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Behavioral Intervention

Guilt Reduction vs Cognitive Processing Therapy for PTSD (TrIGR/CPT Trial)

N/A
Recruiting
Led By Sonya B. Norman, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 28 weeks later
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare a brief trauma-related guilt therapy to a longer PTSD therapy to see which is more effective in reducing guilt and symptoms of PTSD and depression in veterans.

Who is the study for?
This trial is for U.S. Veterans aged 18 or older who have PTSD or subthreshold PTSD, feel trauma-related guilt often, and are not currently in any trauma-focused treatment like CPT or PE. They must be willing to attend therapy sessions and score above certain thresholds on the Trauma Related Guilt Inventory.
What is being tested?
The study compares TrIGR (Trauma Informed Guilt Reduction Therapy), a brief treatment aimed at reducing trauma-related guilt, with CPT (Cognitive Processing Therapy), a longer-established method. The goal is to see if TrIGR is just as effective as CPT in treating symptoms of PTSD, depression, guilt, and shame among Veterans.
What are the potential side effects?
While specific side effects are not listed for psychotherapies like TrIGR and CPT, participants may experience emotional discomfort when discussing traumatic events which can include increased anxiety, sadness or reliving past traumas.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 28 weeks later
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 28 weeks later for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
change in Clinician Administered PTSD Scale - 5 (CAPS-5)
Secondary study objectives
Trauma Related Guilt Inventory (TRGI)
Trauma Related Shame Inventory (TRSI)
change in Patient Health Questionnaire - 9 (PHQ-9)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Trauma Informed Guilt Reduction Therapy (TrIGR)Experimental Treatment1 Intervention
behavioral intervention aimed to reduce trauma-related guilt and shame
Group II: Cognitive Processing Therapy (CPT)Active Control1 Intervention
behavioral intervention aimed at reducing PTSD symptoms

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,439 Total Patients Enrolled
Sonya B. Norman, PhDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA
3 Previous Clinical Trials
456 Total Patients Enrolled

Media Library

Cognitive Processing Therapy (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05789329 — N/A
Post-Traumatic Stress Disorder Research Study Groups: Trauma Informed Guilt Reduction Therapy (TrIGR), Cognitive Processing Therapy (CPT)
Post-Traumatic Stress Disorder Clinical Trial 2023: Cognitive Processing Therapy Highlights & Side Effects. Trial Name: NCT05789329 — N/A
Cognitive Processing Therapy (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05789329 — N/A
~98 spots leftby Mar 2027
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