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

Sponsor
University of California, Los Angeles (Other)
Overall Status
Recruiting
CT.gov ID
NCT04887155
Collaborator
(none)
12
1
1
12
1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive behavioral therapy (CBT)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Mobile-enhanced Transdiagnostic Group Treatment for Adolescents at Risk for Severe Mood Disorders
Actual Study Start Date :
Aug 30, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cognitive behavioral therapy (CBT)

Behavioral: Cognitive behavioral therapy (CBT)
Group-based transdiagnostic cognitive-behavioral treatment

Outcome Measures

Primary Outcome Measures

  1. Change in weekly participant adherence [3-month study period]

    Clinician-rated based on participant report

  2. Subjective app usability scale [Measured at the end of the 3-month study period]

    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

  3. Psychosocial compliance scale [3-month study period]

    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

  4. Participant app usage [3-month study period]

    Frequency of participants' app usage

Secondary Outcome Measures

  1. Children's Depression Rating Scale, Revised [Measured prior to treatment (0 months) and the end of the three-month study period.]

    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.

  2. Young Mania Rating Scale [Measured prior to treatment (0 months) and the end of the three-month study period.]

    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.

  3. Clinical Global Assessment Scale [Measured prior to treatment (0 months) and the end of the three-month study period.]

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

  4. Clinical Global Impression [Measured prior to treatment (0 months) and the end of the three-month study period.]

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

  5. Symptom Checklist 90 [Measured prior to treatment (0 months) and the end of the three-month study period.]

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

  6. Depression Anxiety & Stress Scale [Measured prior to treatment (0 months) and the end of the three-month study period.]

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

  7. KINDL [Measured prior to treatment (0 months) and the end of the three-month study period.]

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

  8. Depression Anxiety & Stress Scale [Measured prior to treatment (0 months) and the end of the three-month study period.]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 17 Years
Sexes Eligible for Study:
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:
  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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UCLA Semel Institute Los Angeles California United States 90095-8353

Sponsors and Collaborators

  • University of California, Los Angeles

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marc J. Weintraub, PhD, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT04887155
Other Study ID Numbers:
  • 21-000036
First Posted:
May 14, 2021
Last Update Posted:
Jan 31, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marc J. Weintraub, PhD, Principal Investigator, University of California, Los Angeles
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 31, 2022