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Tailored Cognitive Behavioral Therapy App + Standard Therapy for Depression (CBT Mobile-V Trial)
N/A
Waitlist Available
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
No Placebo-Only Group
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.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Skills of Cognitive Therapy (Patient Version) Change
Secondary study objectives
Patient Health Questionnaire (PHQ-9) Change
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
1,663 Previous Clinical Trials
3,765,745 Total Patients Enrolled
78 Trials studying Depression
19,928 Patients Enrolled for Depression
Corporal Michael J. Crescenz VA Medical CenterFED
30 Previous Clinical Trials
10,017 Total Patients Enrolled
Judith Ann Callan, PhD RNPrincipal InvestigatorVA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
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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
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