Trial Outcomes & Findings for Mobile-enhanced Group CBT for Adolescents at Risk Severe Mood Disorders (NCT NCT04887155)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

91 participants

Primary outcome timeframe

9-week treatment period

Results posted on

2025-05-22

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

196 youth phone screened Phase I Open Trial: 33 youth assessed 31 youth enrolled Phase II RCT: 66 youth assessed 60 youth enrolled

Participant milestones

Participant milestones
Measure	Phase I Open Trial-Cognitive Behavioral Therapy (CBT) With Mobile App The treatment delivered in this study is a modified version of the Unified Protocol (UP) for Adolescents, a CBT protocol for adolescents with emotional disorders. The treatment included nine, 90-minute weekly group sessions delivered in three modules - psychoeducation, behavioral skills, and cognitive skills. Participants in this conditions were also provided with access to a mobile application. The app was designed to help adolescents accomplish three treatment tasks: (1) review the treatment session content, (2) practice treatment skills, (3) and review and log their psychiatric symptoms and functional status (also known as the symptom check-in). Participants were able to review their treatment skill practice and track their symptoms in a section of the app called 'Review My Progress.' The app was used as a direct tool in the therapy session, as it was used by clinicians to review the treatment materials and have the participants practice the treatment skills in sessions. Additionally, the app served as a method to bridge sessions by allowing participants to review the prior session's content and practice treatment skills from their mobile device. The app also contained three primary engagement features: 1) text reminders to conduct weekly skill practice and symptom logging, 2) emojis that were earned upon completion of the weekly treatment skill practice, and 3) a skills streak counter indicating the consecutive weeks the participant has completed their skill practices.	Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App The treatment delivered in this study is a modified version of the Unified Protocol (UP) for Adolescents, a CBT protocol for adolescents with emotional disorders. The treatment included nine, 90-minute weekly group sessions delivered in three modules - psychoeducation, behavioral skills, and cognitive skills.	Phase II RCT - Cognitive Behavioral Therapy (CBT) With Mobile App The treatment delivered in this study is a modified version of the Unified Protocol (UP) for Adolescents, a CBT protocol for adolescents with emotional disorders. The treatment included nine, 90-minute weekly group sessions delivered in three modules - psychoeducation, behavioral skills, and cognitive skills. Participants in this conditions were also provided with access to a mobile application. The app was designed to help adolescents accomplish three treatment tasks: (1) review the treatment session content, (2) practice treatment skills, (3) and review and log their psychiatric symptoms and functional status (also known as the symptom check-in). Participants were able to review their treatment skill practice and track their symptoms in a section of the app called 'Review My Progress.' The app was used as a direct tool in the therapy session, as it was used by clinicians to review the treatment materials and have the participants practice the treatment skills in sessions. Additionally, the app served as a method to bridge sessions by allowing participants to review the prior session's content and practice treatment skills from their mobile device. The app also contained three primary engagement features: 1) text reminders to conduct weekly skill practice and symptom logging, 2) emojis that were earned upon completion of the weekly treatment skill practice, and 3) a skills streak counter indicating the consecutive weeks the participant has completed their skill practices.
Overall Study STARTED	31	30	30
Overall Study COMPLETED	24	25	24
