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
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Ralph H. Johnson VA Medical Center, Charleston, SC | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
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 |
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