Guilt Reduction vs Cognitive Processing Therapy for PTSD

(TrIGR/CPT Trial)

Recruiting at 1 trial location

Overseen By Kaitlyn Panza, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Severe substance use, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

158 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two therapy approaches for Veterans struggling with PTSD and trauma-related guilt. The study compares Trauma Informed Guilt Reduction Therapy (TrIGR), which targets guilt and shame, with Cognitive Processing Therapy (CPT), which aims to reduce overall PTSD symptoms. Veterans who frequently feel guilty about their trauma and are not currently in similar therapy might be suitable candidates. The goal is to determine if TrIGR is as effective as the more resource-intensive CPT in improving symptoms of PTSD, depression, guilt, and shame. As an unphased trial, this study provides Veterans with a unique opportunity to explore innovative therapies that could significantly enhance their quality of life.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies on Trauma Informed Guilt Reduction Therapy (TrIGR) have shown promising safety results. Research indicates that individuals who received TrIGR experienced significant improvements in PTSD and depression symptoms without major safety concerns. The absence of specific negative effects suggests it is well-tolerated.

Cognitive Processing Therapy (CPT) also appears safe for most individuals. Studies have shown a low dropout rate, indicating participant comfort with the treatment. Participants in CPT have reported improvements in PTSD and depression symptoms, with no significant safety issues noted.

Both TrIGR and CPT seem well-tolerated based on available research, making them potentially safe options for those interested in these therapies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Trauma Informed Guilt Reduction Therapy (TrIGR) because it specifically targets trauma-related guilt and shame, which are often overlooked in traditional PTSD treatments like Cognitive Processing Therapy (CPT). While CPT focuses broadly on reducing PTSD symptoms, TrIGR zeroes in on the emotional burdens of guilt and shame that can exacerbate PTSD. By addressing these specific emotions, TrIGR has the potential to provide a more holistic healing experience for individuals struggling with PTSD.

What evidence suggests that this trial's treatments could be effective for PTSD?

This trial will compare Trauma Informed Guilt Reduction Therapy (TrIGR) with Cognitive Processing Therapy (CPT) for PTSD. Research has shown that TrIGR can lessen feelings of guilt related to trauma, as well as symptoms of PTSD and depression. Specifically, participants in TrIGR studies were more likely to no longer have PTSD and experienced significant improvements in depression symptoms.

For CPT, studies have found it effectively reduces PTSD symptoms. Patients often see a significant drop in their PTSD scores, and these improvements tend to last over time. Both treatments in this trial offer promising options for those dealing with PTSD and related issues. ^{1 2 3 6 7}

Who Is on the Research Team?

Sonya B. Norman, PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Processing Therapy
• Trauma Informed Guilt Reduction Therapy

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.

How Is the Trial Designed?

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

Cognitive Processing Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Cognitive Processing Therapy for:

• Posttraumatic Stress Disorder (PTSD)

Approved in European Union as Cognitive Processing Therapy for:

• Posttraumatic Stress Disorder (PTSD)

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

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]

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 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]

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]

Citations

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2589979124000027

Effectiveness of Cognitive Processing Therapy for PTSD in ...

This study provides promising data on the outcomes associated with a modified CPT protocol for treating PTSD in a high need but under-treated SMI population.

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pubmed.ncbi.nlm.nih.gov

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Cognitive Processing Therapy for Posttraumatic Stress ...

The CPT-TAU group showed a mean (SE) reduction in CAPS-5 scores of 14.00 (1.92) points, with a low dropout rate (2 of 29 [6.9%]). Patients in ...

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jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2829857

Cognitive Processing Therapy for Posttraumatic Stress ...

The CPT-TAU group maintained improvements in all outcomes from 17 to 34 weeks. Sensitivity analyses controlling for the types of traumatic ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/30332919/

A meta-analytic review of cognitive processing therapy for ...

These meta-analytic findings indicate that CPT is an effective PTSD treatment with lasting benefits across a range of outcomes.

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ptsd.va.gov

ptsd.va.gov/professional/treat/txessentials/cpt_for_ptsd_pro.asp

Cognitive Processing Therapy for PTSD

Participants in the active treatment conditions (both CPT and PE) demonstrated significant improvement in PTSD and depression over the course of treatment as ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3336190/

Long-Term Outcomes of Cognitive–Behavioral Treatments ...

CPT and PE resulted in lasting changes in PTSD and related symptoms over an extended period of time for female rape victims with extensive histories of trauma.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04230668

NCT04230668 | Cognitive Processing Therapy (CPT) for ...

A pilot effectiveness trial of cognitive processing therapy augmented with suicide risk management for individuals with comorbid PTSD and BPD conditions.