Overall Study NOT COMPLETED	7	5	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App n=31 Participants The treatment delivered in this study is a modified version of the Unified Protocol (UP) for Adolescents, a CBT protocol for adolescents with emotional disorders. The treatment included nine, 90-minute weekly group sessions delivered in three modules - psychoeducation, behavioral skills, and cognitive skills. Participants in this conditions were also provided with access to a mobile application. The app was designed to help adolescents accomplish three treatment tasks: (1) review the treatment session content, (2) practice treatment skills, (3) and review and log their psychiatric symptoms and functional status (also known as the symptom check-in). Participants were able to review their treatment skill practice and track their symptoms in a section of the app called 'Review My Progress.' The app was used as a direct tool in the therapy session, as it was used by clinicians to review the treatment materials and have the participants practice the treatment skills in sessions. Additionally, the app served as a method to bridge sessions by allowing participants to review the prior session's content and practice treatment skills from their mobile device. The app also contained three primary engagement features: 1) text reminders to conduct weekly skill practice and symptom logging, 2) emojis that were earned upon completion of the weekly treatment skill practice, and 3) a skills streak counter indicating the consecutive weeks the participant has completed their skill practices.	Phase II RCT- Cognitive Behavioral Therapy (CBT)_no App n=30 Participants The treatment delivered in this study is a modified version of the Unified Protocol (UP) for Adolescents, a CBT protocol for adolescents with emotional disorders. The treatment included nine, 90-minute weekly group sessions delivered in three modules - psychoeducation, behavioral skills, and cognitive skills.	Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App n=30 Participants The treatment delivered in this study is a modified version of the Unified Protocol (UP) for Adolescents, a CBT protocol for adolescents with emotional disorders. The treatment included nine, 90-minute weekly group sessions delivered in three modules - psychoeducation, behavioral skills, and cognitive skills. Participants in this conditions were also provided with access to a mobile application. The app was designed to help adolescents accomplish three treatment tasks: (1) review the treatment session content, (2) practice treatment skills, (3) and review and log their psychiatric symptoms and functional status (also known as the symptom check-in). Participants were able to review their treatment skill practice and track their symptoms in a section of the app called 'Review My Progress.' The app was used as a direct tool in the therapy session, as it was used by clinicians to review the treatment materials and have the participants practice the treatment skills in sessions. Additionally, the app served as a method to bridge sessions by allowing participants to review the prior session's content and practice treatment skills from their mobile device. The app also contained three primary engagement features: 1) text reminders to conduct weekly skill practice and symptom logging, 2) emojis that were earned upon completion of the weekly treatment skill practice, and 3) a skills streak counter indicating the consecutive weeks the participant has completed their skill practices.	Total n=91 Participants Total of all reporting groups
Age, Categorical <=18 years	31 Participants n=93 Participants	30 Participants n=4 Participants	30 Participants n=27 Participants	91 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Sex: Female, Male Female	19 Participants n=93 Participants	18 Participants n=4 Participants	21 Participants n=27 Participants	58 Participants n=483 Participants
Sex: Female, Male Male	12 Participants n=93 Participants	12 Participants n=4 Participants	9 Participants n=27 Participants	33 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants	3 Participants n=4 Participants	1 Participants n=27 Participants	7 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	5 Participants n=4 Participants	1 Participants n=27 Participants	8 Participants n=483 Participants
Race (NIH/OMB) White	24 Participants n=93 Participants	19 Participants n=4 Participants	21 Participants n=27 Participants	64 Participants n=483 Participants
Race (NIH/OMB) More than one race	2 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants	12 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Depressive mood disorder diagnosis	25 Participants n=93 Participants	22 Participants n=4 Participants	25 Participants n=27 Participants	72 Participants n=483 Participants

