Guilt Reduction vs Cognitive Processing Therapy for PTSD

(TrIGR/CPT Trial)

Recruiting at1 trial location

Overseen by Sonya B. Norman, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Severe substance use, Psychosis, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Trauma-related guilt is common and impairing among trauma survivors, particularly among Veterans with posttraumatic stress disorder (PTSD). The investigators' work shows that a brief treatment targeting trauma-related guilt, Trauma Informed Guilt Reduction Therapy (TrIGR), can reduce guilt and PTSD and depression symptoms. Whether TrIGR is no less effective than longer, more resource heavy PTSD treatments disseminated by by VA, like cognitive processing therapy (CPT), is the next critical question that this study will seek to answer. 158 Veterans across two VA sites will be randomized to TrIGR or CPT to evaluate changes in PTSD, depression, guilt and shame symptoms across the two treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you should not be receiving trauma-focused treatments like cognitive processing therapy or prolonged exposure therapy.

What data supports the effectiveness of the treatment Trauma-Informed Guilt Reduction Therapy (TrIGR) for PTSD?

Research suggests that Trauma-Informed Guilt Reduction Therapy (TrIGR) can help reduce trauma-related guilt and distress, which is linked to improvements in PTSD and depression symptoms. Studies with veterans have shown that TrIGR may effectively decrease guilt severity and improve mental health outcomes. ^{1 2 3 4 5}

Is Trauma-Informed Guilt Reduction Therapy (TrIGR) safe for humans?

Research on Trauma-Informed Guilt Reduction Therapy (TrIGR) and Cognitive Processing Therapy (CPT) suggests they are generally safe for humans, as they are forms of talk therapy used to address trauma-related guilt and PTSD. No specific safety concerns have been reported in the studies reviewed. ^{1 2 3 4 5}

How does Trauma Informed Guilt Reduction Therapy (TrIGR) differ from other PTSD treatments?

TrIGR is unique because it specifically targets trauma-related guilt, helping patients understand their role in the trauma and find positive ways to express their values, which can reduce feelings of guilt and shame. This focus on guilt is different from other PTSD treatments that may not address guilt as directly. ^{1 2 3 4 5}

Research Team

Sonya B. Norman, PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with PTSD or have symptoms close to PTSD.

I am a U.S. Veteran aged 18 or older.

A score of 2 or higher on feeling trauma-related guilt much or all of the time or scoring 3 or higher on at least one guilt cognition factor on the Trauma Related Guilt Inventor

Exclusion Criteria

Current severe substance use disorder (in the past two months) based on DSM-5 criteria

Impaired mental status as measured by the Montreal Cognitive Assessment (MoCA) (score < 21) and confirmed by a neuropsychologist

Veterans with significant current risk of suicidal/homicidal behavior

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Trauma Informed Guilt Reduction Therapy (TrIGR) or Cognitive Processing Therapy (CPT) to evaluate changes in PTSD, depression, guilt, and shame symptoms

12 weeks

Follow-up

Participants are monitored for changes in PTSD, depression, guilt, and shame symptoms

28 weeks

Treatment Details

Interventions

• Cognitive Processing Therapy (Behavioral Intervention)
• Trauma Informed Guilt Reduction Therapy (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: Trauma Informed Guilt Reduction Therapy (TrIGR) Experimental Treatment 1 Intervention

behavioral intervention aimed to reduce trauma-related guilt and shame

Group II: Cognitive Processing Therapy (CPT) Active Control 1 Intervention

behavioral intervention aimed at reducing PTSD symptoms

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Findings from Research

Cognitive therapy targeting guilt can enhance the treatment of PTSD, as demonstrated in a preliminary observation of 8 patients who underwent this therapy followed by standard prolonged exposure therapy.

Addressing guilt in PTSD treatment may improve outcomes, especially for patients with predominant feelings of anger or guilt, suggesting that this approach could also benefit those with similar issues in other disorders like depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive therapy of trauma related guilt in patients with PTSD]. Popiel, A.[2018]

Trauma-Informed Guilt Reduction (TrIGR) therapy was found to be more effective than Supportive Care Therapy (SCT) in reducing trauma-related guilt among veterans, with a significant decrease in guilt levels and a higher likelihood of PTSD treatment response (67% vs. 40%).

TrIGR also led to greater improvements in PTSD diagnosis loss (50% vs. 14%) and meaningful changes in depression symptoms (54% vs. 27%) compared to SCT, indicating its efficacy in addressing both guilt and associated mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical trial comparing trauma-informed guilt reduction therapy (TrIGR), a brief intervention for trauma-related guilt, to supportive care therapy. Norman, SB., Capone, C., Panza, KE., et al.[2022]

Trauma Informed Guilt Reduction (TrIGR) therapy, a cognitive-behavioral approach, shows promise in reducing guilt related to combat trauma among veterans, as indicated by a pilot study involving 10 recently deployed combat veterans.

The study found that reductions in trauma-related guilt were closely linked to decreases in PTSD and depression symptoms, suggesting that addressing guilt may be an important factor in improving overall mental health outcomes for veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma Informed Guilt Reduction Therapy With Combat Veterans. Norman, SB., Wilkins, KC., Myers, US., et al.[2022]

In a study of 360 veterans undergoing a 3-week intensive Cognitive Processing Therapy (CPT) program, trauma-related guilt cognitions significantly decreased, indicating that CPT effectively addresses guilt associated with PTSD.

Changes in specific guilt cognitions, particularly hindsight bias and responsibility, were strong predictors of reductions in PTSD and depression symptoms, suggesting that targeting these cognitions may enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in guilt cognitions in intensive PTSD treatment among veterans who experienced military sexual trauma or combat trauma. Meade, EA., Smith, DL., Montes, M., et al.[2022]

Trauma-Informed Guilt Reduction Therapy (TrIGR) is effective in reducing trauma-related guilt, PTSD, and depression symptoms in post-9/11 veterans, as shown in a randomized controlled trial with 144 participants.

Participants in the TrIGR therapy had a higher likelihood of losing their PTSD diagnosis and showed significant clinical improvements, attending an average of 5.3 out of 6 sessions, indicating strong engagement with the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-Informed Guilt Reduction Therapy: Overview of the Treatment and Research. Norman, S.[2022]

References

1. Poland pubmed.ncbi.nlm.nih.gov

[Cognitive therapy of trauma related guilt in patients with PTSD]. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

A clinical trial comparing trauma-informed guilt reduction therapy (TrIGR), a brief intervention for trauma-related guilt, to supportive care therapy. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Trauma Informed Guilt Reduction Therapy With Combat Veterans. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Changes in guilt cognitions in intensive PTSD treatment among veterans who experienced military sexual trauma or combat trauma. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Trauma-Informed Guilt Reduction Therapy: Overview of the Treatment and Research. [2022]