Does Adding a Tailored Cognitive Behavioral Therapy (CBT) Mobile Skills App Mediate Rates of Depression
- Conditions
- Depression
- Interventions
- Behavioral: CBT MobileWork-V plus CBTBehavioral: CBT alone
- Registration Number
- NCT04002063
- Lead Sponsor
- VA Office of Research and Development
- Brief Summary
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.
- Detailed Description
Cognitive Behavioral Therapy (CBT) is the leading evidence-based psychotherapy for depression, which affects 18.5% of Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans (hereafter referred to as OEF/OIF). Yet, OEF/OIF Veterans had only a 30% average reduction in mean depression scores from the initial to later phase of treatment. This was true despite the rigorous training and certification procedures for VA CBT-D. Improving the rate of depression recovery and remission is vital to enhance OEF/OIF Veteran's ability to improve work and home adjustment and overall quality of life.
Broad access to all key ingredients of CBT, including skills practice (homework), is associated with improved and faster recovery from depression. OEF/OIF Veterans and patients with depression have reported many barriers (i.e., time, chaotic lifestyles, and low energy) to following through with their skills practice assignments. In the absence of targeted strategies/interventions to address the barriers that prevent CBT skills practice, OEF/OIF Veterans will remain unable to reap the full benefits/effects of CBT. With specific tailored interventions to address this gap in treatment, OEF/OIF Veterans will improve rates of recovery from depression, diminished home and work adjustment, and poor quality of life.
Leveraging the technological savvy of this generation of Veterans to improve access to CBT skills practice is a logical tactic to address this gap in treatment. Smartphone apps have been identified as a useful widely-used tool to improve the effectiveness of psychological treatments. There is, however, a paucity of empirical studies on the use of mobile apps in the treatment of depressed OEF/OIF Veterans and in psychological treatment overall. The promising pilot results of a comprehensive tailored smartphone app for CBT skills practice for OEF/OIF Veterans ("CBT MobileWork-V"), provides initial evidence for a larger-scale randomized clinical trial (RCT) to measure the efficacy of CBT enhanced with CBTMobileWork-V (the experimental arm) for improving CBT understanding and skill acquisition and depressive symptoms, in OEF/OIF Veterans with depression compared to standard CBT-D. Specifically, over a 27-month period the study will randomize 268 eligible OEF/OIF Veterans with depressive symptoms, to either CBT augmented with the comprehensive CBT skill training smartphone app CBT MobileWork-V or standard CBT-D with traditional skills practice methods (i.e., paper and pencil). The Specific Aims of this study are:
Primary Aim 1) To assess whether CBT-D augmented with CBT MobileWork-V (hereafter referred to as CBT-D+) promotes greater CBT understanding and skill acquisition compared to traditional CBT-D.
Primary Aim 2a) To examine the short-term effect in depressive symptoms after 12 weeks of CBT-D+ versus standard CBT-D.
Primary Aim 2b) To examine the long-term effect in depressive symptoms at 6 months post treatment of the CBT-D+ intervention versus traditional CBT-D.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CBT-D CBT MobileWork-V plus CBT Patients randomized to CBT-D will receive CBT-D as usual only. CBT-D CBT alone Patients randomized to CBT-D will receive CBT-D as usual only. CBT-D augmented with CBT MobileWork-V CBT MobileWork-V plus CBT 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.
- Primary Outcome Measures
Name Time Method Skills of Cognitive Therapy (Patient Version) Change baseline, week 12, and month 9 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.
- Secondary Outcome Measures
Name Time Method Patient Health Questionnaire (PHQ-9) Change baseline and weekly up to 12 weeks 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
Trial Locations
- Locations (9)
Rehabilitation R&D Service, Baltimore, MD
🇺🇸Baltimore, Maryland, United States
Jesse Brown VA Medical Center, Chicago, IL
🇺🇸Chicago, Illinois, United States
Washington DC VA Medical Center, Washington, DC
🇺🇸Washington, District of Columbia, United States
Minneapolis VA Health Care System, Minneapolis, MN
🇺🇸Minneapolis, Minnesota, United States
Coatesville VA Medical Center, Coatesville, PA
🇺🇸Coatesville, Pennsylvania, 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
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