N/A N=15 Randomized Treatment

Does Adding a Tailored Cognitive Behavioral Therapy (CBT) Mobile Skills App Mediate Rates of Depression

Depression

Bottom Line

View on ClinicalTrials.gov: NCT04002063 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2025

Primary outcome: Primary: Skills of Cognitive Therapy (Patient Version) — 24.231; 24.231 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CBT MobileWork-V plus CBT (Behavioral); CBT alone (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Mar 2024

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	—

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.

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)

View full record on ClinicalTrials.gov →

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.