PRIMARY outcome

Timeframe: 9-week treatment period

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

Outcome measures

Outcome measures
Measure	Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App n=24 Participants The treatment delivered in this study is a modified version of the Unified Protocol (UP) for Adolescents, a CBT protocol for adolescents with emotional disorders. The treatment included nine, 90-minute weekly group sessions delivered in three modules - psychoeducation, behavioral skills, and cognitive skills. Participants in this conditions were also provided with access to a mobile application. The app was designed to help adolescents accomplish three treatment tasks: (1) review the treatment session content, (2) practice treatment skills, (3) and review and log their psychiatric symptoms and functional status (also known as the symptom check-in). Participants were able to review their treatment skill practice and track their symptoms in a section of the app called 'Review My Progress.' The app was used as a direct tool in the therapy session, as it was used by clinicians to review the treatment materials and have the participants practice the treatment skills in sessions. Additionally, the app served as a method to bridge sessions by allowing participants to review the prior session's content and practice treatment skills from their mobile device. The app also contained three primary engagement features: 1) text reminders to conduct weekly skill practice and symptom logging, 2) emojis that were earned upon completion of the weekly treatment skill practice, and 3) a skills streak counter indicating the consecutive weeks the participant has completed their skill practices.	Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App n=24 Participants The treatment delivered in this study is a modified version of the Unified Protocol (UP) for Adolescents, a CBT protocol for adolescents with emotional disorders. The treatment included nine, 90-minute weekly group sessions delivered in three modules - psychoeducation, behavioral skills, and cognitive skills.	Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App n=25 Participants The treatment delivered in this study is a modified version of the Unified Protocol (UP) for Adolescents, a CBT protocol for adolescents with emotional disorders. The treatment included nine, 90-minute weekly group sessions delivered in three modules - psychoeducation, behavioral skills, and cognitive skills. Participants in this conditions were also provided with access to a mobile application. The app was designed to help adolescents accomplish three treatment tasks: (1) review the treatment session content, (2) practice treatment skills, (3) and review and log their psychiatric symptoms and functional status (also known as the symptom check-in). Participants were able to review their treatment skill practice and track their symptoms in a section of the app called 'Review My Progress.' The app was used as a direct tool in the therapy session, as it was used by clinicians to review the treatment materials and have the participants practice the treatment skills in sessions. Additionally, the app served as a method to bridge sessions by allowing participants to review the prior session's content and practice treatment skills from their mobile device. The app also contained three primary engagement features: 1) text reminders to conduct weekly skill practice and symptom logging, 2) emojis that were earned upon completion of the weekly treatment skill practice, and 3) a skills streak counter indicating the consecutive weeks the participant has completed their skill practices.
Treatment Skill Practice	16.1 treatment skill practices Standard Deviation 8.8	56.2 treatment skill practices Standard Deviation 33.6	44.3 treatment skill practices Standard Deviation 43.6

PRIMARY outcome

Timeframe: 9-week treatment

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.

Outcome measures

Outcome measures
Measure	Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App n=24 Participants The treatment delivered in this study is a modified version of the Unified Protocol (UP) for Adolescents, a CBT protocol for adolescents with emotional disorders. The treatment included nine, 90-minute weekly group sessions delivered in three modules - psychoeducation, behavioral skills, and cognitive skills. Participants in this conditions were also provided with access to a mobile application. The app was designed to help adolescents accomplish three treatment tasks: (1) review the treatment session content, (2) practice treatment skills, (3) and review and log their psychiatric symptoms and functional status (also known as the symptom check-in). Participants were able to review their treatment skill practice and track their symptoms in a section of the app called 'Review My Progress.' The app was used as a direct tool in the therapy session, as it was used by clinicians to review the treatment materials and have the participants practice the treatment skills in sessions. Additionally, the app served as a method to bridge sessions by allowing participants to review the prior session's content and practice treatment skills from their mobile device. The app also contained three primary engagement features: 1) text reminders to conduct weekly skill practice and symptom logging, 2) emojis that were earned upon completion of the weekly treatment skill practice, and 3) a skills streak counter indicating the consecutive weeks the participant has completed their skill practices.	Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App n=24 Participants The treatment delivered in this study is a modified version of the Unified Protocol (UP) for Adolescents, a CBT protocol for adolescents with emotional disorders. The treatment included nine, 90-minute weekly group sessions delivered in three modules - psychoeducation, behavioral skills, and cognitive skills.	Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App n=25 Participants The treatment delivered in this study is a modified version of the Unified Protocol (UP) for Adolescents, a CBT protocol for adolescents with emotional disorders. The treatment included nine, 90-minute weekly group sessions delivered in three modules - psychoeducation, behavioral skills, and cognitive skills. Participants in this conditions were also provided with access to a mobile application. The app was designed to help adolescents accomplish three treatment tasks: (1) review the treatment session content, (2) practice treatment skills, (3) and review and log their psychiatric symptoms and functional status (also known as the symptom check-in). Participants were able to review their treatment skill practice and track their symptoms in a section of the app called 'Review My Progress.' The app was used as a direct tool in the therapy session, as it was used by clinicians to review the treatment materials and have the participants practice the treatment skills in sessions. Additionally, the app served as a method to bridge sessions by allowing participants to review the prior session's content and practice treatment skills from their mobile device. The app also contained three primary engagement features: 1) text reminders to conduct weekly skill practice and symptom logging, 2) emojis that were earned upon completion of the weekly treatment skill practice, and 3) a skills streak counter indicating the consecutive weeks the participant has completed their skill practices.
Psychosocial Treatment Compliance Scale	64.6 units on a scale Standard Deviation 11.2	66.42 units on a scale Standard Deviation 10.47	67.83 units on a scale Standard Deviation 9.0

