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

Primary Purpose

Adolescents, Mood Disorders

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cognitive behavioral therapy (CBT)

About this trial

This is an interventional treatment trial for Adolescents focused on measuring cognitive behavioral therapy (CBT), mobile health (mHealth), Group treatment

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UCLA Semel InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cognitive behavioral therapy (CBT)_no app

Cognitive behavioral therapy (CBT) with mobile app

Arm Description

Outcomes

Primary Outcome Measures

Change in weekly participant adherence

Clinician-rated based on participant report

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

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

Participant app usage

Frequency of participants' app usage

Secondary Outcome Measures

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.

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.

Clinical Global Assessment Scale

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

Clinical Global Impression

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

Symptom Checklist 90

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

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.

KINDL

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

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.

Full Information

NCT ID

NCT04887155

First Posted

May 4, 2021

Last Updated

January 4, 2023

Sponsor

University of California, Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT04887155

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 30, 2021 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adolescents, Mood Disorders

Keywords

cognitive behavioral therapy (CBT), mobile health (mHealth), Group treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cognitive behavioral therapy (CBT)_no app

Arm Type

Active Comparator

Arm Title

Cognitive behavioral therapy (CBT) with mobile app

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Cognitive behavioral therapy (CBT)

Intervention Description

Group-based transdiagnostic cognitive-behavioral treatment

Primary Outcome Measure Information:

Title

Change in weekly participant adherence

Description

Clinician-rated based on participant report

Time Frame

3-month study period

Title

Subjective app usability scale

Description

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

Time Frame

Measured at the end of the 3-month study period

Title

Psychosocial compliance scale

Description

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

3-month study period

Title

Participant app usage

Description

Frequency of participants' app usage

Time Frame

3-month study period

Secondary Outcome Measure Information:

Title

Children's Depression Rating Scale, Revised

Description

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