Neuroimaging the Impact of Treatment on Neural Substrates of Trust in Post-Traumatic Stress Disorder (PTSD)

NCT01244477 | Completed Results

• 1 other identifier: B7760-P
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Traumatic experiences can have a profound negative effect on the lives and well-being of both the people who experience them and their loved ones. For those who experience post-traumatic stress disorder (PTSD), their interpersonal difficulties and social support further impact the success of treatment such that interpersonal difficulties are associated with mistrust and predict poor treatment outcome. In this proposal, the investigators use functional neuroimaging to understand the neurobiology of trust and mistrust in people with PTSD and to learn more about how successful treatment can improve trust and social functioning.

Conditions

Stress Disorders, Post Traumatic; Trust

Keywords

Stress Disorders, Post Traumatic; Trust; functional Magnetic Resonance Imaging (fMRI)

Outcome Measures

Primary Outcomes (2)

• Continuous Whole Brain Imaging With Standard Imaging Parameters for Each Functional Magnetic Resonance Imaging (fMRI) Scan

  Pre & post a 12 week treatment group

• The Clinician Administered PTSD Scale (CAPS)

  The CAPS is considered the gold standard measure of PTSD symptoms. CAPS scores are the sum of 17 questions. Each is question is scored from 0 (best possible outcome) to 8 (worst possible outcome). The lowest possible CAPS score is a 0, indicating no PTSD symptoms reported. The highest possible CAPS score is a 136, indicating the most PTSD symptoms reported.

  Pre & post a 12 week treatment group

Secondary Outcomes (2)

• Behavioral Expression of Trust on the Trust Game

  Pre & post a 12 week treatment group

• PTSD Checklist (PCL)

  Administered each week at weekly group sessions or pre-post treatment as usual

Study Arms (2)

CPT-C

EXPERIMENTAL

Participants in group CPT-C

Behavioral: Group CPT-C

Treatment-as-Usual

NO INTERVENTION

Participants randomly assigned to the Waitlist Control Group (who will participate in CPT-C after 12 weeks).

Interventions

Group CPT-C BEHAVIORAL

Participants will be randomly assigned to participate in CPT-C or a 12 week waitlist control group. Waitlist control subjects will participate in CPT-C after the 12 weeks.

CPT-C

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Meet criteria for PTSD on the Clinician Administered PTSD Scale (CAPS)
• Priority will be given to Veterans aged 18-50 who have had an onset of symptoms in the past 10 years and are Veterans of Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF)
• Have been referred for placement in CPT treatment by a clinician in the Trauma Recovery Program at the Michael E DeBakey VA Medical Center (MEDVAMC) or an eligible Veteran who contacts study staff.
• Are able to see the computer display clearly with or without magnetic Resonance imaging (MRI)-compatible corrective lenses
• Are free from current non-psychiatric medical problems impacting cognitive functioning.
• Are cleared to participate by a treating MEDVAMC clinician
• Are able to participate in functional MRI (fMRI)

You may not qualify if:

• Meet Diagnostic and Statistical Manual-IV (DSM-IV)criteria for drug or alcohol abuse in the past 30 days
• History of moderate to severe traumatic brain injury based on any of the following:
• (i) Glasgow Coma Score \< 13
• (ii)alteration of consciousness \> 24 hours; loss of consciousness,30 minutes
• Presence of contraindications to MRI, including but not limited to:
• claustrophobia
• pacemaker
• metal in eyes
• other implants
• Current neurological or general medical conditions known to impact cognitive and/or emotional functioning, including but limited to:
• epilepsy
• Parkinson's disease
• Huntington's disease
• Alzheimer's disease
• stroke

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Combat Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Limitations and Caveats

This is a pilot study based on a small sample of Veterans with PTSD.

Results Point of Contact

• Title: Wright Williams, PhD, ABPP
• Organization: Michael E DeBakey VAMC

wright.williams@va.gov

713-794-7629

Study Officials

• Wright Williams, PhD

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 19, 2010
• Study Start: May 16, 2011
• Primary Completion: May 31, 2013
• Study Completion: June 30, 2018
• Last Updated: June 27, 2019
• Results First Posted: December 2, 2014

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)