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

Primary Purpose

PTSD

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trauma Management Therapy
Exposure Therapy with Psychotherapy group
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PTSD focused on measuring PTSD, neuroimaging, fMRI, veterans, exposure therapy, treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Salem VA Medical Center, Salem, VA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Trauma Management Therapy

Exposure Therapy with Psychoeducation

Arm Description

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 Psychoeducation (EXP+EDU) consists of a combination of 12 sessions of individualized exposure therapy and 24 session of group-based psychoeducation.

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
February 15, 2018
Last Updated
July 5, 2022
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03449576
Brief Title
Efficacy and Neural Mediators of Response to Trauma Management Therapy for PTSD
Official Title
Efficacy and Neural Mediators of Response to Trauma Management Therapy for PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
PTSD, neuroimaging, fMRI, veterans, exposure therapy, treatment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trauma Management Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Exposure Therapy with Psychoeducation
Arm Type
Active Comparator
Arm Description
Exposure Therapy with Psychoeducation (EXP+EDU) consists of a combination of 12 sessions of individualized exposure therapy and 24 session of group-based psychoeducation.
Intervention Type
Other
Intervention Name(s)
Trauma Management Therapy
Other Intervention Name(s)
TMT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exposure Therapy with Psychotherapy group
Other Intervention Name(s)
EXP+GRP
Intervention Description
Exposure Therapy with Psychoeducation (EXP+EDU) consists of a combination of 12 sessions of individualized exposure therapy and 24 session of group-based psychoeducation.
Primary Outcome Measure Information:
Title
Change in Clinician-Administered PTSD Scale for DSM-5
Description
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.
Time Frame
CAPS-5 will be assessed at two time-points per participant: pre-treatment (week 0) and at completion of treatment (week 8).
Title
Change in Social Adjustment Scale - Self-Report
Description
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).
Time Frame
SAS will be assessed at two time-points: pre-treatment to treatment (week 0) and at completion of treatment (week 8).
Secondary Outcome Measure Information:
Title
Change in PTSD Checklist for DSM-5
Description
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.
Time Frame
The PCL-5 will be assessed at two time-points: pre-treatment to treatment (week 0) and at completion of treatment (week 8).
Title
Change in Aggression Questionnaire
Description
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.
Time Frame
AQ will be assessed at two time-points: pre-treatment to treatment (week 0) and at completion of treatment (week 8).
Title
Change in Interpersonal Trust Scale
Description
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.
Time Frame
ITS will be assessed at two time-points: pre-treatment to treatment (week 0) and at completion of treatment (week 8).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brooks King-Casas, PhD
Organizational Affiliation
Salem VA Medical Center, Salem, VA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salem VA Medical Center, Salem, VA
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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