Comparing Individual Therapies for Veterans With Depression, PTSD, and Panic Disorder

Major Depressive Disorder Clinical Trial

Official title:

A Comparison of the Efficacy of Transdiagnostic Behavior Therapy and Disorder-specific Therapy in Veterans With PTSD, Anxiety, and Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04293341
• Other study ID #: MHBB-005-19S
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: March 31, 2025

Study information

• Verified date: February 2024
• Source: VA Office of Research and Development
• Contact: Daniel F Gros, PhD MA BS
• Phone: (843) 789-6225
• Email: daniel.gros[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cognitive behavioral therapy (CBT) is a brief, efficient, and effective treatment for individuals with depressive/anxiety disorders. However, CBT is largely underutilized within the Department of Veterans Affairs due to the cost and burden of trainings necessary to deliver all of the related disorder-specific treatments (DSTs). Transdiagnostic Behavior Therapy (TBT), in contrast, is specifically designed to address numerous distinct disorders within a single protocol in Veterans with depressive/anxiety disorders, including posttraumatic stress disorder. The proposed research seeks to evaluate the efficacy of TBT by assessing psychiatric symptomatology and related impairment outcomes in Veterans with depressive/anxiety disorders via a randomized controlled trial of TBT and existing DSTs in Veterans with major depressive disorder, posttraumatic stress disorder, and panic disorder. Assessments will be completed at pre-, mid-, and post-treatment, and at 6-month follow-up. Process variables also will be investigated.

Description:

Objective To examine efficacy of Transdiagnostic Behavior Therapy (TBT) on improving psychiatric symptomatology and related impairments in Veterans with major depressive disorder (MDD), posttraumatic stress disorder (PTSD), and panic disorder and agoraphobia (PD/AG) compared to disorder-specific treatments (DSTs) via a non-inferiority design. Patient satisfaction and predictors of feasibility (attendance and discontinuation) also will be assessed.

Recruitment Strategy and Feasibility of Recruitment Veterans will be recruited through the Primary Care Mental Health Integration, General Outpatient Mental Health, and CBT Clinic programs at the Ralph H. Johnson VAMC and all affiliated VA community-based outpatient clinics. IRB-approved study flyers will be distributed through each clinic/setting. 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 research assessment will be completed with the project staff to first complete consent documentation and then assess inclusion/exclusion criteria (with a targeted sample of 306 VAMC patients), including a semi-structured clinical interview and self-report questionnaires focused on psychiatric symptomatology and related impairments (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 VA Medical Center (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 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, PTSD, and PD/AG).

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

TBT or DSTs. Both treatment conditions will include 12 weekly 45- to 60-minute treatment 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.

Randomization Procedures Participants will be randomly assigned (1:1) to one of the two study arms (n = 108 per arm) using a permuted block randomization procedure. Randomization will be stratified by diagnostic group (PTSD, PD/AG, MDD) and block size will be varied to minimize the likelihood of unmasking. After determining eligibility and completing consent and baseline assessment materials, enrolled participants will be assigned to their treatment condition by the Research Project Therapist/Coordinator using a computer-generated randomization scheme.

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). 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.

DSTs Control Condition Matching and Assignment To provide an evidence-based comparison for the TBT condition, DSTs will be used that are matched to the participant's most severe diagnosis, based upon the average of the ADIS interference and distress scores. If the scores are equivalent for two or more diagnoses, participants will be asked to list which diagnosis/symptoms that they find most impairing. DSTs will be included for each of the three targeted diagnoses, including PTSD (Cognitive Processing Therapy for PTSD), PD/AG (Cognitive Behavioral Therapy for PD/AG), and MDD (Cognitive Behavioral Therapy for MDD). Each of these DSTs have published manuals for administration and have received extensive support in the literature (Barlow, 2014). All three DSTs have been shown to improve comorbid symptomatology and therefore may be a more accurate comparison to TBT as compared to other available DSTs that may have less effect on comorbidity (e.g., applied relaxation for PD/AG).

Assessment of Psychiatric Symptomatology, and Treatment Satisfaction The battery of self-report questionnaires and a diagnostic interview will be completed pre-, mid-, and post-treatment and at the 6-month follow-up to track participants' progression through treatment and maintenance. To reduce the likelihood of missing data, all assessments will be scheduled separately from normal treatment sessions. Assessments of disorder-specific symptomatology, as well general symptoms of the depressive/anxiety disorders and related impairments, were chosen due to the transdiagnostic focus of the proposed study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: March 31, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Participants must be Veterans

• Participants must be clearly competent to provide informed consent for research participation

• Participants must meet DSM-5 criteria for panic disorder, major depressive disorder, or posttraumatic stress disorder

• Participants must be 18-80 years old

Exclusion Criteria:

• recent history (< 2 months) of psychiatric hospitalization or a suicide attempt 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),

• recent start of new psychiatric medication (< 4 weeks)

• diagnosis of moderate-to-severe traumatic brain injury in their medical record and/or endorsement of screener questionnaire

• additional comorbid psychiatric diagnoses that were not listed as exclusion criteria are permitted as long as they are considered secondary to the principal diagnosis of MDD, PTSD, or PD/AG as determined by the diagnostic interview

• ineligible Veterans will be referred for non-study-related treatments within mental health at the RHJ VAMC

Related Conditions & MeSH terms

• Agoraphobia
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Panic Disorder
• Panic Disorder and Agoraphobia
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• 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.
• Cognitive Processing Therapy for PTSD
CPT is a well established evidence-based psychotherapy for PTSD. CPT focuses on teaching patients to evaluate and change the upsetting thoughts that they have had since their trauma.
• Cognitive Behavioral Therapy for MDD
CBT for MDD is a well established evidence-based psychotherapy for depression. CBT for MDD focuses teaching patients how to change their behaviors and challenge their negative thoughts to improve their mood.
• Cognitive Behavioral Therapy for Panic Disorder
CBT for Panic Disorder is a well established evidence-based psychotherapy. CBT for Panic Disorder focuses teaching patients how to change their behaviors through exposure practices and challenge their anxious thoughts to reduce their experience of panic attacks and avoidance.

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	PTSD Checklist for DSM-5 (PCL-5)	The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses DSM-5 criteria PTSD symptoms. Items are scored on a 5-point scale, range from 0 (not at all) to 4 (extremely). The total scale score ranges from 0 to 80 with higher scores associated with more severe symptomatology. 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. The PCL5 will be used to assess symptoms of PTSD.	change from baseline to week 6 to week 12 to 6-month followup
Primary	Patient Health Questionnaire - 9 (PHQ-9)	The Patient Health Questionnaire - 9 (PHQ-9) is a 9-item depression scale derived from the Patient Health Questionnaire to assess the symptoms and diagnosis of depression. Items are scored on a 4-point scale, range from 0 (not at all) to 3 (nearly every day). The total scale score ranges from 0 to 27 with higher scores associated with more severe symptomatology. The PHQ-9 has been shown to have good reliability as well as validity in clinical samples. In addition, the PHQ-9 has been incorporated into standard screenings at the VA. The PHQ-9 will be used to assess symptoms of MDD.	change from baseline to week 6 to week 12 to 6-month followup
Primary	Panic Disorder Severity Scale (PDSS)	The Panic Disorder Severity Scale (PDSS) is a 7-item scale for the frequency and distress of panic attacks and related symptoms. Items are scored on a 5-point scale, range from 0 (no symptoms) to 4 (extreme symptoms). The total scale score ranges from 0 to 28 with higher scores associated with more severe symptomatology. The scale has demonstrated good internal consistency, test-retest reliability, and sensitivity to change during the course of treatment . The PDSS will be used to assess symptoms of PD/AG.	change from baseline to week 6 to week 12 to 6-month followup