for groups, delivered weekly in webinar format over three sessions.
It includes videos and group discussions.
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Group-based webinar offering psychoeducation based on principles of CBT.
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No Intervention: Assessment only
Only assessment will be conducted.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relapse: Number of participants scoring above the diagnostic cut-off on the PHQ-9 modified for teens during the 12-month follow-up.
Time Frame: From enrollment to the end of follow-up at 12-months.
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To use the PHQ-9 as a diagnostic aid for Major Depressive Disorder:
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From enrollment to the end of follow-up at 12-months.
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Time until relapse; reaching the diagnostic criteria of MDD according to PHQ-9 modified for teens
Time Frame: From enrollment to 12-months follow-up
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Number of days until the diagnostic criteria of MDD as assessed PHQ-9 modified for teens has been reached. - Questions 1 and/or 2 need to be endorsed as a "2" or "3"
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From enrollment to 12-months follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Repetitive negative thinking (RNT-10)
Time Frame: At enrollment, and at 3, 6 and 12 months follow-up
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Assess transdiagnostic repetitive negative thinking
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At enrollment, and at 3, 6 and 12 months follow-up
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Somatic complaints (SSS8)
Time Frame: At enrollment, and at 3, 6, and 12-months follow-up.
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Somatic complaints based on sum score of all items
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At enrollment, and at 3, 6, and 12-months follow-up.
|
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EPOCH Measure of Adolescent Well-Being
Time Frame: At baseline, 3, 6 and 12-months follow-up.
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A 20-item validated questionnaire (4 items per domain; Engagement, Perseverance, Optimism, Connectedness, Happiness) on a 1-5 Likert scale (1=Almost Never, 5=Almost Always) resulting in domain scores, reflecting strengths in these positive psychological areas crucial for youth well-being.
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At baseline, 3, 6 and 12-months follow-up.
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Health related quality of life
Time Frame: At baseline, 3, 6 and 12-months follow-up.
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EQ-5D-5L will be used to assess five domains of patient reported outcomes and for economic evaluation of the interventions.
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At baseline, 3, 6 and 12-months follow-up.
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Health related quality of life - Visual Analog Scale
Time Frame: At baseline, 3, 6 and 12-months follow-up.
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EQ VAS will be used to assess patient reported outcomes for self-rated health and for economic evaluation of the interventions.
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At baseline, 3, 6 and 12-months follow-up.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Client satisfaction questionnaires (CSQ-I)
Time Frame: At 3 months follow-up.
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The 8-item questionnaire assesses how satisfied the participants are with the interventions, only administrated to those who are in the interventional arms.
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At 3 months follow-up.
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 870757
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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