Digital Interventions for Relapse Prevention in Adolescence
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-19
SponsorUniversity of Oslo
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Transdiagnostic app intervention
BehavioralA 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.
Transdiagnostic mastery course
BehavioralGroup-based webinar offering psychoeducation based on principles of CBT.
Treatment groups
495 Participants
are divided into 3 treatment groupsGroup A: App interventionExperimental treatment 1 intervention
Group B: Group interventionExperimental treatment 1 intervention
Group C: Assessment onlyNo intervention 0 interventions
Trial outcomes
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-upSecondary outcomes
1
Repetitive negative thinking (RNT-10)
Assess transdiagnostic repetitive negative thinking
Time frame
At enrollment, and at 3, 6 and 12 months follow-up2
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.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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: