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Trauma Informed Guilt Reduction Therapy (TrIGR)

Primary Purpose

Guilt, Shame, Post-traumatic Stress Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trauma Informed Guilt Reduction Therapy
Supportive Care Therapy
Sponsored by
Veterans Medical Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Guilt

Eligibility Criteria

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

Inclusion Criteria:

  • Participant Served in OEF/OIF/OND, has post-traumatic guilt related to deployment event (for pandemic supplement in 2021, has guilt related to pandemic event)

Exclusion Criteria:

  • Moderate or severe cognitive impairment, acute suicidality, current severe substance use disorder, unmanaged psychosis or mania

Sites / Locations

  • VA San Diego Healthcare SystemRecruiting
  • National Center for PTSDRecruiting
  • VA Providence Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Trauma Informed Guilt Reduction Therapy

Supportive Care Therapy

Arm Description

6-session psychotherapy intervention

6-session psychotherapy intervention

Outcomes

Primary Outcome Measures

Change in Trauma Related Guilt Inventory - Guilt Severity

Secondary Outcome Measures

Change in Clinician Administered post traumatic stress disorder (PTSD) Scale
Change in Patient Health Questionnaire - 9
Internalized Shame Scale
Change in World Health Organization Quality of Life - Brief
Change in Brief Symptom Inventory-18

Full Information

First Posted
July 27, 2015
Last Updated
May 4, 2022
Sponsor
Veterans Medical Research Foundation
Collaborators
United States Department of Defense, Brown University, Seattle Institute for Biomedical and Clinical Research, White River Junction Veterans Affairs Medical Center, San Diego Veterans Healthcare System, Providence VA Medical Center, National Center for PTSD
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1. Study Identification

Unique Protocol Identification Number
NCT02512445
Brief Title
Trauma Informed Guilt Reduction Therapy
Acronym
TrIGR
Official Title
Trauma Informed Guilt Reduction Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 2015 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Veterans Medical Research Foundation
Collaborators
United States Department of Defense, Brown University, Seattle Institute for Biomedical and Clinical Research, White River Junction Veterans Affairs Medical Center, San Diego Veterans Healthcare System, Providence VA Medical Center, National Center for PTSD

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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. A supplemental pilot study added in FY2021 will examine the intervention for pandemic-related guilt events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Guilt, Shame, Post-traumatic Stress Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
188 enrollment goal for primary study, 75 enrollment goal for 2021 pandemic guilt supplement study
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
188 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trauma Informed Guilt Reduction Therapy
Arm Type
Experimental
Arm Description
6-session psychotherapy intervention
Arm Title
Supportive Care Therapy
Arm Type
Active Comparator
Arm Description
6-session psychotherapy intervention
Intervention Type
Behavioral
Intervention Name(s)
Trauma Informed Guilt Reduction Therapy
Intervention Description
Trauma focused therapy
Intervention Type
Behavioral
Intervention Name(s)
Supportive Care Therapy
Intervention Description
Supportive therapy
Primary Outcome Measure Information:
Title
Change in Trauma Related Guilt Inventory - Guilt Severity
Time Frame
baseline to 8 months (for supplemental study of pandemic guilt in 2021, timeframe is baseline to 3 months)
Secondary Outcome Measure Information:
Title
Change in Clinician Administered post traumatic stress disorder (PTSD) Scale
Time Frame
baseline to 8 months
Title
Change in Patient Health Questionnaire - 9
Time Frame
baseline to 8 months
Title
Internalized Shame Scale
Time Frame
up to 6-months post-treatmetn follow-up
Title
Change in World Health Organization Quality of Life - Brief
Time Frame
baseline to 8 months
Title
Change in Brief Symptom Inventory-18
Time Frame
baseline to 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant Served in OEF/OIF/OND, has post-traumatic guilt related to deployment event (for pandemic supplement in 2021, has guilt related to pandemic event) Exclusion Criteria: Moderate or severe cognitive impairment, acute suicidality, current severe substance use disorder, unmanaged psychosis or mania
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sonya Norman, PhD
Phone
858-552-8585
Email
snorman@ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonya B. Norman, PhD
Organizational Affiliation
Veterans Medical Research Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christy Capone, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonya Norman, PhD
Facility Name
National Center for PTSD
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Wachen, PhD
Phone
857-364-5444
Email
Jennifer.wachen@va.gov
First Name & Middle Initial & Last Name & Degree
Jennifer Wachen, PhD
Facility Name
VA Providence Medical Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christy Capone, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33326878
Citation
Capone C, Norman SB, Haller M, Davis B, Shea MT, Browne K, Lang AJ, Schnurr PP, Golshan S, Afari N, Pittman J, Allard CB, Westendorf L. Trauma Informed Guilt Reduction (TrIGR) therapy for guilt, shame, and moral injury resulting from trauma: Rationale, design, and methodology of a two-site randomized controlled trial. Contemp Clin Trials. 2021 Feb;101:106251. doi: 10.1016/j.cct.2020.106251. Epub 2020 Dec 14.
Results Reference
derived

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Trauma Informed Guilt Reduction Therapy

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