Cognitive behavioral therapy (CBT) for Mood Disorders

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UCLA Semel Institute, Los Angeles, CAMood Disorders+1 MoreCognitive behavioral therapy (CBT) - Behavioral
Eligibility
13 - 17
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Mood Disorders
  • Adolescence

Treatment Effectiveness

Study Objectives

4 Primary · 7 Secondary · Reporting Duration: 3-month study period

3-month study period
Change in weekly participant adherence
Participant app usage
Psychosocial compliance scale
Measured at the end of the 3-month study period
Subjective app usability scale
Month 0
Children's Depression Rating Scale, Revised
Clinical Global Assessment Scale
Clinical Global Impression
Depression Anxiety & Stress Scale
KINDL
Symptom Checklist 90
Young Mania Rating Scale

Trial Safety

Side Effects for

Paroxetine Continuation
69%Anorgasmia
66%Weight Gain
55%Decreased Libido
55%Somnolence
52%Lightheadedness
52%Constipation
48%Fatigue
48%Nervousness
45%Dry Mouth
41%Sweating
38%Nausea
38%Headache
34%Insomnia
34%Myalgia
34%Palpitations
28%Tachycardia
24%Rigidity
24%Nasal Congestion
21%Dermatitis
21%Urinary Congestion
17%Tremor
17%Weight Loss
14%Vomiting
14%Diarrhea
14%Photophobia
14%Blurry Vision
10%Parathesias
10%Impaired Coordination
7%Bradycardia
3%Heavy menstrual bleeding
This histogram enumerates side effects from a completed 2008 Phase 3 trial (NCT00074802) in the Paroxetine Continuation ARM group. Side effects include: Anorgasmia with 69%, Weight Gain with 66%, Decreased Libido with 55%, Somnolence with 55%, Lightheadedness with 52%.

Trial Design

3 Treatment Groups

Cognitive behavioral therapy (CBT)_no app
1 of 3
Cognitive behavioral therapy (CBT)
1 of 3
Cognitive behavioral therapy (CBT) with mobile app
1 of 3

Active Control

Experimental Treatment

60 Total Participants · 3 Treatment Groups

Primary Treatment: Cognitive behavioral therapy (CBT) · No Placebo Group · N/A

Cognitive behavioral therapy (CBT)
Behavioral
Experimental Group · 1 Intervention: Cognitive behavioral therapy (CBT) · Intervention Types: Behavioral
Cognitive behavioral therapy (CBT) with mobile app
Behavioral
Experimental Group · 1 Intervention: Cognitive behavioral therapy (CBT) · Intervention Types: Behavioral
Cognitive behavioral therapy (CBT)_no app
Behavioral
ActiveComparator Group · 1 Intervention: Cognitive behavioral therapy (CBT) · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive behavioral therapy (CBT)
2002
Completed Phase 3
~2020

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3-month study period

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,420 Previous Clinical Trials
6,748,786 Total Patients Enrolled
7 Trials studying Mood Disorders
467 Patients Enrolled for Mood Disorders

Eligibility Criteria

Age 13 - 17 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with a major depressive disorder or a bipolar disorder in the past.
You don't have to take any medication to participate, but it's okay if you do.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.