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

NCT04002063 | Completed Results DMC

• 1 other identifier: D2908-R
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 9

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.

Conditions

Depression

Keywords

Depression; OEF/OIF; Mobile Apps; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

• Skills of Cognitive Therapy (Patient Version)

  The Skills of Cognitive Therapy Scale (SoCT) is 8-item self-report (patient version) of a 5-point Likert-type scale ranging from 1 (never) to 5 (always or when needed) assesses patients understanding and use of basic CBT skills in depressed adults. The eight-item SoCT assesses patients' understanding and use of basic cognitive therapy (CT) skills rated from the perspectives of patients (SoCT-P). Ratings of patients' skill usage are made on 5-point Likert-type scales ranging from 1 ("never") to 5 ("always or when needed"). Total scores range 8 - 40. Higher scores reflect greater patient skill in applying cognitive therapy principles and coping strategies.

  week 12

Secondary Outcomes (1)

• Patient Health Questionnaire (PHQ-9)

  week 12

Study Arms (2)

CBT-D augmented with CBT MobileWork-V

EXPERIMENTAL

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.

Behavioral: CBT MobileWork-V plus CBT

CBT-D

ACTIVE COMPARATOR

Patients randomized to CBT-D will receive CBT-D as usual only.

Behavioral: CBT MobileWork-V plus CBT; Behavioral: CBT alone

Interventions

CBT MobileWork-V plus CBT BEHAVIORAL

a smartphone app to assist with CBT homework skills practice plus CBT

CBT-D; CBT-D augmented with CBT MobileWork-V

CBT alone BEHAVIORAL

CBT therapy individual

Also known as: CBT-D

CBT-D

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Corporal Michael J. Crescenz VA Medical Center: collaborator

Study Sites (9)

Washington DC VA Medical Center, Washington, DC

Washington D.C., District of Columbia, 20422-0001, United States

Location

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

Location

Rehabilitation R&D Service, Baltimore, MD

Baltimore, Maryland, 21202, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

Location

Coatesville VA Medical Center, Coatesville, PA

Coatesville, Pennsylvania, 19320-2040, United States

Location

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104-4551, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, 75216-7167, United States

Location

Clement J. Zablocki VA Medical Center, Milwaukee, WI

Milwaukee, Wisconsin, 53295-0001, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Limitations and Caveats

* COVID 19 pandemic \& Contracts for s/w programmers delayed, Programming \& bug fixes from prototype, enhanced features, \& Veteran specific materials * Contract for data server \& website at the U Pittsburgh delayed, VA cyber security approval (2.5 years), Admin delays, especially during COVID)- CIRB, staff onboarding, site onboarding, local sites IRB, Therapist onboarding delays: VAMC clinician shortages, Trends in CBT treatment (less visits, group therapy, etc.) changed since study inception

Results Point of Contact

• Title: Judith A. Callan PhD, RN
• Organization: VHAPTH

judith.callan@va.gov

412-628-1534

Study Officials

• Judith Ann Callan, PhD RN

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 28, 2019
• Study Start: October 10, 2022
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: October 27, 2025
• Results First Posted: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)