Efficacy and Neural Mediators of Response to Trauma Management Therapy for PTSD

PTSD Clinical Trial

Official title:

Efficacy and Neural Mediators of Response to Trauma Management Therapy for PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03449576
• Other study ID #: D2354-R
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

PTSD is associated with significant interpersonal difficulties that interfere with functioning. As such, this work is intended to evaluate the empirical support for a novel treatment that fills a significant gap in the treatment options available to Veterans with PTSD who suffer with interpersonal difficulties. In this study the investigators will (i) evaluate the efficacy of Trauma Management Therapy (TMT) for treating PTSD-related interpersonal dysfunction, as well as PTSD-related fear and anxiety, and (ii) evaluate neural mediators of clinical improvements associated with TMT.

This work will provide insights into the mechanisms by which treatments may lead to improvements in social functioning, informing both the biological basis of psychotherapy and the development and refinement of alternative therapeutic interventions targeting social impairments.

Treatment seeking Veterans with PTSD will be randomized to one of two treatments: (i) Trauma Management Therapy, consisting of 12 sessions of individualized exposure therapy followed by 24 sessions of group-based social and emotional rehabilitation, or (ii) Exposure + Comparison Treatment Group consisting of 12 sessions of individualized exposure therapy followed by 24 sessions of group-based psychotherapy. Veterans enrolled in both the TMT and EXP+GRP arms will undergo functional neuroimaging as they engage in an emotional image viewing task, as well as two social interaction tasks. Neurobehavioral assessments will be made prior to and following completion of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic

Intervention

Other:
• Trauma Management Therapy
Trauma Management Therapy (TMT) consists of a combination of 12 sessions of individualized exposure therapy and 24 sessions of group-based social and emotion rehabilitation.
• Exposure Therapy with Psychotherapy group
Exposure Therapy with Psychoeducation (EXP+EDU) consists of a combination of 12 sessions of individualized exposure therapy and 24 session of group-based psychoeducation.

Locations

Country	Name	City	State
United States	Salem VA Medical Center, Salem, VA	Salem	Virginia

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	Change in Clinician-Administered PTSD Scale for DSM-5	The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al. 2013; 2017) is a 30 item semi-structured instrument for the diagnosis and assessment of severity of posttraumatic stress disorder (PTSD). Each DSM-5 item is rated on a 0 (absent) to 4 (extreme/incapacitating) scale, and total score is calculated by summing severity scores across items. Total CAPS-5 severity can range from 0 to 80.	CAPS-5 will be assessed at two time-points per participant: pre-treatment (week 0) and at completion of treatment (week 8).
Primary	Change in Social Adjustment Scale - Self-Report	The Social Adjustment Scale (SAS; Weissman & Bothwell, 1976) is a 54 item self-report measure that assesses social adjustment in six social areas of functioning including work, social and leisure activities, extended family, marital, parental, and family. Each item is rated on a five point scale, and within each of domain items are averaged. Thus, scores in each domain can range between 1 (high social adjustment) and 5 (low social adjustment).	SAS will be assessed at two time-points: pre-treatment to treatment (week 0) and at completion of treatment (week 8).
Secondary	Change in PTSD Checklist for DSM-5	The PTSD Checklist for DSM-5 (PCL-5; Weathers et al., 2013; Bovin et al., 2016) is a 20 item self-report measure assessing DSM-5 PTSD symptom severity. Each DSM-5 item is rated on a 0 (absent) to 4 (extreme/incapacitating) scale, and total score is calculated by summing severity scores across items. Total CAPS-5 severity can range from 0 to 80.	The PCL-5 will be assessed at two time-points: pre-treatment to treatment (week 0) and at completion of treatment (week 8).
Secondary	Change in Aggression Questionnaire	Change in Aggression Questionnaire (AQ; Buss & Warren, 2000) is a 34 item self-report measure that assesses severity of self-perceived aggression and anger. Each item is rated on a 1 (Not at all like me) to 5 (Completely like me) scale, and total scores can range from 34 to 170.	AQ will be assessed at two time-points: pre-treatment to treatment (week 0) and at completion of treatment (week 8).
Secondary	Change in Interpersonal Trust Scale	Change in Interpersonal Trust Scale (ITS; Rotter, 1967) is a 25 item self-report measure that assesses trust within relationships. Each item is rated on a 1 (low trust) to 5 (high trust) scale, and total scores can range from 25 to 125.	ITS will be assessed at two time-points: pre-treatment to treatment (week 0) and at completion of treatment (week 8).