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CompletedNCT04887155Updated May 22, 2025Results posted

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

An interventional study of Cognitive behavioral therapy (CBT) in Adolescents and Mood Disorders, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-05-22.

Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
91
Allocation
Randomized
Ages
13 Years to 17 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Adolescents
  • Mood Disorders

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Keywords

  • cognitive behavioral therapy (CBT)
  • mobile health (mHealth)
  • Group treatment
03

In context

Mood Disorders

584 studies on the registry are indexed under Mood Disorders; 117 are open to participants now.

This study's enrollment of 91 is above the median of 72 across 429 interventional studies indexed under Mood Disorders.

Browse Mood Disorders studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Meet DSM-5 criteria for at least one past major depressive disorder, persistent depressive disorder, or unspecified bipolar disorder
  2. Be 13-17 years old
  3. English speaking and able to complete written questionnaires
  4. Ability to attend pre-determined group session time(s)
  5. Access to a smartphone to engage with the study app
  6. Medication usage is acceptable, but not required

Exclusion criteria

Exclusion Criteria:

  1. Regular use or current abuse of a psychoactive drug
  2. Evidence of behavioral problems that are thought to interfere with group treatment
  3. Suicidality that requires more intensive treatment
  4. 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
  5. Concurrent participation in cognitive-behavioral therapy
  6. Inability to travel to study sessions and assessments
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
91 participants (actual)

Study arms

  • Active comparator
    Cognitive behavioral therapy (CBT)_no app

    Behavioral: Cognitive behavioral therapy (CBT)

  • Experimental
    Cognitive behavioral therapy (CBT) with mobile app

    Behavioral: Cognitive behavioral therapy (CBT)

Interventions

  • BehavioralCognitive behavioral therapy (CBT)

    Group-based transdiagnostic cognitive-behavioral treatment

06

What researchers measure

Primary outcomes

  1. Treatment Skill Practice

    Sum of all treatment skill practices completed through the course of the treatment (based on adolescent report).

    Time frame: 9-week treatment period

  2. Psychosocial Treatment 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.

    Time frame: 9-week treatment

  3. Mobile Application Use

    Frequency of mobile application (app) usage within the condition that received the mobile application, ranging from 0 to unlimited maximum with higher scores indicating more app usage.

    Time frame: 9-week treatment period

Secondary outcomes

  1. Mobile Application Usability Scale

    Mobile application (app) acceptability as rated on a 5-point scale (i.e., minimum = 1, maximum = 5) with higher values indicating greater acceptability

    Time frame: Measured at the end of the 9-week treatment period

  2. 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.

    Time frame: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.

  3. 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.

    Time frame: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.

  4. Clinical Global Assessment Scale

    Measures overall functioning on a 1-100 scale, with higher scores indicating better functioning.

    Time frame: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.

  5. Clinical Global Impression

    Measures overall clinical functioning from 1-7, with higher scores indicating greater psychiatric severity.

    Time frame: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.

  6. Symptom Checklist 90

    Participant-reported psychiatry symptoms. Scores range from 0 - 360 (90 5-point Likert items) with higher scores indicating greater symptom severity.

    Time frame: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.

  7. Difficulties With Emotion Regulation

    Participant reported their difficulties with emotion regulation. Scores range from 36 - 180 (36 5-point items) with higher scores indicating greater distress.

    Time frame: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.

  8. KINDL

    Quality of life measure. Scores range from 0 - 120 (30 5-point items) with higher scores indicating better quality of life.

    Time frame: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.

  9. 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.

    Time frame: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.

07

Results

Posted May 22, 2025
Limitations and caveats
Most of the adolescents were diagnosed with a depressive spectrum disorder. Ratings of skill practice were made based on adolescent and clinician report, but there was no definitive method of confirming skill practice completion in the standard UP group, nor was there any examination of the proficiency/quality of skill practice across both conditions.

Participant flow

We recruited adolescents from two specialty outpatient programs at the UCLA Semel Institute - the Child and Adolescent Mood Disorders Program and the Center for the Assessment and Prevention of Prodromal Syndromes

Participant flow — Overall Study
MilestonePhase I Open Trial-Cognitive Behavioral Therapy (CBT) With Mobile AppPhase II RCT-Cognitive Behavioral Therapy (CBT)_no AppPhase II RCT - Cognitive Behavioral Therapy (CBT) With Mobile App
Started313030
Completed242524
Not completed756

Outcome measures

PrimaryTreatment Skill Practice

Sum of all treatment skill practices completed through the course of the treatment (based on adolescent report).

