Trauma Informed Guilt Reduction Therapy

NCT ID: NCT02512445

Last Updated: 2025-05-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2023-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Guilt Shame Post-traumatic Stress Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

188 enrollment goal for primary study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Trauma Informed Guilt Reduction Therapy

6-session psychotherapy intervention

Group Type EXPERIMENTAL

Trauma Informed Guilt Reduction Therapy

Intervention Type BEHAVIORAL

Trauma focused therapy

Supportive Care Therapy

6-session psychotherapy intervention

Group Type ACTIVE_COMPARATOR

Supportive Care Therapy

Intervention Type BEHAVIORAL

Supportive therapy

Interventions

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Trauma Informed Guilt Reduction Therapy

Trauma focused therapy

Intervention Type BEHAVIORAL

Supportive Care Therapy

Supportive therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role collaborator

Seattle Institute for Biomedical and Clinical Research

OTHER

Sponsor Role collaborator

White River Junction Veterans Affairs Medical Center

FED

Sponsor Role collaborator

San Diego Veterans Healthcare System

FED

Sponsor Role collaborator

Providence VA Medical Center

FED

Sponsor Role collaborator

National Center for PTSD

FED

Sponsor Role collaborator

Veterans Medical Research Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sonya B. Norman, PhD

Role: PRINCIPAL_INVESTIGATOR

Veterans Medical Research Foundation

Christy Capone, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

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VA San Diego Healthcare System

San Diego, California, United States

Site Status

National Center for PTSD

Boston, Massachusetts, United States

Site Status

VA Providence Medical Center

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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McCue ML, Capone CC, Wachen JS, Harle KM, Davis BC, Panza KE, Lyons M, Luciano MT, Shea MT, Haller M, Galovski TE, Schnurr PP, Norman SB. Addressing pandemic-related guilt and shame in U.S. military veterans: A pilot randomized controlled trial of trauma-informed guilt reduction and supportive care therapy. Psychol Trauma. 2025 Oct 23. doi: 10.1037/tra0002036. Online ahead of print.

Reference Type DERIVED
PMID: 41129362 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33326878 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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09054

Identifier Type: -

Identifier Source: org_study_id

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