Adolescents, Mood Disorders
Conditions
Keywords
cognitive behavioral therapy (CBT), mobile health (mHealth), Group treatment
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.
Interventions
BEHAVIORALCognitive behavioral therapy (CBT)
Group-based transdiagnostic cognitive-behavioral treatment
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Skill Practice | 9-week treatment period | Sum of all treatment skill practices completed through the course of the treatment (based on adolescent report). |
| Psychosocial Treatment Compliance Scale | 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. |
| Mobile Application Use | 9-week treatment period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Assessment Scale | Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period. | Measures overall functioning on a 1-100 scale, with higher scores indicating better functioning. |
| Clinical Global Impression | Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period. | Measures overall clinical functioning from 1-7, with higher scores indicating greater psychiatric severity. |
| Symptom Checklist 90 | Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period. | Participant-reported psychiatry symptoms. Scores range from 0 - 360 (90 5-point Likert items) with higher scores indicating greater symptom severity. |
| Mobile Application Usability Scale | Measured at the end of the 9-week treatment period | Mobile application (app) acceptability as rated on a 5-point scale (i.e., minimum = 1, maximum = 5) with higher values indicating greater acceptability |
| KINDL | Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period. | Quality of life measure. Scores range from 0 - 120 (30 5-point items) with higher scores indicating better quality of life. |
| Depression Anxiety & Stress Scale | Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period. | Parent reported mood, anxiety and stress. Scores range from 0 - 63 (21 4-point items) with higher scores indicating greater distress. |
| Difficulties With Emotion Regulation | Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period. | Participant reported their difficulties with emotion regulation. Scores range from 36 - 180 (36 5-point items) with higher scores indicating greater distress. |
| Children's Depression Rating Scale, Revised | Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week 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. |
| Young Mania Rating Scale | Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week 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. |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
196 youth phone screened Phase I Open Trial: 33 youth assessed 31 youth enrolled Phase II RCT: 66 youth assessed 60 youth enrolled
Participants by arm
| Arm | Count |
|---|---|
| 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. | 31 |
| 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. | 30 |
| 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. | 30 |
| Total | 91 |
Baseline characteristics
| Characteristic | Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | Phase II RCT- Cognitive Behavioral Therapy (CBT)_no App | Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 31 Participants | 30 Participants | 30 Participants | 91 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Depressive mood disorder diagnosis | 25 Participants | 22 Participants | 25 Participants | 72 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 7 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 19 Participants | 21 Participants | 64 Participants |
| Sex: Female, Male Female | 19 Participants | 18 Participants | 21 Participants | 58 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 9 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 31 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 31 | 0 / 30 | 0 / 30 |
Outcome results
Primary
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
Population: No App Condition did not receive the study app
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | Mobile Application Use | 8.8 units on a scale | Standard Deviation 7.5 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | Mobile Application Use | 9.6 units on a scale | Standard Deviation 5 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | Psychosocial Treatment Compliance Scale | 64.6 units on a scale | Standard Deviation 11.2 |
| Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | Psychosocial Treatment Compliance Scale | 66.42 units on a scale | Standard Deviation 10.47 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | Psychosocial Treatment Compliance Scale | 67.83 units on a scale | Standard Deviation 9 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | Treatment Skill Practice | 16.1 treatment skill practices | Standard Deviation 8.8 |
| Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | Treatment Skill Practice | 56.2 treatment skill practices | Standard Deviation 33.6 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | Treatment Skill Practice | 44.3 treatment skill practices | Standard Deviation 43.6 |
Secondary
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.
Population: The number analyzed in one or more rows differs from overall number analyzed due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | Children's Depression Rating Scale, Revised | Post-treatment | 36.3 score on a scale | Standard Deviation 8.5 |
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | Children's Depression Rating Scale, Revised | Baseline | 44.2 score on a scale | Standard Deviation 11.7 |
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | Children's Depression Rating Scale, Revised | 3-month follow-up | 35.9 score on a scale | Standard Deviation 12 |
| Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | Children's Depression Rating Scale, Revised | Post-treatment | 36.8 score on a scale | Standard Deviation 11.8 |
| Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | Children's Depression Rating Scale, Revised | Baseline | 45.7 score on a scale | Standard Deviation 10.4 |
| Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | Children's Depression Rating Scale, Revised | 3-month follow-up | 33.3 score on a scale | Standard Deviation 11.2 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | Children's Depression Rating Scale, Revised | Baseline | 46.2 score on a scale | Standard Deviation 11.6 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | Children's Depression Rating Scale, Revised | 3-month follow-up | 34.4 score on a scale | Standard Deviation 14.2 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | Children's Depression Rating Scale, Revised | Post-treatment | 35.9 score on a scale | Standard Deviation 11.5 |
Secondary
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.
