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

February 22, 2024 updated by: VA Office of Research and Development

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

268

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20422-0001
        • Recruiting
        • Washington DC VA Medical Center, Washington, DC
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Not yet recruiting
        • Jesse Brown VA Medical Center, Chicago, IL
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Recruiting
        • Rehabilitation R&D Service, Baltimore, MD
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417-2309
        • Recruiting
        • Minneapolis VA Health Care System, Minneapolis, MN
        • Contact:
    • Pennsylvania
      • Coatesville, Pennsylvania, United States, 19320-2040
        • Recruiting
        • Coatesville VA Medical Center, Coatesville, PA
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19104-4551
        • Recruiting
        • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
        • Contact:
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15240
        • Recruiting
        • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
        • Contact:
        • Principal Investigator:
          • Judith Ann Callan, PhD RN
    • Texas
      • Dallas, Texas, United States, 75216-7167
        • Recruiting
        • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53295-0001
        • Recruiting
        • Clement J. Zablocki VA Medical Center, Milwaukee, WI
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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) Change
Time Frame: 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.
baseline, week 12, and month 9

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire (PHQ-9) Change
Time Frame: 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
baseline and weekly up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 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 (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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