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Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure

ConditionStress Disorders, Post-Traumatic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVeterans Medical Research Foundation

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Trauma Informed Guilt Reduction Therapy

    Behavioral

    Behavioral therapy for trauma related guilt and shame

  • Prolonged Exposure Therapy

    Behavioral

    Behavioral exposure therapy for PTSD

Treatment groups

158 Participants
are divided into 2 treatment groups
Group A: trauma Informed Guilt Reduction TherapyExperimental treatment 1 intervention
Group B: Prolonged Exposure TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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

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

Secondary outcomes

1

Patient Health Questionnaire-9 (PHQ-9)

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

Time frame
baseline and 8-, 16-, and 28 weeks after the first therapy session
2

Brief Psychosocial Functioning Inventory (B-IPF)

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

Time frame
baseline and 8-, 16-, and 28 weeks after the first therapy session
3

Trauma Related Guilt Inventory Cognitions Scale (TRGI)

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

Time frame
baseline and 8-, 16-, and 28 weeks after the first therapy session
4

Trauma Related Shame Inventory (TRSI)

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Veterans Medical Research Foundation

Lead sponsor

University of Minnesota

Collaborator

Center for Veterans Research and Education

Collaborator

Source ClinicalTrials.gov
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