Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433271
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-22
Brief Title:
Transdiagnostic Behavior Therapy vs TAU for Adjustment Disorder Following Traumatic Event Exposure
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Comparative Effectiveness of Transdiagnostic Behavior Therapy vs TAU for Adjustment Disorder Following Traumatic Event Exposure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
Adjustment Disorder AjD is the most common mental health condition diagnosed in Active Duty personnel and is diagnosed following an extreme stress event such as traumatic loss of a comrade serious accident or injury or other intense stress event Despite its high prevalence no evidence based treatment for AjD has been subjected to randomized controlled trials This study seeks to build on the research teams pilot work across several disorders study to benefit service members and Veterans with AjD a highly prevalent but frequently inadequately treated condition
The investigators will compare the effects of Transdiagnostic Behavior Therapy TBT vs treatment as usual which is Moving Forward Problem Solving Therapy TAU-PST on AjD symptom outcomes The investigators hypothesize that TBT will result in greater overall symptom reduction compared to TAU-PST
The investigators will compare the effects of Transdiagnostic Behavior Therapy TBT vs treatment as usual which is Moving Forward Problem Solving Therapy TAU-PST on AjD symptom outcomes The investigators hypothesize that TBT will result in greater overall symptom reduction compared to TAU-PST
Detailed Description:
Adjustment Disorder AjD is the most common mental health condition diagnosed in Active Duty personnel and is diagnosed following an extreme stress event such as traumatic loss of a comrade serious accident or injury or other intense stress event Despite its high prevalence no evidence based treatment for AjD has been subjected to randomized controlled trials
Currently the VA suggests a problem solving cognitive behavioral therapy but this recommendation is not based on replicated randomized controlled trials Transdiagnostic Behavior Therapy TBT is based on key active components of existing evidence based treatments such as Prolonged Exposure and Behavioral Activation has been designed by this research team to be easily trained and inexpensively disseminated and has been evaluated in a series of pilots with anxiety and depression disorders that importantly represent the key symptom classes of adjustment disorder
Thus the rationale for the proposed trial is that the research team has done preliminary efficacy testing of an easily exportable intervention that has impact on the key symptoms of adjustment disorder and the standard of evidence demands replicated randomized controlled trials to determine if initial signals of positive effect are sustained
The study will use a 2 group repeated measures randomized controlled design to evaluate effectiveness of TBT for AjD compared to treatment as usual TAU-PST Participants will be randomly assigned in equal numbers n 75 N 150 to one of two treatment arms 1 TBT or 2 TAU-PST Participants assigned to TBT will receive 6 30-45-minute manualized individual therapy sessions Participants assigned to TAU-PST will receive 6 30-45-minute sessions of Problem-Solving Therapy Dependent measures will include Department of Defense DoD specified common data elements and specific measures of AjD PTSD anxiety depression and functioning collected by blinded assessors at baseline post-treatment 3-month and 6-month follow-up
Currently the VA suggests a problem solving cognitive behavioral therapy but this recommendation is not based on replicated randomized controlled trials Transdiagnostic Behavior Therapy TBT is based on key active components of existing evidence based treatments such as Prolonged Exposure and Behavioral Activation has been designed by this research team to be easily trained and inexpensively disseminated and has been evaluated in a series of pilots with anxiety and depression disorders that importantly represent the key symptom classes of adjustment disorder
Thus the rationale for the proposed trial is that the research team has done preliminary efficacy testing of an easily exportable intervention that has impact on the key symptoms of adjustment disorder and the standard of evidence demands replicated randomized controlled trials to determine if initial signals of positive effect are sustained
The study will use a 2 group repeated measures randomized controlled design to evaluate effectiveness of TBT for AjD compared to treatment as usual TAU-PST Participants will be randomly assigned in equal numbers n 75 N 150 to one of two treatment arms 1 TBT or 2 TAU-PST Participants assigned to TBT will receive 6 30-45-minute manualized individual therapy sessions Participants assigned to TAU-PST will receive 6 30-45-minute sessions of Problem-Solving Therapy Dependent measures will include Department of Defense DoD specified common data elements and specific measures of AjD PTSD anxiety depression and functioning collected by blinded assessors at baseline post-treatment 3-month and 6-month follow-up
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PR230007 | OTHER_GRANT | United States Army Medical Research and Development Command | None |