ClinicalTrials.gg
RecruitingNCT07346911DigiTIFFUpdated Nov 5, 2026

Digital Interventions for Relapse Prevention in Adolescence

An interventional study of Transdiagnostic app intervention and Transdiagnostic mastery course in Major Depression Disorder and ANXIETY DISORDERS (or Anxiety and Phobic Neuroses), sponsored by University of Oslo. Recruiting at 1 site in Norway. Open to participants aged 16 Years to 19 Years. Per ClinicalTrials.gov, last updated 2026-11-05.

Primary conditionPhobic DisordersRegistry: Anxiety DisordersReclassifiedWhy we changed it
Registry
Anxiety Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Phobic Disorders
Why
  1. The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it.
  2. The study's listed conditions name Phobic Disorders, a narrower term within Anxiety Disorders.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Oslo · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.
Updated Nov 5, 2026Now RecruitingStudy documents posted+4 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
495
Allocation
Randomized
Ages
16 Years to 19 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Major Depression Disorder
  • ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)

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Keywords

  • Transdiagnostic interventions
03

In context

Phobic Disorders Reclassified

84 studies on the registry are indexed under Phobic Disorders; 15 are open to participants now.

This study's planned enrollment of 495 is above the median of 66 across 69 interventional studies indexed under Phobic Disorders.

Browse Phobic Disorders studies →

Lead sponsor

University of Oslo is the lead sponsor of 177 studies on the registry; 24 are open to participants now.

Compared within Phobic Disorders, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
16 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
495 participants (estimated)

Study arms

  • Experimental
    App intervention

    A transdiagnostic, self-guided CBT app: 1. Standardized self-assessment for mental health: 'Test your psychological immune system'. 2. Educational mini-series: A 30-minute, entertaining video series that teaches users to build resilience by addressing essential needs like sleep (psychological immune system), recognizing negative thought patterns (thought viruses), and developing healthier coping mechanisms (psychological vitamins). 3. Daily practice: Over 20 days, users receive a short, 1-2-minute video each morning. These videos provide practical tips, small experiments, or simple tasks designed to help users integrate healthier coping strategies into their daily lives.

    Behavioral: Transdiagnostic app intervention

  • Experimental
    Group intervention

    A transdiagnostic, mastery course for groups, delivered weekly in webinar format over three sessions. It includes videos and group discussions.

    Behavioral: Transdiagnostic mastery course

  • No intervention
    Assessment only

    Only assessment will be conducted.

Interventions

  • BehavioralTransdiagnostic app intervention

    A transdiagnostic, self-guided CBT app, called TankeVirus (literally translated Thought Viruses), consisting of three components: 1. Standardized self-assessment for mental health: 'Test your psychological immune system'. 2. Educational mini-series: A 30-minute, entertaining video series that teaches users to build resilience by addressing essential needs like sleep (psychological immune system), recognizing negative thought patterns (thought viruses), and developing healthier coping mechanisms (psychological vitamins). 3. Daily practice: Over 20 days, users receive a short, 1-2-minute video each morning. These videos provide practical tips, small experiments, or simple tasks designed to help users integrate healthier coping strategies into their daily lives.

  • BehavioralTransdiagnostic mastery course

    Group-based webinar offering psychoeducation based on principles of CBT.

06

What researchers measure

Primary outcomes

  1. Relapse: Number of participants scoring above the diagnostic cut-off on the PHQ-9 modified for teens during the 12-month follow-up.

    To use the PHQ-9 as a diagnostic aid for Major Depressive Disorder: * Questions 1 and/or 2 need to be endorsed as a "2" or "3" * Need five or more positive symptoms (positive is defined by a "2" or "3" in questions 1-8 and "1", "2", or "3" in question 9). * The functional impairment question (How difficult….) needs to be rated at least as "somewhat difficult."

    Time frame: From enrollment to the end of follow-up at 12-months.

  2. Time until relapse; reaching the diagnostic criteria of MDD according to PHQ-9 modified for teens

    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" * Need five or more positive symptoms (positive is defined by a "2" or "3" in questions 1-8 and by a "1", "2", or "3" in question 9). * The functional impairment question (How difficult….) needs to be rated at least as "somewhat difficult."

    Time frame: From enrollment to 12-months follow-up

Secondary outcomes

  1. Repetitive negative thinking (RNT-10)

    Assess transdiagnostic repetitive negative thinking

    Time frame: At enrollment, and at 3, 6 and 12 months follow-up

  2. Somatic complaints (SSS8)

    Somatic complaints based on sum score of all items

    Time frame: At enrollment, and at 3, 6, and 12-months follow-up.

  3. EPOCH Measure of Adolescent Well-Being

    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.

    Time frame: At baseline, 3, 6 and 12-months follow-up.

  4. Health related quality of life

    EQ-5D-5L will be used to assess five domains of patient reported outcomes and for economic evaluation of the interventions.

    Time frame: At baseline, 3, 6 and 12-months follow-up.

  5. Health related quality of life - Visual Analog Scale

    EQ VAS will be used to assess patient reported outcomes for self-rated health and for economic evaluation of the interventions.

    Time frame: At baseline, 3, 6 and 12-months follow-up.

Other outcomes

  1. Client satisfaction questionnaires (CSQ-I)

    The 8-item questionnaire assesses how satisfied the participants are with the interventions, only administrated to those who are in the interventional arms.

    Time frame: At 3 months follow-up.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Related links

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — The dataset underlying the results will be shared together with publications.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Feb 2028, 17 months after the start.

Of 28 interventional studies with no phase under Phobic Disorders, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 44. This study's planned 17 months is below that.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 5, 2026: start Apr 2026 → Aug 2026, primary completion Jun 2027 → Feb 2028 and completion Jun 2027 → Feb 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Dec 22, 2025
First posted
Jan 16, 2026
StartActual
Aug 10, 2026was Apr 2026
Primary completionEst.
Feb 1, 2028was Jun 2027
CompletionEst.
Feb 1, 2028was Jun 2027
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Nov 5, 2026
Sites
University of Oslo is now Recruiting
Nov 5, 2026
Start date
Apr 7, 2026→Aug 10, 2026 (actual)
Nov 5, 2026
Primary completion
Jun 1, 2027→Feb 1, 2028
Nov 5, 2026
Study completion
Jun 1, 2027→Feb 1, 2028
Nov 5, 2026
Documents
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Not yet recruiting→Recruiting
    Documents Study protocol ↗ updated
    University of Oslo is now Recruiting
    Start date Apr 7, 2026→Aug 10, 2026 (now actual)
    Primary completion Jun 1, 2027→Feb 1, 2028
    Study completion Jun 1, 2027→Feb 1, 2028
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07346911
Lead sponsor
University of Oslo
Responsible party
Ragnhild Bø (Researcher, University of Oslo) — Principal investigator
First posted
Jan 16, 2026
Start date
Aug 10, 2026
Primary completion
Feb 1, 2028 (estimated)
Completion
Feb 1, 2028 (estimated)
Last update
Nov 5, 2026

Study contacts

Ragnhild Bø, Ph.D.
Contact
ragnhild.bo@psykologi.uio.no
+47 41904595

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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