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NCT Number: NCT07346911

Digital Interventions for Relapse Prevention in Adolescence

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.

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Key information

Conditions

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

Age range

16 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transdiagnostic app intervention

Behavioral

A transdiagnostic, self-guided CBT app, called TankeVirus (literally translated Thought Viruses), consisting of three components:

  • Standardized self-assessment for mental health: 'Test your psychological immune system'.
  • 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).
  • 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.

Transdiagnostic mastery course

Behavioral

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

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.

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

    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."

  2. 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

    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."

Secondary outcomes

  1. Repetitive negative thinking (RNT-10)

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

    Assess transdiagnostic repetitive negative thinking

  2. Somatic complaints (SSS8)

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

    Somatic complaints based on sum score of all items

  3. EPOCH Measure of Adolescent Well-Being

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

    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.

  4. Health related quality of life

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

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

  5. Health related quality of life - Visual Analog Scale

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

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

Other outcomes

  1. Client satisfaction questionnaires (CSQ-I)

    Time frame: At 3 months follow-up.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ragnhild Bø, Ph.D.

CONTACT

[email protected]

+47 41904595

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Registry information

Acronym: DigiTIFF

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 16, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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