Depression Clinical Trial
— CBT Mobile-VOfficial title:
Does Adding a Tailored Cognitive Behavioral Therapy (CBT) Mobile Skills App Mediate Higher Rates of Depression Recovery, Adjustment, and Quality of Life inOEF/OIF Veterans Compared to Standard CBT?
Depression is a common psychological disorder seen in 18.5% of Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans. Improving the rate of depression recovery and remission is vital to enhance OEF/OIF/OND Veteran's ability to improve work and home adjustment and overall quality of life. OEF/OIF/OND Veterans have reported many barriers to following through with Cognitive therapy skills practice assignments, a key component of CBT therapy, the leading therapy for depression in the VA. Smartphone apps have been identified as a useful widely-used tool to improve the effectiveness of psychological treatments. The investigators propose a full-scale multi-site randomized clinical trial (RCT) to measure the efficacy of CBT-D enhanced with CBT MobileWork-V, a comprehensive CBT skill training smartphone app (the experimental arm) for improving CBT understanding and skill acquisition and depressive symptoms, in OEF/OIF Veterans with depression compared to standard CBT-D.
Status | Recruiting |
Enrollment | 268 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Veteran of OEF/OIF/OND deployments - Depressive severity of at least 10 on the PHQ-9 at screening (Patient may also have a DSM-5 56 diagnosis of unipolar Major Depression; PTSD; any anxiety disorder; substance/alcohol abuse; or adjustment disorder) - Ability to read at the eighth grade level and to provide informed consent - Patients may be taking antidepressants or antianxiety medications where dose has been stable for at least 4 weeks prior to screening evaluation - Must have an Android smartphone - Must be willing to be audio-taped for fidelity ratings Exclusion Criteria: - Diagnoses of schizophrenia, schizo-affective, bipolar, or other psychotic disorder - Serious suicidal risk (Patient responds positively to PHQ-9 question #9) See B.3.4.1. - Severe PTSD (Score greater than 51 on PTSD Checklist for DSM-5) - Severe substance or alcohol dependence (meets DSM-5 criteria of severe) |
Country | Name | City | State |
---|---|---|---|
United States | Rehabilitation R&D Service, Baltimore, MD | Baltimore | Maryland |
United States | Jesse Brown VA Medical Center, Chicago, IL | Chicago | Illinois |
United States | Coatesville VA Medical Center, Coatesville, PA | Coatesville | Pennsylvania |
United States | VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | Dallas | Texas |
United States | Clement J. Zablocki VA Medical Center, Milwaukee, WI | Milwaukee | Wisconsin |
United States | Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota |
United States | Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania |
United States | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Pittsburgh | Pennsylvania |
United States | Washington DC VA Medical Center, Washington, DC | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development | Corporal Michael J. Crescenz VA Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Skills of Cognitive Therapy (Patient Version) Change | 8-item self-report (patient version) and therapist-rated instrument of a 5-point Likert-type scale ranging from (never) to 5 (always or when needed) assesses patients understanding and use of basic CBT skills. | baseline, week 12, and month 9 | |
Secondary | Patient Health Questionnaire (PHQ-9) Change | 9-item questionnaire scoring the DSM-IV criteria for depression as not at all (0) to nearly every day (3); scores of 1 to 4 indicate minimal symptoms while 20 indicates severe depression | baseline and weekly up to 12 weeks |
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