Comparing Group Therapies for Veterans With Depression and PTSD

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03979040
• Other study ID #: D2910-R
• Status: Completed
• Phase: N/A
• Start date: February 3, 2021
• Est. completion date: March 30, 2024

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Objective To examine efficacy of G-TBT on improving quality of life, psychological well-being, and social reintegration of Veterans with PTSD, MDD, and related conditions compared to G-DSTs using a non-inferiority design. Patient satisfaction, access, and predictors of feasibility (attendance and discontinuation) also will be assessed.

Recruitment Strategy Veterans will be recruited through the Primary Care - Mental Health Integration, General Outpatient Mental Health, and CBT Clinic programs at the Charleston VAMC. Within these programs, all Veterans reporting symptoms of depression and anxiety meet with a mental health staff member to complete a clinical interview and self-report measures. If Veterans endorse symptoms consistent with a depressive/anxiety disorder, interest in participating in research will be assessed and, if agreeable, the Veteran will be referred to project staff. A study-specific intake appointment will be completed with the project staff to assess inclusion/exclusion criteria (with a targeted sample of 326 VAMC patients), including a semi-structured clinical interview and self-report questionnaires focused on quality of life, social integration, and psychiatric symptoms (described later). Participants who meet inclusion/exclusion criteria will be randomized into a study condition, and will be assigned to a project therapist. Because most VAMC patients who meet study criteria likely will present with multiple depressive/anxiety disorders, principal diagnosis, or the most impairing of the diagnosable disorders, will be used to select patients for participation and inform randomization. Principal diagnosis will be determined via diagnostic severity scores in the Anxiety Disorders Interview Schedule-5 (ADIS-5). To balance diagnoses across the two conditions, a stratified random assignment based on principal diagnosis will be used (MDD and PTSD).

Procedures Eligible VAMC patients will be randomized into one of two treatment conditions:

G-TBT or G-DSTs. Both treatment conditions will include 12 weekly 90-minute group sessions. The general format of sessions will involve: 1) brief check-in; 2) review of materials from previous sessions; 3) review of homework assignments; 4) overview of new materials and in-session exercises; and 5) assignment of homework for next session. Attendance and homework completion will be recorded.

Treatment groups (G-TBT, Group CBT-Depression, Group Cognitive Processing Therapy for PTSD) will require at least 6 participants and maximum of 12 participants to begin. Upon randomization, participants will be notified of the group assignment and expected wait period for the group to begin. Wait periods (in days) will be recorded as an indicator of access to treatment across groups.

Randomization Procedures Participants will be randomly assigned (1:1) to one of the two study arms (n = 104 per arm) using a permuted block randomization procedure. Randomization will be stratified by principal diagnostic group (or most impairing disorder between MDD and PTSD if both disorders are present, based upon ADIS disorder-specific interference and distress severity scores) and block size will be varied to minimize the likelihood of unmasking. If both disorders evidence identical severity scores (highly unlikely), participants will be asked which of the two disorders is more impairing/significant for randomization purposes. After determining eligibility and completing consent and baseline assessment materials, enrolled participants will be assigned to treatment conditions by the Research Coordinator/Therapist using a computer-generated randomization scheme. Once a participant is randomized, they will be included in the intent-to-treat analysis. Randomization will occur at the participant level.

Group Transdiagnostic Behavior Therapy TBT was developed as a streamlined protocol 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.

G-DSTs Control Condition Matching and Assignment 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. Participants randomized to a G-DST group will be matched to the G-DST based on the principal diagnosis determined via the ADIS-5.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: March 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

• participant must be a Veteran enrolled at Veterans Affairs Medical center within the Charleston VAMC catchment area

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Ralph H. Johnson VA Medical Center, Charleston, SC	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. 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 week 6 to week 12 to 6-month followup
Primary	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, 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 week 6 to week 12 to 6-month followup
Primary	PTSD Checklist for DSM-5 (PCL-5)	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.	change from baseline to week 6 to week 12 to 6-month followup