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NCT Number: NCT06296589

Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure

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?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Little Rock Veterans Health Care System (LRVHCS), Little Rock, Arkansas, United States

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About this study

Trauma-related guilt is common and impairing among trauma survivors. Guilt is positively associated with severity of PTSD and depression symptoms, poorer psychosocial functioning and suicide risk. Although existing evidence-based trauma-focused PTSD treatments such as Prolonged Exposure (PE) are effective in treating PTSD and trauma-related guilt, many still experience symptoms or maintain their diagnosis after treatment. Preliminary research shows that a brief treatment targeting trauma-related and moral injury-related guilt and shame, Trauma Informed Guilt Reduction Therapy (TrIGR), can reduce guilt, PTSD, depression, and distress among Veterans and help them reengage with meaningful activities. Whether TrIGR is comparably effective to longer, more resource heavy evidence-based PTSD treatments disseminated across DoD and VA, like PE, is a critical question.

The proposed randomized clinical trial aims to determine if TrIGR is non-inferior to a first tier PTSD treatment, PE. Hypotheses are that 6 sessions of TrIGR will be non-inferior to 12 sessions of PE in reducing PTSD symptom severity among Veterans with PTSD who endorse trauma-related guilt. Secondary aims are to evaluate the hypotheses that TrIGR will be non-inferiority relative to PE in improving psychosocial functioning and depression symptoms and superior in reducing trauma-related guilt and shame. The study will also explore treatment differences in change in suicidal ideation and dropout.

Participants will be recruited from mental health clinics across three VAs. 158 Veterans who served since 9/11 and with PTSD and guilt from any type of trauma will be included. TrIGR will be administered over 6 weekly sessions (60-minutes each) and PE will be administered over 12 weekly sessions (90 minutes each). Blind assessors will evaluate participants at baseline and 8-, 16-, and 28 weeks after the first therapy session. Inclusion and exclusion criteria are minimized so that generalizability will be high.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • U.S. Veterans age 18 or older who served in the military since the start of Operation Enduring Freedom/Operation Iraqi Freedom; OEF/OIF)
  • meets diagnostic criteria for PTSD;
  • a score of 2 or higher ("true" to "extremely true") on feeling trauma-related guilt much or all of the time or scoring 3 or higher ("very true" or "extremely true") on at least one guilt cognition factor (hindsight bias/responsibility, wrongdoing, or lack of justification) on the Trauma Related Guilt Inventory
  • not currently receiving trauma-focused treatment such as PE or CPT
  • willingness to attend psychotherapy and assessment sessions

Exclusion criteria

  • current risk of suicidal/homicidal behavior that requires immediate intervention
  • current severe substance use disorder (in the past two months) based on DSM-5 criteria
  • current unmanaged psychosis or mania
  • life threatening or unstable medical illness
  • inability to read

Treatment and study plan

Trauma Informed Guilt Reduction Therapy

Behavioral

Behavioral therapy for trauma related guilt and shame

Prolonged Exposure Therapy

Behavioral

Behavioral exposure therapy for PTSD

Primary outcomes

  1. Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

    Time frame: baseline and 8-, 16-, and 28 weeks after the first therapy session

    Measures PTSD symptom severity, score range 0-80, higher scores mean greater symptom severity

Secondary outcomes

  1. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: baseline and 8-, 16-, and 28 weeks after the first therapy session

    Depression symptom severity, range = 0-27, higher scores mean greater depression symptom severity

  2. Brief Psychosocial Functioning Inventory (B-IPF)

    Time frame: baseline and 8-, 16-, and 28 weeks after the first therapy session

    Measures severity of impairment in psychosocial functioning, scores = 0-100, higher scores indicate greater impairment

  3. Trauma Related Guilt Inventory Cognitions Scale (TRGI)

    Time frame: baseline and 8-, 16-, and 28 weeks after the first therapy session

    Measures severity of trauma related guilt cognitions, scores = 0-4, higher scores indicate greater guilt

  4. Trauma Related Shame Inventory (TRSI)

    Time frame: baseline and 8-, 16-, and 28 weeks after the first therapy session

    Measures severity of trauma related shame, scores = 0-96, higher scores indicate greater shame

Study contacts

Contact information is provided by the study sponsor or research team.

Kaitlyn Panza, PhD

CONTACT

[email protected]

858-552-8585

Sonya Norman, PhD

CONTACT

[email protected]

858-518-8266

Sponsors and collaborators

Lead sponsor

Veterans Medical Research Foundation

Other

Collaborators

  • Center for Veterans Research and Education
  • University of Minnesota

Registry information

Official study title

Clinical Effectiveness and Implementation of Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure (TrIGR)

Acronym: PORT

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 6, 2024
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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