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

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ClinicalTrials.gov Identifier: NCT04002063
Recruitment Status : Not yet recruiting
First Posted : June 28, 2019
Last Update Posted : June 28, 2019
Sponsor:
Collaborator:
Corporal Michael J. Crescenz VA Medical Center
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: CBT MobileWork-V plus CBT Behavioral: CBT alone Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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?
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


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 Name: CBT-D




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002063


Contacts
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Contact: Janelle Altman (412) 360-3550 Janelle.Altman@va.gov
Contact: Elizabeth B Toth, BA (412) 954-5382 elizabeth.toth2@va.gov

Locations
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United States, Pennsylvania
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kyong-Mi Chang, MD    215-823-5800 ext 5893    Kyong-Mi.Chang@va.gov   
Contact: Lisa Dorman    2158235800 ext 6024    lisa.dorman@va.gov   
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Steven H Graham, MD PhD    (412) 360-2914    steven.graham@va.gov   
Contact: Janelle Altman    (412) 360-3550    Janelle.Altman@va.gov   
Principal Investigator: Judith Ann Callan, PhD RN         
Sponsors and Collaborators
VA Office of Research and Development
Corporal Michael J. Crescenz VA Medical Center
Investigators
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Principal Investigator: Judith Ann Callan, PhD RN VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04002063     History of Changes
Other Study ID Numbers: D2908-R
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
Depression
OEF/OIF
Mobile Apps
Cognitive Behavioral Therapy
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders