Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Veterans Medical Research Foundation
Study ID
NCT06296589
Status
Recruiting

Conditions

  • Stress Disorders, Post-Traumatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trauma Informed Guilt Reduction Therapy — BEHAVIORAL
    Behavioral therapy for trauma related guilt and shame
  • Prolonged Exposure Therapy — BEHAVIORAL
    Behavioral exposure therapy for PTSD

Study Details

The goal of this clinical trial is to learn if receiving Trauma-Informed Guilt Reduction (TrIGR) Therapy is as effective as receiving Prolonged Exposure Therapy among veterans with PTSD and trauma related guilt. The main questions it aims to answer are: Will TrIGR be comparable to PE in terms of PTSD symptom reduction? Will it TrIGR be comparable to PE in improving functioning and reducing depression symptoms? Will it be superior in improving trauma-related guilt and shame?

Key Dates

Start date
Dec 1, 2024
Status verified
Apr 2025
Primary completion
Jul 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
158 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: trauma Informed Guilt Reduction Therapy
    6 session behavioral intervention focused on trauma-related guilt, shame, and moral injury
  • Active Comparator: Prolonged Exposure Therapy
    12 session behavioral intervention focused on PTSD symptoms

Primary Outcome Measure

Clinician Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: baseline and 8-, 16-, and 28 weeks after the first therapy session ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Little Rock Veterans Health Care System (LRVHCS)Little RockArkansas72205
Brandon Griffin
501-257-1000
Southeast Louisiana Veterans Health Care System (SLVHCS)New OrleansLouisiana70119
Laurel Franklin, PhD
800-935-8387
William S. Middleton Memorial HospitalMadisonWisconsin53705
Michael Messina, PhD
608-284-6302

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