Comparing Group Therapies for Veterans With Depression and PTSD

NCT03979040 | Completed Results DMC

• 1 other identifier: D2910-R
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (3)

• Depression Anxiety Stress Scale (DASS-Depression)

  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 that ranges from 0 to 21. Higher scores are indicative of greater symptom severity. The factor structure, reliability, and validity of the subscales have been supported in the literature.

  change from baseline to 6-month follow-up

• Illness Intrusiveness Ratings Scale (IIRS)

  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 (ranging from 1 to 91), with higher scores indicative of greater impairment. The IIRS has been shown to have high internal consistency in the previous literature.

  change from baseline to 6-month follow-up

• PTSD Checklist for DSM-5 (PCL-5)

  The PCL-5 is a 20-item self-report measure that assesses DSM-5 criteria PTSD symptoms. Items are rated on a 5-point Likert scale, ranging from 0 (not at all) to 4 (extremely), and summed to compute the total scale that ranges from 0 to 80. Higher scores are indicative of greater symptom severity. 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.

  change from baseline to 6-month follow-up

Study Arms (2)

Group Transdiagnostic Behavior Therapy

EXPERIMENTAL

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

Group Disorder-Specific Therapy (G-DSTs)

ACTIVE COMPARATOR

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 Major Depressive Disorder (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)

Interventions

Group Transdiagnostic Behavior Therapy BEHAVIORAL

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.

Group Transdiagnostic Behavior Therapy

Group Disorder-Specific Therapy (G-DSTs) BEHAVIORAL

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 Depression (CBT-Depression). Each of these G-DSTs have published manuals for administration and have received extensive support in the literature.

Group Disorder-Specific Therapy (G-DSTs)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• participants must be clearly competent to provide informed consent for research participation;
• participants must meet Diagnostic and Statistical Manual-5 diagnostic criteria for a principal diagnosis of a major depressive disorder or posttraumatic stress disorder
• participant must be a Veteran enrolled at Veterans Affairs Medical center within the Charleston VAMC catchment area

You may not qualify if:

• 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 in their medical record and/or endorsement of screener questionnaire regarding the symptoms of traumatic brain injury 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
• Ineligible VAMC patients will be referred for non-study-related treatments within mental health at the Ralph H. Johnson VA Medical Center

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Limitations and Caveats

Recruitment was set to begin in Spring 2020. The COVID pandemic resulted in significant delays, as well as in changes in the methods of the study (e.g., shifted to telehealth). These two changes likely contributed in the higher-than-expected treatment discontinuation (group psychotherapy via telehealth) and missing data (traditional mail delivery-return of questionnaires). The target sample was increased to adjust for the missing data based on updated power analyses.

Results Point of Contact

• Title: Dr. Nik Allan - Study Statistician
• Organization: VA Finger Lakes Health Care System

Nicholas.Allan@osumc.edu

(850) 274-0567

Study Officials

• Daniel F Gros, PhD MA BS

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 7, 2019
• Study Start: February 3, 2021
• Primary Completion: June 30, 2023
• Study Completion: March 30, 2024
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: starting 6 months after publication of the primary outcome papers

Locations

US (1)