Ignite Creation Date:
2024-05-06 @ 1:14 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03979040
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2019-06-05
Brief Title:
Comparing Group Therapies for Veterans With Depression and PTSD
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Objective To examine efficacy of G-TBT on improving quality of life psychological well-being and social reintegration of Veterans with PTSD Major Depressive Disorder 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 depressiveanxiety 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 inclusionexclusion 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 inclusionexclusion 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 depressiveanxiety 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 To balance diagnoses across the two conditions a stratified random assignment based on principal diagnosis will be used Major Depressive Disorder 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 11 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 Major Depressive Disorder and PTSD if both disorders are present based upon 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 impairingsignificant for randomization purposes After determining eligibility and completing consent and baseline assessment materials enrolled participants will be assigned to treatment conditions by the Research CoordinatorTherapist 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 situationalin-vivo physicalinteroceptive thoughtimaginal and positive emotionalbehavioral activation From the transdiagnostic avoidance perspective the four exposure practices are matched to the types of avoidance experienced by patients based upon their cluster of symptomsdisorders 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 situationssensationthoughts 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 participants 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 Participants randomized to a G-DST group will be matched to the G-DST based on the principal diagnosis determined via the diagnostic interview
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 depressiveanxiety 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 inclusionexclusion 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 inclusionexclusion 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 depressiveanxiety 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 To balance diagnoses across the two conditions a stratified random assignment based on principal diagnosis will be used Major Depressive Disorder 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 11 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 Major Depressive Disorder and PTSD if both disorders are present based upon 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 impairingsignificant for randomization purposes After determining eligibility and completing consent and baseline assessment materials enrolled participants will be assigned to treatment conditions by the Research CoordinatorTherapist 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 situationalin-vivo physicalinteroceptive thoughtimaginal and positive emotionalbehavioral activation From the transdiagnostic avoidance perspective the four exposure practices are matched to the types of avoidance experienced by patients based upon their cluster of symptomsdisorders 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 situationssensationthoughts 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 participants 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 Participants randomized to a G-DST group will be matched to the G-DST based on the principal diagnosis determined via the diagnostic interview
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None