AdolescentsNCT04887155
Mobile-enhanced Group CBT for Adolescents at Risk Severe Mood Disorders
A study testing Cognitive behavioral therapy (CBT) in people with Adolescents and Mood Disorders, run by University of California, Los Angeles at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Adolescents, Mood Disorders
- What is being tested?
- Cognitive behavioral therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2021to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Semel Institute
Los Angeles, California, 90095-8353
About this study
Official title: Mobile-enhanced Transdiagnostic Group Treatment for Adolescents at Risk for Severe Mood Disorders
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.
- Conditions
- Adolescents, Mood Disorders
- Being tested
- Cognitive behavioral therapy (CBT)
- Keywords
- cognitive behavioral therapy (CBT), mobile health (mHealth), Group treatment
- Medical subject headings
- Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy (CBT)Behavioural
Group-based transdiagnostic cognitive-behavioral treatment
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral therapy (CBT)_no app | Active comparator | Not described Receives: Behavioral: Cognitive behavioral therapy (CBT) |
| Cognitive behavioral therapy (CBT) with mobile app | Experimental | Not described Receives: Behavioral: Cognitive behavioral therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Skill Practice
Sum of all treatment skill practices completed through the course of the treatment (based on adolescent report).
Measured: 9-week treatment period
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.
Measured: 9-week treatment
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.
Measured: 9-week treatment period
Secondary outcomes (9)
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
Measured: Measured at the end of the 9-week treatment period
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.
Measured: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
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.
Measured: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
Clinical Global Assessment Scale
Measures overall functioning on a 1-100 scale, with higher scores indicating better functioning.
Measured: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
Clinical Global Impression
Measures overall clinical functioning from 1-7, with higher scores indicating greater psychiatric severity.
Measured: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
Symptom Checklist 90
Participant-reported psychiatry symptoms. Scores range from 0 - 360 (90 5-point Likert items) with higher scores indicating greater symptom severity.
Measured: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
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.
Measured: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
KINDL
Quality of life measure. Scores range from 0 - 120 (30 5-point items) with higher scores indicating better quality of life.
Measured: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
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.
Measured: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start30 Aug 2021
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AdolescentsStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc J. Weintraub, PhD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887155
- Sponsor's protocol ID
- 21-000036
- Status last verified
- May 2025
- First submitted
- 4 May 2021
- Last updated
- 22 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Weintraub MJ, Ichinose MC, Zinberg JL, Salimian A, Brown RD, Morgan-Fleming G, Gamarra JM, Tran T, Miklowitz DJ. A randomized trial of an app-enhanced group cognitive behavioral therapy for adolescents with mood or psychotic spectrum disorders. J Consult Clin Psychol. 2025 Mar;93(3):131-143. doi: 10.1037/ccp0000946.
PubMed 40014504
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile-enhanced Transdiagnostic Group Treatment for Adolescents at Risk for Severe Mood Disorders
- ClinicalTrials.gov ID
- NCT04887155
- Acronym / sponsor ID
- 21-000036
- Conditions
- Adolescents, Mood Disorders
- Keywords
- cognitive behavioral therapy (CBT), mobile health (mHealth), Group treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 14 May 2021 (actual)
- Results
- Posted 22 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy (CBT)_no app | Active comparator | Behavioral: Cognitive behavioral therapy (CBT) |
| Cognitive behavioral therapy (CBT) with mobile app | Experimental | Behavioral: Cognitive behavioral therapy (CBT) |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral therapy (CBT)Group-based transdiagnostic cognitive-behavioral treatment | Behavioural | Cognitive behavioral therapy (CBT) with mobile app, Cognitive behavioral therapy (CBT)_no app |
Primary outcome
Treatment Skill Practice
Time frame: 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
Time frame: 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
Time frame: 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.
9 secondary outcomes
Mobile Application Usability Scale
Time frame: Measured at the end of the 9-week treatment period
Children's Depression Rating Scale, Revised
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.
Young Mania Rating Scale
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.
Clinical Global Assessment Scale
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.
Clinical Global Impression
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.
Symptom Checklist 90
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.
Difficulties With Emotion Regulation
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.
KINDL
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.
Depression Anxiety & Stress Scale
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40014504Weintraub MJ, Ichinose MC, Zinberg JL, Salimian A, Brown RD, Morgan-Fleming G, Gamarra JM, Tran T, Miklowitz DJ. A randomized trial of an app-enhanced group cognitive behavioral therapy for adolescents with mood or psychotic spectrum disorders. J Consult Clin Psychol. 2025 Mar;93(3):131-143. doi: 10.1037/ccp0000946.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy (CBT) in people with Adolescents and Mood Disorders, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Skill Practice (time frame: 9-week treatment period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04887155, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.