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Not yet recruiting NCT07346911

Digital Interventions for Relapse Prevention in Adolescence

No phase Interventional Major Depression Disorder ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transdiagnostic app intervention, Transdiagnostic mastery course.
Who it may be relevant to
Registry conditions: Major Depression Disorder, ANXIETY DISORDERS (or Anxiety and Phobic Neuroses). Basic parameters: 16 years — 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral Transdiagnostic 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
  • Behavioral Transdiagnostic mastery course
    Group-based webinar offering psychoeducation based on principles of CBT.

Primary outcome measures

  • 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.]
  • 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]
Secondary outcome measures (5)
  • Repetitive negative thinking (RNT-10) [Time frame: At enrollment, and at 3, 6 and 12 months follow-up]
  • Somatic complaints (SSS8) [Time frame: At enrollment, and at 3, 6, and 12-months follow-up.]
  • EPOCH Measure of Adolescent Well-Being [Time frame: At baseline, 3, 6 and 12-months follow-up.]
  • Health related quality of life [Time frame: At baseline, 3, 6 and 12-months follow-up.]
  • Health related quality of life - Visual Analog Scale [Time frame: At baseline, 3, 6 and 12-months follow-up.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Norway · 1 center
  • University of Oslo — Oslo

Identifiers

NCT: NCT07346911 · 870757

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