Digital Interventions for Relapse Prevention in Adolescence

NCT07346911 | Not Yet Recruiting

• 1 other identifier: 870757
• Study Type: interventional
• Target: 495
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Transdiagnostic interventions

Outcome Measures

Primary Outcomes (2)

• 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."

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

• 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."

  From enrollment to 12-months follow-up

Secondary Outcomes (5)

• Repetitive negative thinking (RNT-10)

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

• Somatic complaints (SSS8)

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

• EPOCH Measure of Adolescent Well-Being

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

• Health related quality of life

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

• Health related quality of life - Visual Analog Scale

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

Other Outcomes (1)

• Client satisfaction questionnaires (CSQ-I)

  At 3 months follow-up.

Study Arms (3)

App intervention

EXPERIMENTAL

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

Group intervention

EXPERIMENTAL

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

Behavioral: Transdiagnostic mastery course

Assessment only

NO INTERVENTION

Only assessment will be conducted.

Interventions

Transdiagnostic mastery course BEHAVIORAL

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

Group intervention

Transdiagnostic app intervention BEHAVIORAL

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.

App intervention

Eligibility Criteria

• Age: 16 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oslo: lead

Study Sites (1)

University of Oslo

Oslo, Norway

Location

Related Links

• Project webpage

MeSH Terms

Conditions

Anxiety Disorders; Phobic Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Ragnhild Bø, Ph.D.

CONTACT

+47 41904595; ragnhild.bo@psykologi.uio.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 16, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

NO (1)