Population: The difference between the analysis population total between rows is due to study participant attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | Clinical Global Assessment Scale | Post-treatment | 65.2 score on a scale | Standard Deviation 7 |
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | Clinical Global Assessment Scale | Baseline | 57.9 score on a scale | Standard Deviation 11.9 |
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | Clinical Global Assessment Scale | 3-month follow-up | 67.8 score on a scale | Standard Deviation 9 |
| Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | Clinical Global Assessment Scale | Post-treatment | 54 score on a scale | Standard Deviation 9.3 |
| Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | Clinical Global Assessment Scale | Baseline | 47.7 score on a scale | Standard Deviation 7.4 |
| Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | Clinical Global Assessment Scale | 3-month follow-up | 61.7 score on a scale | Standard Deviation 14.1 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | Clinical Global Assessment Scale | Baseline | 44.5 score on a scale | Standard Deviation 7.5 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | Clinical Global Assessment Scale | 3-month follow-up | 61.7 score on a scale | Standard Deviation 15.7 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | Clinical Global Assessment Scale | Post-treatment | 58.1 score on a scale | Standard Deviation 9.8 |
Secondary
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.
Population: The difference between the analysis population total between rows is due to study participant attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | Clinical Global Impression | Post-treatment | 3.6 score on a scale | Standard Deviation 0.7 |
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | Clinical Global Impression | Baseline | 4.0 score on a scale | Standard Deviation 1.2 |
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | Clinical Global Impression | 3-month follow-up | 3.3 score on a scale | Standard Deviation 0.9 |
| Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | Clinical Global Impression | Post-treatment | 3.5 score on a scale | Standard Deviation 1.2 |
| Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | Clinical Global Impression | Baseline | 4.5 score on a scale | Standard Deviation 0.9 |
| Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | Clinical Global Impression | 3-month follow-up | 3.0 score on a scale | Standard Deviation 1 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | Clinical Global Impression | Baseline | 4.4 score on a scale | Standard Deviation 0.9 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | Clinical Global Impression | 3-month follow-up | 3.0 score on a scale | Standard Deviation 1.3 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | Clinical Global Impression | Post-treatment | 3.4 score on a scale | Standard Deviation 1.1 |
Secondary
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.
Population: The difference between the analysis population totals between rows is due to participant attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | Depression Anxiety & Stress Scale | End of treatment | 19.2 score on a scale | Standard Deviation 16.2 |
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | Depression Anxiety & Stress Scale | Baseline | 20.5 score on a scale | Standard Deviation 14.9 |
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | Depression Anxiety & Stress Scale | End of study | 15.0 score on a scale | Standard Deviation 15.8 |
| Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | Depression Anxiety & Stress Scale | End of treatment | 12.5 score on a scale | Standard Deviation 7.2 |
| Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | Depression Anxiety & Stress Scale | Baseline | 12.97 score on a scale | Standard Deviation 8 |
| Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | Depression Anxiety & Stress Scale | End of study | 11.8 score on a scale | Standard Deviation 9.7 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | Depression Anxiety & Stress Scale | Baseline | 11.7 score on a scale | Standard Deviation 11.3 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | Depression Anxiety & Stress Scale | End of study | 11.0 score on a scale | Standard Deviation 9.3 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | Depression Anxiety & Stress Scale | End of treatment | 11.5 score on a scale | Standard Deviation 7.1 |
Secondary
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.
