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Behavioral Intervention

Mobile-Enhanced CBT for Mood Disorders in Adolescents

N/A
Recruiting
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be 13-17 years old
Medication usage is acceptable, but not required
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-month study period
Awards & highlights

Study Summary

This trialtests if a mobile app can help teens at high risk of severe mood disorders (e.g., bipolar) adhere to treatment and improve symptoms.

Who is the study for?
This trial is for English-speaking adolescents aged 13-17 who have had a major depressive episode or unspecified bipolar disorder, can attend group sessions, and use a smartphone app. It's not for those with bipolar I/II, psychosis, severe psychiatric symptoms needing intense treatment, drug abuse issues, behavioral problems affecting group therapy, or high suicidality.Check my eligibility
What is being tested?
The study tests if adding a mobile app to Group Cognitive Behavioral Therapy (CBT) helps teens at risk of severe mood disorders stick to their treatment better. The app includes skill practices and monitoring tools designed to increase engagement and adherence.See study design
What are the potential side effects?
While CBT itself typically doesn't cause physical side effects like medication might, participants may experience emotional discomfort when discussing personal issues during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 13 and 17 years old.
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I may or may not be taking medications.
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I can attend all scheduled group sessions.
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I can speak English and fill out written forms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-month study period
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-month study period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in weekly participant adherence
Participant app usage
Psychosocial compliance scale
+1 more
Secondary outcome measures
Children's Depression Rating Scale, Revised
Clinical Global Assessment Scale
Clinical Global Impression
+4 more

Side effects data

From 2008 Phase 3 trial • 150 Patients • NCT00074802
56%
Decreased Libido
56%
Anorgasmia
56%
Weight Gain
53%
Somnolence
47%
Fatigue
34%
Headache
34%
Nervousness
28%
Lightheadedness
28%
Nasal Congestion
28%
Insomnia
25%
Dry Mouth
22%
Weight Loss
22%
Tremor
19%
Nausea
19%
Urinary Congestion
16%
Palpitations
16%
Constipation
13%
Vomiting
13%
Sweating
13%
Tachycardia
13%
Dermatitis
13%
Diarrhea
13%
Rigidity
9%
Parathesias
9%
Photophobia
9%
Impaired Coordination
6%
Bradycardia
6%
Myalgia
6%
Blurry Vision
100%
80%
60%
40%
20%
0%
Study treatment Arm
Paroxetine With CBT Augmentation
Paroxetine Continuation

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive behavioral therapy (CBT) with mobile appExperimental Treatment1 Intervention
Group II: Cognitive behavioral therapy (CBT)_no appActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive behavioral therapy (CBT)
2002
Completed Phase 3
~2020

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,525 Previous Clinical Trials
10,279,678 Total Patients Enrolled
7 Trials studying Mood Disorders
467 Patients Enrolled for Mood Disorders

Media Library

CBT (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04887155 — N/A
Mood Disorders Research Study Groups: Cognitive behavioral therapy (CBT)_no app, Cognitive behavioral therapy (CBT) with mobile app
Mood Disorders Clinical Trial 2023: CBT Highlights & Side Effects. Trial Name: NCT04887155 — N/A
CBT (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04887155 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age restriction for this trial above 45?

"In accordance with the rules of this trial, each patient must be between 13 and 17 years old."

Answered by AI

With what purpose is this clinical experiment being conducted?

"The primary outcome for this research, monitored over a 3-month period, will be the Change in weekly participant adherence. The secondary measures are: Children's Depression Rating Scale Revised measuring depressive symptom severity across 14 seven-point items and three five-point items (0 to 113); KINDL assessing quality of life using 30 five-point markers (lowest score 0; highest 120), and Symptom Checklist 90 capturing participant reported psychiatric symptoms with 90 Likert item points ranging from zero to 360."

Answered by AI

Are there any criteria needed to be eligible for this trial?

"This clinical trial is offering participation to 60 adolescents, aged 13-17 years old and diagnosed with a depressive or bipolar disorder according to the DSM-5. It is necessary that participants own a smartphone for use in conjunction with the study app, though medication consumption is not mandatory. Furthermore, attendance at prearranged group sessions must be possible."

Answered by AI

How many participants are currently participating in this research project?

"Affirmative. According to clinicaltrials.gov, the research project first posted on August 30th 2021 is currently in need of participants. 60 patients are required for this study at one specific medical facility and it was most recently updated on October 31st 2022."

Answered by AI

Is the enrollment period for this experiment still open?

"As per the data hosted on clinicaltrials.gov, this research is actively seeking volunteers for participation. The trial was initially published on August 30th 2021 and had its last edit made at the end of October 2022."

Answered by AI
~5 spots leftby Jun 2024