Mobile-enhanced Group CBT for Adolescents at Risk Severe Mood Disorders

Study Overview
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Brief Summary
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Although cognitive-behavioral therapy (CBT) has shown efficacy in reducing symptoms and rates of mood relapse in adolescents at high risk for severe mood disorders (SMD; i.e., bipolar I/II disorder and recurrent or unremitting major depression), a significant limitation to the CBT's efficacy is the low rate of participant adherence to the prescribed between-session homework tasks. Mobile health applications have the potential to improve adherence to and acceptance of treatment through embedded treatment content, skill-practice, thought and symptom monitoring, all of which are facilitated by reward contingencies and notifications. This study examines whether a mobile application-enhanced CBT can improve participant adherence and treatment acceptance for adolescents at high risk for SMD.

Official Title
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Mobile-enhanced Transdiagnostic Group Treatment for Adolescents at Risk for Severe Mood Disorders

Conditions
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Adolescents, Mood Disorders

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy (CBT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet DSM-5 criteria for at least one past major depressive disorder, persistent depressive disorder, or unspecified bipolar disorder Be 13-17 years old English speaking and able to complete written questionnaires Ability to attend pre-determined group session time(s) Access to a smartphone to engage with the study app Medication usage is acceptable, but not required Exclusion Criteria: Regular use or current abuse of a psychoactive drug Evidence of behavioral problems that are thought to interfere with group treatment Suicidality that requires more intensive treatment Meeting DSM 5 criteria for bipolar I or II disorder, a psychotic disorder, or significant psychiatric symptoms (e.g., self-injurious behavior) that require more intensive treatment Concurrent participation in cognitive-behavioral therapy Inability to travel to study sessions and assessments

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive behavioral therapy (CBT)_no app<br> | Behavioral: Cognitive behavioral therapy (CBT)<br>* Group-based transdiagnostic cognitive-behavioral treatment<br>|
| Experimental: Cognitive behavioral therapy (CBT) with mobile app<br> | Behavioral: Cognitive behavioral therapy (CBT)<br>* Group-based transdiagnostic cognitive-behavioral treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weekly participant adherence | Clinician-rated based on participant report | 3-month study period | 
| Subjective app usability scale | Participant's subjective experience of mobile application. Scores range from 0 - 36 (6 7-point Likert scale items) with higher scores indicating greater subjective usability and acceptability of app | Measured at the end of the 3-month study period | 
| Psychosocial compliance scale | Clinician-rated of participant overall treatment compliance. Scores range from 17-85 (17 5-point Likert scale items) with higher scores indicating greater treatment compliance | 3-month study period | 
| Participant app usage | Frequency of participants' app usage | 3-month study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's Depression Rating Scale, Revised | Measures depressive symptom severity. Scores range from 17-113 (14 7-point items and 3 5-point items) with higher scores indicating greater depressive severity. | Measured prior to treatment (0 months) and the end of the three-month study period. | 
| Young Mania Rating Scale | Measure manic symptom severity. Scores range from 0-60 (7 5-point items and 4 9-point items) with higher scores indicating greater manic severity. | Measured prior to treatment (0 months) and the end of the three-month study period. | 
| Clinical Global Assessment Scale | Measures overall functioning on a 1-100 scale, with higher scores indicating better functioning. | Measured prior to treatment (0 months) and the end of the three-month study period. | 
| Clinical Global Impression | Measures overall clinical functioning from 1-7, with higher scores indicating greater psychiatric severity. | Measured prior to treatment (0 months) and the end of the three-month study period. | 
| Symptom Checklist 90 | Participant-reported psychiatry symptoms. Scores range from 0 - 360 (90 5-point Likert items) with higher scores indicating greater symptom severity. | Measured prior to treatment (0 months) and the end of the three-month study period. | 
| Depression Anxiety & Stress Scale | Participant reported mood, anxiety and stress. Scores range from 0 - 63 (21 4-point items) with higher scores indicating greater distress. | Measured prior to treatment (0 months) and the end of the three-month study period. | 
| KINDL | Quality of life measure. Scores range from 0 - 120 (30 5-point items) with higher scores indicating poorer quality of life. | Measured prior to treatment (0 months) and the end of the three-month study period. | 
| Depression Anxiety & Stress Scale | Parent reported mood, anxiety and stress. Scores range from 0 - 63 (21 4-point items) with higher scores indicating greater distress. | Measured prior to treatment (0 months) and the end of the three-month study period. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive behavioral therapy (CBT), mobile health (mHealth), Group treatment