Population: The difference between the analysis population total between rows is due to study participant attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | Difficulties With Emotion Regulation | End of treatment | 103.22 score on a scale | Standard Deviation 26.8 |
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | Difficulties With Emotion Regulation | Baseline | 106.0 score on a scale | Standard Deviation 23 |
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | Difficulties With Emotion Regulation | End of study | 87.0 score on a scale | Standard Deviation 26.1 |
| Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | Difficulties With Emotion Regulation | End of treatment | 97.7 score on a scale | Standard Deviation 31.5 |
| Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | Difficulties With Emotion Regulation | Baseline | 101.9 score on a scale | Standard Deviation 28.6 |
| Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | Difficulties With Emotion Regulation | End of study | 92.2 score on a scale | Standard Deviation 28.7 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | Difficulties With Emotion Regulation | Baseline | 99.5 score on a scale | Standard Deviation 18.7 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | Difficulties With Emotion Regulation | End of study | 89.9 score on a scale | Standard Deviation 17.4 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | Difficulties With Emotion Regulation | End of treatment | 90.9 score on a scale | Standard Deviation 21.7 |
Secondary
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.
Population: The difference between the analysis population total between rows is due to study participant attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | KINDL | End of study | 109.5 units on a scale | Standard Deviation 10.7 |
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | KINDL | Baseline | 105.7 units on a scale | Standard Deviation 10.9 |
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | KINDL | End of treatment | 104.4 units on a scale | Standard Deviation 9.8 |
| Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | KINDL | Baseline | 90.63 units on a scale | Standard Deviation 15.2 |
| Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | KINDL | End of treatment | 97.3 units on a scale | Standard Deviation 13.1 |
| Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | KINDL | End of study | 102.3 units on a scale | Standard Deviation 15.1 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | KINDL | End of treatment | 97.5 units on a scale | Standard Deviation 16.7 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | KINDL | End of study | 100 units on a scale | Standard Deviation 18.2 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | KINDL | Baseline | 95.13 units on a scale | Standard Deviation 9.97 |
Secondary
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
Population: No App condition did not receive the study app
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | Mobile Application Usability Scale | 3.9 units on a scale | Standard Deviation 1.3 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | Mobile Application Usability Scale | 4.3 units on a scale | Standard Deviation 0.8 |
Secondary
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.
Population: The difference between the analysis population total between rows is due to study participant attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | Symptom Checklist 90 | End of study | 71.0 score on a scale | Standard Deviation 77.2 |
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | Symptom Checklist 90 | End of treatment | 100.3 score on a scale | Standard Deviation 74.2 |
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | Symptom Checklist 90 | Baseline | 104.4 score on a scale | Standard Deviation 76.1 |
| Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | Symptom Checklist 90 | End of study | 87.6 score on a scale | Standard Deviation 72.6 |
| Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | Symptom Checklist 90 | Baseline | 135.0 score on a scale | Standard Deviation 72.2 |
| Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | Symptom Checklist 90 | End of treatment | 105.2 score on a scale | Standard Deviation 85.6 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | Symptom Checklist 90 | End of treatment | 86.5 score on a scale | Standard Deviation 66 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | Symptom Checklist 90 | Baseline | 106.4 score on a scale | Standard Deviation 50.8 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | Symptom Checklist 90 | End of study | 84.2 score on a scale | Standard Deviation 64.6 |
Secondary
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.
Population: The difference between the analysis population total between rows is due to study participant attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | Young Mania Rating Scale | Post-treatment | 9.2 score on a scale | Standard Deviation 5.3 |
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | Young Mania Rating Scale | Baseline | 10.1 score on a scale | Standard Deviation 6.1 |
| Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | Young Mania Rating Scale | 3-month follow-up | 7.9 score on a scale | Standard Deviation 5.2 |
| Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | Young Mania Rating Scale | Post-treatment | 7.3 score on a scale | Standard Deviation 5.1 |
| Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | Young Mania Rating Scale | Baseline | 10.3 score on a scale | Standard Deviation 5.2 |
| Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | Young Mania Rating Scale | 3-month follow-up | 6.9 score on a scale | Standard Deviation 5.8 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | Young Mania Rating Scale | Baseline | 9.6 score on a scale | Standard Deviation 5.1 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | Young Mania Rating Scale | 3-month follow-up | 6.7 score on a scale | Standard Deviation 4.1 |
| Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | Young Mania Rating Scale | Post-treatment | 6.0 score on a scale | Standard Deviation 4.2 |