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Comparing Group Therapies for Veterans With Depression and PTSD

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ClinicalTrials.gov Identifier: NCT03979040
Recruitment Status : Not yet recruiting
First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Cognitive behavioral therapy (CBT) is a brief, efficient, and effective psychotherapy for individuals with depressive and PTSD. However, CBT is largely underutilized within Veteran Affairs Medical Centers (VAMCs) due to the cost and burden of trainings necessary to deliver the large number of CBT protocols. Transdiagnostic Behavior Therapy (TBT), in contrast, is specifically designed to address numerous distinct disorders within a single protocol. The transdiagnostic approach of TBT has the potential to dramatically improve the accessibility of CBT within VAMCs and therefore improve clinical outcomes of Veterans. The proposed research seeks to evaluate the efficacy of a group version of TBT (G-TBT) by assessing clinical outcomes and quality of life in VAMC patients with major depressive disorder and PTSD throughout the course of treatment and in comparison to two existing group disorder-specific therapies (G-DST), CBT for Depression and Cognitive Processing Therapy for PTSD.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Posttraumatic Stress Disorder Behavioral: Group Transdiagnostic Behavior Therapy Behavioral: Group Disorder-Specific Therapy (G-DSTs) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Group Transdiagnostic Behavior Therapy (G-TBT) to Disorder-Specific Group Psychotherapies in the Recovery of Veterans With PTSD, Major Depression and Related Conditions
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group Transdiagnostic Behavior Therapy
TBT was developed to address transdiagnostic avoidance via the use of four different types of exposure techniques (situational/in-vivo, physical/interoceptive, thought/imaginal, and [positive] emotional/behavioral activation). From the transdiagnostic avoidance perspective, the four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders. Per protocol, the first six sessions of TBT are designed to educate on, prepare for, and practice the four different types of exposure techniques. The next five sessions are focused on practicing and refining exposure practices as participants work through their lists of avoided situations/sensation/thoughts. The final session reviews treatment progress and relapse prevention strategies.
Behavioral: Group Transdiagnostic Behavior Therapy
TBT was developed to address transdiagnostic avoidance via the use of four different types of exposure techniques (situational/in-vivo, physical/interoceptive, thought/imaginal, and [positive] emotional/behavioral activation). From the transdiagnostic avoidance perspective, the four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders. Per protocol, the first six sessions of TBT are designed to educate on, prepare for, and practice the four different types of exposure techniques. The next five sessions are focused on practicing and refining exposure practices as participants work through their lists of avoided situations/sensation/thoughts. The final session reviews treatment progress and relapse prevention strategies.

Active Comparator: Group Disorder-Specific Therapy (G-DSTs)
To provide an evidence-based comparison for the G-TBT condition, G-DSTs will be used that are matched to the participant?s principal diagnosis. G-DSTs will include groups for the most common principal diagnoses that have VA-approved protocols and training programs, including PTSD (Cognitive Processing Therapy for PTSD) and MDD (CBT-Depression). Each of these G-DSTs have published manuals for administration and have received extensive support in the literature.
Behavioral: Group Disorder-Specific Therapy (G-DSTs)
To provide an evidence-based comparison for the G-TBT condition, G-DSTs will be used that are matched to the participant's principal diagnosis. G-DSTs will include groups for the most common principal diagnoses that have VA-approved protocols and training programs, including PTSD (Cognitive Processing Therapy for PTSD) and MDD (CBT-Depression). Each of these G-DSTs have published manuals for administration and have received extensive support in the literature.




Primary Outcome Measures :
  1. Depression Anxiety Stress Scale (DASS-Depression) [ Time Frame: change from baseline to week 6 to week 12 to 6-month followup ]
    The DASS-Depression is a 7-item measure designed to assess dysphoric mood. Items are rated on a 4-point Likert scale, ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), and summed to compute the total scale. Higher scores are indicative of greater symptom severity. The factor structure, reliability, and validity of the subscales have been supported in the literature.

  2. Illness Intrusiveness Ratings Scale (IIRS) [ Time Frame: change from baseline to week 6 to week 12 to 6-month followup ]
    The IIRS is a 13-item questionnaire that assesses the extent to which a disease interferes with important domains of life, including health, diet, work, and several others. Each item is rated on a 7-point Likert scale, ranging from 1 (not very much) to 7 (very much). Items are summed to create the total score, with higher scores indicative of greater impairment. The IIRS has been shown to have high internal consistency in the previous literature.

  3. PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: change from baseline to week 6 to week 12 to 6-month followup ]
    The PCL-5 is a 20-item self-report measure that assesses DSM-5 criteria PTSD symptoms. Previous versions of the PCL have been shown to have excellent internal consistency and excellent test-retest reliability in veterans. In addition, the PCL-5 has been incorporated into standard assessment for PTSD at the VA.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • participants must be clearly competent to provide informed consent for research participation;
  • participants must meet DSM-5 diagnostic criteria for a principal diagnosis of a major depressive disorder or posttraumatic stress disorder

Exclusion Criteria:

  • recent history (< 2 months) of psychiatric hospitalization or a suicide attempt as documented in their medical record or reported during clinical interview
  • current diagnosis of substance use disorder as documented in their medical record or reported during clinical interview
  • acute, severe illness or medical condition that likely will require hospitalization and/or otherwise interfere with study procedures as documented in their medical record (e.g., active chemotherapy/radiation treatment for cancer, kidney dialysis, oxygen therapy for chronic obstructive pulmonary disease),
  • recent start of new psychiatric medication (< 4 weeks)
  • diagnosis of traumatic brain injury (TBI) in their medical record and/or endorsement of screener questionnaire regarding the symptoms of TBI modified from the Post-Deployment Health Assessment employed by the Department of Defense
  • diagnosis of schizophrenia, psychotic symptoms, personality disorder, and/or bipolar disorder as documented in their medical record or reported during clinical interview
  • VAMC patients excluded due to these factors will be reconsidered for participation once the condition related to their exclusion is resolved or stabilized
  • Ineligible VAMC patients will be referred for non-study-related treatments within mental health at the Ralph H. Johnson VA Medical Center

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): NCT03979040


Contacts
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Contact: Sarah Szafranski (832) 577-5011 ext 5316 Sarah.Szafranski@va.gov
Contact: Daniel F Gros, PhD MA BS (843) 789-6225 ext 6225 daniel.gros@va.gov

Locations
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United States, South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC Not yet recruiting
Charleston, South Carolina, United States, 29401-5799
Contact: Sarah Szafranski    832-577-5011 ext 5316    Sarah.Szafranski@va.gov   
Contact: Daniel F Gros, PhD MA BS    (843) 789-6225 ext 6225    daniel.gros@va.gov   
Principal Investigator: Daniel F Gros, PhD MA BS         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Daniel F Gros, PhD MA BS Ralph H. Johnson VA Medical Center, Charleston, SC

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03979040     History of Changes
Other Study ID Numbers: D2910-R
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon consultation with the local VA R&D and MUSC IRB committees after publication of primary research questions, the de-identified database will be made available to the public via the publishing journal's website (where applicable) as well as on (yet to be determined/selected) research community websites designed for the sharing of scientific findings and data.
Supporting Materials: Study Protocol
Time Frame: starting 6 months after publication of the primary outcome papers

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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

Additional relevant MeSH terms:
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Disease
Depression
Depressive Disorder
Depressive Disorder, Major
Stress Disorders, Post-Traumatic
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders