N/A
Completed N=15
Does Adding a Tailored Cognitive Behavioral Therapy (CBT) Mobile Skills App Mediate Rates of Depression
Source: ClinicalTrials.gov NCT04002063 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcomePrimary: Skills of Cognitive Therapy (Patient Version) — 24.231; 24.231 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Skills of Cognitive Therapy (Patient Version) |
24.231; 24.231 | — |
| SECONDARY Patient Health Questionnaire (PHQ-9) |
23.798; 18.004 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT04002063). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.