Time frame:
9-week treatment period
Reported as:
Mean · treatment skill practices
Treatment Skill Practice
treatment skill practicesPhase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile AppPhase II RCT-Cognitive Behavioral Therapy (CBT)_no AppPhase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App
Treatment Skill Practice16.1 ± 8.856.2 ± 33.644.3 ± 43.6
SecondaryMobile Application Usability Scale

Mobile application (app) acceptability as rated on a 5-point scale (i.e., minimum = 1, maximum = 5) with higher values indicating greater acceptability

Time frame:
Measured at the end of the 9-week treatment period
Reported as:
Mean · units on a scale
Mobile Application Usability Scale
units on a scalePhase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile AppPhase II RCT - Cognitive Behavioral Therapy (CBT)_no AppPhase II RCT - Cognitive Behavioral Therapy (CBT) With Mobile App
Mobile Application Usability Scale3.9 ± 1.3—4.3 ± 0.8
PrimaryPsychosocial Treatment 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.

Time frame:
9-week treatment
Reported as:
Mean · units on a scale
Psychosocial Treatment Compliance Scale
units on a scalePhase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile AppPhase II RCT - Cognitive Behavioral Therapy (CBT)_no AppPhase II RCT - Cognitive Behavioral Therapy (CBT) With Mobile App
Psychosocial Treatment Compliance Scale64.6 ± 11.266.42 ± 10.4767.83 ± 9.0
PrimaryMobile Application Use

Frequency of mobile application (app) usage within the condition that received the mobile application, ranging from 0 to unlimited maximum with higher scores indicating more app usage.

Time frame:
9-week treatment period
Reported as:
Mean · units on a scale
Mobile Application Use
units on a scalePhase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile AppPhase II RCT - Cognitive Behavioral Therapy (CBT)_no AppPhase II RCT - Cognitive Behavioral Therapy (CBT) With Mobile App
Mobile Application Use8.8 ± 7.5—9.6 ± 5.0
SecondaryChildren'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.

Time frame:
Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
Reported as:
Mean · score on a scale
Children's Depression Rating Scale, Revised
score on a scalePhase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile AppPhase II RCT - Cognitive Behavioral Therapy (CBT)_no AppPhase II RCT - Cognitive Behavioral Therapy (CBT) With Mobile App
Baseline44.2 ± 11.745.7 ± 10.446.2 ± 11.6
Post-treatment36.3 ± 8.536.8 ± 11.835.9 ± 11.5
3-month follow-up35.9 ± 12.033.3 ± 11.234.4 ± 14.2
SecondaryYoung 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.

Time frame:
Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
Reported as:
Mean · score on a scale
Young Mania Rating Scale
score on a scalePhase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile AppPhase II RCT - Cognitive Behavioral Therapy (CBT)_no AppPhase II RCT - Cognitive Behavioral Therapy (CBT) With Mobile App
Baseline10.1 ± 6.110.3 ± 5.29.6 ± 5.1
Post-treatment9.2 ± 5.37.3 ± 5.16.0 ± 4.2
3-month follow-up7.9 ± 5.26.9 ± 5.86.7 ± 4.1
SecondaryClinical Global Assessment Scale

Measures overall functioning on a 1-100 scale, with higher scores indicating better functioning.

Time frame:
Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
Reported as:
Mean · score on a scale
Clinical Global Assessment Scale
score on a scalePhase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile AppPhase II RCT - Cognitive Behavioral Therapy (CBT)_no AppPhase II RCT - Cognitive Behavioral Therapy (CBT) With Mobile App
Baseline57.9 ± 11.947.7 ± 7.444.5 ± 7.5
Post-treatment65.2 ± 7.054 ± 9.358.1 ± 9.8
3-month follow-up67.8 ± 9.061.7 ± 14.161.7 ± 15.7
SecondaryClinical Global Impression

Measures overall clinical functioning from 1-7, with higher scores indicating greater psychiatric severity.

Time frame:
Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
Reported as:
Mean · score on a scale
Clinical Global Impression
score on a scalePhase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile AppPhase II RCT - Cognitive Behavioral Therapy (CBT)_no AppPhase II RCT - Cognitive Behavioral Therapy (CBT) With Mobile App
Baseline4.0 ± 1.24.5 ± 0.94.4 ± 0.9
Post-treatment3.6 ± 0.73.5 ± 1.23.4 ± 1.1
3-month follow-up3.3 ± 0.93.0 ± 1.03.0 ± 1.3
SecondarySymptom Checklist 90

Participant-reported psychiatry symptoms. Scores range from 0 - 360 (90 5-point Likert items) with higher scores indicating greater symptom severity.

