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Trauma Informed Guilt Reduction Therapy (TrIGR)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2015 by Veterans Medical Research Foundation
Sponsor:
Collaborators:
Brown University
Seattle Institute for Biomedical and Clinical Research
White River Junction VAMC
San Diego Veterans Healthcare System
Providence VA Medical Center
Information provided by (Responsible Party):
Veterans Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT02512445
First received: July 27, 2015
Last updated: July 29, 2015
Last verified: July 2015
  Purpose

The goal of this project is to determine if a 6-session psychotherapy intervention will help Veterans feel less deployment-related guilt and less distress related to their guilt. Half of the participants will receive the guilt focused intervention and half will receive a supportive intervention.


Condition Intervention Phase
Guilt
Shame
Post-traumatic Stress Disorders
Behavioral: Trauma Informed Guilt Reduction Therapy
Behavioral: Supportive Care Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trauma Informed Guilt Reduction Therapy

Resource links provided by NLM:


Further study details as provided by Veterans Medical Research Foundation:

Primary Outcome Measures:
  • Change in Trauma Related Guilt Inventory - Guilt Severity [ Time Frame: baseline to 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Brief Symptom Inventory-18 [ Time Frame: baseline to 8 months ] [ Designated as safety issue: No ]
  • Internalized Shame Scale [ Time Frame: up to 6-months post-treatmetn follow-up ] [ Designated as safety issue: No ]
  • Change in World Health Organization Quality of Life - Brief [ Time Frame: baseline to 8 months ] [ Designated as safety issue: No ]
  • Change in Clinician Administered post traumatic stress disorder (PTSD) Scale [ Time Frame: baseline to 8 months ] [ Designated as safety issue: No ]
  • Change in Patient Health Questionnaire - 9 [ Time Frame: baseline to 8 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 188
Study Start Date: October 2015
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trauma Informed Guilt Reduction Therapy
6-session psychotherapy intervention
Behavioral: Trauma Informed Guilt Reduction Therapy
Trauma focused therapy
Active Comparator: Supportive Care Therapy
6-session psychotherapy intervention
Behavioral: Supportive Care Therapy
Supportive therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant Served in OEF/OIF/OND, has post-traumatic guilt related to deployment event

Exclusion Criteria:

  • Moderate or severe cognitive impairment, acute suicidality, current severe substance use disorder, unmanaged psychosis or mania
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02512445

Contacts
Contact: Erika Blanes, MPH 858-552-8585 erika.blanes@va.gov

Locations
United States, California
VA San Diego Healthcare System Not yet recruiting
San Diego, California, United States, 92161
Contact: Sonya Norman, PhD         
United States, Rhode Island
VA Providence Medical Center Not yet recruiting
Providence, Rhode Island, United States, 02908
Contact: Christy Capone, PhD         
Sponsors and Collaborators
Veterans Medical Research Foundation
Brown University
Seattle Institute for Biomedical and Clinical Research
White River Junction VAMC
San Diego Veterans Healthcare System
Providence VA Medical Center
Investigators
Principal Investigator: Sonya B. Norman, PhD Veterans Medical Research Foundation
Principal Investigator: Christy Capone, PhD Brown University
  More Information

No publications provided

Responsible Party: Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT02512445     History of Changes
Other Study ID Numbers: 09054
Study First Received: July 27, 2015
Last Updated: July 29, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2015