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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
TrIGR/CPT Trial 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.Check my eligibility
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.See study design
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.
TrIGR/CPT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 28 weeks later
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 28 weeks later
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
change in Clinician Administered PTSD Scale - 5 (CAPS-5)
Secondary outcome measures
Trauma Related Guilt Inventory (TRGI)
Trauma Related Shame Inventory (TRSI)
change in Patient Health Questionnaire - 9 (PHQ-9)
TrIGR/CPT 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
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,126 Total Patients Enrolled
Sonya B. Norman, PhDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA
3 Previous Clinical Trials
456 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with PTSD or have symptoms close to PTSD.I am a U.S. Veteran aged 18 or older.I am willing to go to therapy and assessment sessions.I do not have any severe or unstable illnesses.I am not currently undergoing any trauma-focused treatments like CPT or PE.
Research Study Groups:
This trial has the following groups:- Group 1: Trauma Informed Guilt Reduction Therapy (TrIGR)
- Group 2: Cognitive Processing Therapy (CPT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities to participate in this scientific trial?
"Clinicaltrials.gov demonstrates that this medical investigation is not searching for new participants, as the trial was uploaded on June 1st 2023 and amended March 15th 2023. However, there are 397 other trials actively recruiting patients at present."
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