N/A
N=69
Efficacy and Neural Mediators of Response to Trauma Management Therapy for PTSD
PTSD
Bottom Line
View on ClinicalTrials.gov: NCT03449576 ↗Enrolled (actual)
69
Serious AEs
2.9%
Results posted
Jul 2024
Primary outcome: Primary: Change in Clinician-Administered PTSD Scale for DSM-5 — 38.39; 35.67; 27.15; 29.31 score on a scale — p=0.4154
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Trauma Management Therapy (Other); Exposure Therapy with Psychotherapy group (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Clinician-Administered PTSD Scale for DSM-5 |
38.39; 35.67; 27.15; 29.31 | 0.4154 |
| PRIMARY Change in Social Adjustment Scale - Self-Report |
2.855; 3.168; 2.953; 3.289 | 0.4636 |
| PRIMARY Change in PTSD Checklist for DSM-5 |
53.66; 56.92; 40.04; 46.53 | 0.735129 |
| SECONDARY Change in Aggression Questionnaire |
59; 64.62; 58.92; 62.18 | 0.580 |
| SECONDARY Change in Interpersonal Trust Scale |
60.21; 57.54; 63.33; 60.41 | 0.808 |
Summary
Social difficulties are serious and frequent complicating factors in the treatment of post-traumatic stress disorder (PTSD). To better understand how treatment of post-traumatic stress disorder impacts neural mechanisms of social cognition, the investigators are examining behavior and brain processes associated with response to Trauma Management Therapy. Understanding the behavioral and neural impact of psychotherapy may contribute to development of more effective treatments for PTSD.
Eligibility Criteria
Inclusion Criteria
- Male and female veterans of all ethnicities
- Meet diagnostic criteria for post-traumatic stress disorder (assessed by study staff)
- Fluent in English
- Able to see computer display clearly
- Able to provide informed consent
- Able to follow written or verbal instructions
Exclusion Criteria
- history of seizures
- history of stroke
- Cushing's syndrome
- history of moderate to severe traumatic brain injury
- electroconvulsive therapy within 5 years
- history of chemotherapy for cancer
- contraindications to fMRI
- pregnancy
- diagnosis of schizophrenia, schizoaffective disorder, delusional disorder and/or organic psychosis
Data sourced from ClinicalTrials.gov (NCT03449576). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.