Clinical trial NCT02512445: Trauma Informed Guilt Reduction Therapy
Official title: Trauma Informed Guilt Reduction Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Guilt
Shame
Post-traumatic Stress Disorders
Lead sponsor: Veterans Medical Research Foundation
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Brown University
name: Seattle Institute for Biomedical and Clinical Research
name: White River Junction Veterans Affairs Medical Center
name: San Diego Veterans Healthcare System
name: Providence VA Medical Center
name: National Center for PTSD
First posted: 2015-07-30
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 188 enrollment goal for primary study
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Trauma Related Guilt Inventory - Guilt Severity
timeFrame: baseline to 8 months
Secondary outcomes:
measure: Change in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale - 5 (CAPS-5)
timeFrame: baseline to 8 months
measure: Change in Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: baseline to 8 months
measure: Change in Internalized Shame Scale
timeFrame: baseline to 8-month follow-up
measure: Change in World Health Organization Quality of Life - Brief
timeFrame: baseline to 8 months
measure: Change in Brief Symptom Inventory-18
timeFrame: baseline to 8 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
city: Boston
country: United States
facility: National Center for PTSD
state: Massachusetts
city: Providence
country: United States
facility: VA Providence Medical Center
state: Rhode Island
Study officials:
affiliation: Veterans Medical Research Foundation
name: Sonya B. Norman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Christy Capone, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.