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

Does Adding a Tailored Cognitive Behavioral Therapy (CBT) Mobile Skills App Mediate Higher Rates of Depression Recovery, Adjustment, and Quality of Life in OEF/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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: CBT MobileWork-V plus CBT; Behavioral: CBT alone

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20422-0001
      • Washington DC VA Medical Center, Washington, DC
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Jesse Brown VA Medical Center, Chicago, IL
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Rehabilitation R&D Service, Baltimore, MD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417-2309
      • Minneapolis VA Health Care System, Minneapolis, MN
  • Pennsylvania
    • Coatesville, Pennsylvania, United States, 19320-2040
      • Coatesville VA Medical Center, Coatesville, PA
    • Philadelphia, Pennsylvania, United States, 19104-4551
      • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
    • Pittsburgh, Pennsylvania, United States, 15240
      • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
  • Texas
    • Dallas, Texas, United States, 75216-7167
      • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53295-0001
      • Clement J. Zablocki VA Medical Center, Milwaukee, WI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT-D augmented with CBT MobileWork-V; 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; a smartphone app to assist with CBT homework skills practice plus CBT
Active Comparator: CBT-D; Patients randomized to CBT-D will receive CBT-D as usual only.	Behavioral: CBT MobileWork-V plus CBT; a smartphone app to assist with CBT homework skills practice plus CBT; Behavioral: CBT alone; CBT therapy individual; Other Names: CBT-D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire (PHQ-9)	The Patient Health Questionnaire-9 (PHQ-9) is a screening tool for assessing depression. It is a self-reported questionnaire that helps gauge the severity of depressive symptoms. Components of PHQ-9. Each question asks the patient to rate how often they have been bothered by specific problems over the past two weeks. The total score on the PHQ-9 ranges from 0 to 27. Interpreting PHQ-9 Scores: 0-4: Minimal or no depression 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression 20-27: Severe depression	week 12

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Corporal Michael J. Crescenz VA Medical Center
• Investigators: Principal Investigator: Judith Ann Callan, PhD RN, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: June 20, 2019
• First Submitted That Met QC Criteria: June 27, 2019
• First Posted (Actual): June 28, 2019

Study Record Updates

• Last Update Posted (Estimated): October 27, 2025
• Last Update Submitted That Met QC Criteria: October 10, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Cognitive Behavioral Therapy; OEF/OIF; Mobile Apps
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression
• Other Study ID Numbers: D2908-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No