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Tailored Cognitive Behavioral Therapy App + Standard Therapy for Depression (CBT Mobile-V Trial)
N/A
Recruiting
Led By Judith Ann Callan, PhD RN
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12, and month 9
Awards & highlights
CBT Mobile-V Trial Summary
This trial is testing whether a smartphone app can help with depression in veterans.
Who is the study for?
This trial is for OEF/OIF/OND Veterans with depression who can read at an eighth-grade level and consent to the study. They must score at least 10 on the PHQ-9, may have certain other mental health conditions or be on stable medication doses, and need to own an Android smartphone.Check my eligibility
What is being tested?
The study tests if adding a mobile app called CBT MobileWork-V that teaches Cognitive Behavioral Therapy (CBT) skills improves depression treatment outcomes compared to standard CBT alone in veterans.See study design
What are the potential side effects?
While not explicitly listed, side effects might include discomfort from confronting personal issues during therapy sessions and potential stress from regular use of the mobile application.
CBT Mobile-V Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 12, and month 9
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12, and month 9
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Skills of Cognitive Therapy (Patient Version) Change
Secondary outcome measures
Patient Health Questionnaire (PHQ-9) Change
CBT Mobile-V Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CBT-D augmented with CBT MobileWork-VExperimental Treatment1 Intervention
Patients randomized to this condition will receive CBT-D as usual plus access to CBT MobileWork-V, a comprehensive tailored smartphone app for CBT skills practice for OEF/OIF Veterans.
Group II: CBT-DActive Control2 Interventions
Patients randomized to CBT-D will receive CBT-D as usual only.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,016 Total Patients Enrolled
76 Trials studying Depression
20,421 Patients Enrolled for Depression
Corporal Michael J. Crescenz VA Medical CenterFED
30 Previous Clinical Trials
10,248 Total Patients Enrolled
Judith Ann Callan, PhD RNPrincipal InvestigatorVA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are a military veteran who served in Operation Enduring Freedom, Operation Iraqi Freedom, or Operation New Dawn deployments.You have expressed serious thoughts or intentions of harming yourself.You feel very sad and hopeless, and may have been diagnosed with depression, anxiety, or substance abuse by a doctor.You have a serious addiction to drugs or alcohol according to DSM-5 criteria.My antidepressant or antianxiety medication dose has been stable for 4 weeks.You need to have an Android smartphone.I have been diagnosed with a psychotic disorder such as schizophrenia or bipolar.
Research Study Groups:
This trial has the following groups:- Group 1: CBT-D augmented with CBT MobileWork-V
- Group 2: CBT-D
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT04002063 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are engaging in this trial?
"Affirmative. The data found on clinicaltrials.gov confirms that this research, which was initially posted October 10th 2022, is actively recruiting participants. A total of 268 individuals must be recruited from 2 specified sites to complete the trial."
Answered by AI
Are individuals fifty years of age and above eligible to participate in the trial?
"This research study has a fairly broad age range, accepting any patient aged between 18 and 70. On the other hand, there are 192 clinical trials for minors and 964 for geriatric patients."
Answered by AI
Are new test subjects actively being sought for this trial?
"Clinicaltrials.gov verifies that this clinical trial is presently recruiting participants, with the initial posting date of October 10th 2022 and most recent update occurring on October 12th 2022."
Answered by AI
Do I meet the criteria to enroll in this research project?
"This clinical study is looking for 268 individuals aged between 18 and 70 years with depression. Qualified candidates must have achieved 8th grade reading level; provide informed consent; be a veteran of OEF/OIF/OND deployments; display depressive severity 10+ on the PHQ-9 scale (DSM-5 56 unipolar Major Depression, PTSD, anxiety disorder, substance or alcohol abuse, or adjustment disorder); consume stable doses of antidepressants and antianxiety medication 4 weeks prior to screening evaluation; possess an Android phone device and agree to audio recording during treatment sessions."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Pennsylvania
New York
Other
How old are they?
65+
18 - 65
What site did they apply to?
Other
Washington DC VA Medical Center, Washington, DC
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
Therapy seems to help me the most and I am interested to see how beneficial this can be.
PatientReceived 2+ prior treatments
Have struggled with depressive episodes and have been on various medications for the last several years. I feel as though I have a black cloud hanging over me most of the time. Some days it fades away and other days it comes back. I was diagnosed with major depression.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How many screening visits are needed?
PatientReceived 2+ prior treatments
How responsive is this trial?
Most responsive sites:
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA: < 24 hours
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA: < 24 hours
Typically responds via
Email
Average response time
- < 1 Day
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