Time frame:
Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
Reported as:
Mean · score on a scale
Symptom Checklist 90
score on a scalePhase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile AppPhase II RCT - Cognitive Behavioral Therapy (CBT)_no AppPhase II RCT - Cognitive Behavioral Therapy (CBT) With Mobile App
Baseline104.4 ± 76.1135.0 ± 72.2106.4 ± 50.8
End of treatment100.3 ± 74.2105.2 ± 85.686.5 ± 66.0
End of study71.0 ± 77.287.6 ± 72.684.2 ± 64.6
SecondaryDifficulties With Emotion Regulation

Participant reported their difficulties with emotion regulation. Scores range from 36 - 180 (36 5-point items) with higher scores indicating greater distress.

Time frame:
Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
Reported as:
Mean · score on a scale
Difficulties With Emotion Regulation
score on a scalePhase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile AppPhase II RCT - Cognitive Behavioral Therapy (CBT)_no AppPhase II RCT - Cognitive Behavioral Therapy (CBT) With Mobile App
Baseline106.0 ± 23.0101.9 ± 28.699.5 ± 18.7
End of treatment103.22 ± 26.897.7 ± 31.590.9 ± 21.7
End of study87.0 ± 26.192.2 ± 28.789.9 ± 17.4
SecondaryKINDL

Quality of life measure. Scores range from 0 - 120 (30 5-point items) with higher scores indicating better quality of life.

Time frame:
Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
Reported as:
Mean · units on a scale
KINDL
units on a scalePhase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile AppPhase II RCT - Cognitive Behavioral Therapy (CBT)_no AppPhase II RCT - Cognitive Behavioral Therapy (CBT) With Mobile App
Baseline105.7 ± 10.990.63 ± 15.295.13 ± 9.97
End of treatment104.4 ± 9.897.3 ± 13.197.5 ± 16.7
End of study109.5 ± 10.7102.3 ± 15.1100 ± 18.2
SecondaryDepression Anxiety & Stress Scale

Parent reported mood, anxiety and stress. Scores range from 0 - 63 (21 4-point items) with higher scores indicating greater distress.

Time frame:
Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
Reported as:
Mean · score on a scale
Depression Anxiety & Stress Scale
score on a scalePhase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile AppPhase II RCT - Cognitive Behavioral Therapy (CBT)_no AppPhase II RCT - Cognitive Behavioral Therapy (CBT) With Mobile App
Baseline20.5 ± 14.912.97 ± 8.011.7 ± 11.3
End of treatment19.2 ± 16.212.5 ± 7.211.5 ± 7.1
End of study15.0 ± 15.811.8 ± 9.711.0 ± 9.3

Adverse events

Collected over 21-weeks (i.e., from enrollment through completion of 21-week study). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App0/31 (0%)0/31 (0%)0/31 (0%)
Phase II RCT - Cognitive Behavioral Therapy (CBT)_no App0/30 (0%)0/30 (0%)0/30 (0%)
Phase II RCT - Cognitive Behavioral Therapy (CBT) With Mobile App0/30 (0%)0/30 (0%)0/30 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile AppPhase II RCT- Cognitive Behavioral Therapy (CBT)_no AppPhase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile AppTotal
<=18 years31303091
Between 18 and 65 years0000
>=65 years0000
Sex: Female, Male
Sex: Female, Male(Participants)Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile AppPhase II RCT- Cognitive Behavioral Therapy (CBT)_no AppPhase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile AppTotal
Female19182158
Male1212933
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile AppPhase II RCT- Cognitive Behavioral Therapy (CBT)_no AppPhase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile AppTotal
American Indian or Alaska Native0000
Asian3317
Native Hawaiian or Other Pacific Islander0000
Black or African American2518
White24192164
More than one race23712
Unknown or Not Reported0000
Depressive mood disorder diagnosis
Depressive mood disorder diagnosis(Participants)Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile AppPhase II RCT- Cognitive Behavioral Therapy (CBT)_no AppPhase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile AppTotal
Number25222572
08

Study locations

1 site
  • UCLA Semel Institute
    Los Angeles, California 90095-8353, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jan 10, 2021

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04887155
Lead sponsor
University of California, Los Angeles
Responsible party
Marc J. Weintraub, PhD (Principal Investigator, University of California, Los Angeles) — Principal investigator
First posted
May 14, 2021
Start date
Aug 30, 2021
Primary completion
Mar 15, 2024
Completion
Mar 15, 2024
Results posted
May 22, 2025
Last update
May 22, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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