PRIMARY outcome

Timeframe: 9-week treatment period

Population: No App Condition did not receive the study app

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.

Outcome measures

Outcome measures
Measure	Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App n=24 Participants The treatment delivered in this study is a modified version of the Unified Protocol (UP) for Adolescents, a CBT protocol for adolescents with emotional disorders. The treatment included nine, 90-minute weekly group sessions delivered in three modules - psychoeducation, behavioral skills, and cognitive skills. Participants in this conditions were also provided with access to a mobile application. The app was designed to help adolescents accomplish three treatment tasks: (1) review the treatment session content, (2) practice treatment skills, (3) and review and log their psychiatric symptoms and functional status (also known as the symptom check-in). Participants were able to review their treatment skill practice and track their symptoms in a section of the app called 'Review My Progress.' The app was used as a direct tool in the therapy session, as it was used by clinicians to review the treatment materials and have the participants practice the treatment skills in sessions. Additionally, the app served as a method to bridge sessions by allowing participants to review the prior session's content and practice treatment skills from their mobile device. The app also contained three primary engagement features: 1) text reminders to conduct weekly skill practice and symptom logging, 2) emojis that were earned upon completion of the weekly treatment skill practice, and 3) a skills streak counter indicating the consecutive weeks the participant has completed their skill practices.	Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App The treatment delivered in this study is a modified version of the Unified Protocol (UP) for Adolescents, a CBT protocol for adolescents with emotional disorders. The treatment included nine, 90-minute weekly group sessions delivered in three modules - psychoeducation, behavioral skills, and cognitive skills.	Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App n=25 Participants The treatment delivered in this study is a modified version of the Unified Protocol (UP) for Adolescents, a CBT protocol for adolescents with emotional disorders. The treatment included nine, 90-minute weekly group sessions delivered in three modules - psychoeducation, behavioral skills, and cognitive skills. Participants in this conditions were also provided with access to a mobile application. The app was designed to help adolescents accomplish three treatment tasks: (1) review the treatment session content, (2) practice treatment skills, (3) and review and log their psychiatric symptoms and functional status (also known as the symptom check-in). Participants were able to review their treatment skill practice and track their symptoms in a section of the app called 'Review My Progress.' The app was used as a direct tool in the therapy session, as it was used by clinicians to review the treatment materials and have the participants practice the treatment skills in sessions. Additionally, the app served as a method to bridge sessions by allowing participants to review the prior session's content and practice treatment skills from their mobile device. The app also contained three primary engagement features: 1) text reminders to conduct weekly skill practice and symptom logging, 2) emojis that were earned upon completion of the weekly treatment skill practice, and 3) a skills streak counter indicating the consecutive weeks the participant has completed their skill practices.
Mobile Application Use	8.8 units on a scale Standard Deviation 7.5	—	9.6 units on a scale Standard Deviation 5.0

SECONDARY outcome

Timeframe: Measured at the end of the 9-week treatment period

Population: No App condition did not receive the study app

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