Guilt Reduction vs Exposure Therapy for PTSD

(PORT Trial)

Recruiting at 2 trial locations

Overseen By Kaitlyn Panza, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Veterans Medical Research Foundation

Disqualifiers: Severe substance use, Psychosis, Mania, others

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

Compensation: Varies

Number of Visits: 9

Duration: 6-12 weeks

158 Participants Needed

Trial Summary

What is the purpose of 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?

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Prolonged Exposure Therapy for PTSD?

Prolonged Exposure Therapy (PE) is a well-established treatment for PTSD, shown to be effective in reducing symptoms in various studies. Research indicates that PE can lead to significant improvements in PTSD symptoms, with a median effective dose of four sessions for veterans, and it is recognized as a leading treatment option for PTSD. ^{1 2 3 4 5}

Is Prolonged Exposure Therapy safe for humans?

Prolonged Exposure Therapy (PE) is a well-established treatment for PTSD and is generally considered safe for humans. It has been widely studied and used in various settings, including military and emergency services, without significant safety concerns reported. ^{1 2 4 5 6}

How does the treatment for PTSD in the Guilt Reduction vs Exposure Therapy trial differ from other treatments?

This treatment is unique because it combines Prolonged Exposure Therapy, which involves confronting trauma-related memories, with Trauma-Informed Guilt Reduction Therapy, which specifically targets feelings of guilt by helping patients understand their role in the trauma and re-engage with their values. This dual approach addresses both PTSD symptoms and trauma-related guilt, which is often not the primary focus in standard PTSD treatments. ^{1 4 5 7 8}

Research Team

Shannon Kehle-Forbes, PhD

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for veterans with PTSD who feel guilt or shame related to their trauma. Participants must be diagnosed with PTSD and have experienced a traumatic event that causes them feelings of guilt.

Inclusion Criteria

I am a U.S. Veteran aged 18 or older who served since OEF/OIF began.

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

I am willing to go to therapy and assessment sessions.

Exclusion Criteria

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

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) over 6 weekly sessions or Prolonged Exposure Therapy (PE) over 12 weekly sessions

6-12 weeks

6-12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 weeks

3 visits (in-person)

Treatment Details

Interventions

• Prolonged Exposure Therapy
• Trauma-Informed Guilt Reduction Therapy

Trial Overview The study compares Trauma-Informed Guilt Reduction (TrIGR) Therapy with Prolonged Exposure (PE) Therapy to see which is better at reducing PTSD symptoms, improving overall functioning, and lessening feelings of guilt and shame.

Participant Groups

Group I: trauma Informed Guilt Reduction Therapy Experimental Treatment 1 Intervention

6 session behavioral intervention focused on trauma-related guilt, shame, and moral injury

Group II: Prolonged Exposure Therapy Active Control 1 Intervention

12 session behavioral intervention focused on PTSD symptoms

Prolonged Exposure Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Prolonged Exposure Therapy for:

• Posttraumatic Stress Disorder (PTSD)

Approved in European Union as Prolonged Exposure Therapy for:

• Posttraumatic Stress Disorder (PTSD)

Who Is Running the Clinical Trial?

Veterans Medical Research Foundation

Lead Sponsor

Trials

46

Recruited

5,100+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Center for Veterans Research and Education

Collaborator

Trials

13

Recruited

1,700+

Findings from Research

Prolonged exposure therapy (PE) is recognized as the most scientifically validated treatment for post-traumatic stress disorder (PTSD), outperforming various pharmacological and psychotherapeutic options.

The therapy includes both imaginal and in vivo exposure techniques, and the paper discusses its effectiveness and dissemination specifically in Japan, highlighting its importance in treating chronic PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prolonged Exposure Therapy for Post-traumatic Stress Disorder]. Asukai, N.[2018]

A training workshop on prolonged exposure (PE) therapy for PTSD significantly improved the self-efficacy and outcome expectations of 45 psychologists, leading to increased use of PE techniques in their practice.

The study highlights the importance of combining training with intensive consultation to enhance the delivery of evidence-based PTSD treatments, suggesting that such approaches could help more emergency service patients receive effective care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training plus intensive consultation improves uptake and outcome expectations of prolonged exposure therapy among practitioners treating emergency service personnel with post-traumatic stress disorder. Wade, D., Terhaag, S., Putica, A., et al.[2021]

In a study involving 331 active duty U.S. military personnel with PTSD, prolonged exposure therapy (PE) significantly reduced trauma-related guilt across all treatment groups, indicating that active treatment can help alleviate feelings of guilt associated with trauma.

Baseline levels of trauma-related guilt did not predict the effectiveness of PTSD treatment, suggesting that individuals with varying levels of guilt can still benefit from PE and other therapeutic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guilt in the Treatment of Posttraumatic Stress Disorder Among Active Duty Military Personnel. McLean, CP., Zandberg, L., Brown, L., et al.[2020]

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]

Providers who received post-workshop consultation after a 4-day prolonged exposure therapy (PE) training reported significantly higher self-efficacy and used more components of PE, leading to better treatment delivery.

Patients treated by providers with post-workshop consultation experienced faster reductions in PTSD symptoms and lower severity at follow-up assessments, indicating that ongoing support for providers can enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a prolonged exposure workshop with and without consultation on provider and patient outcomes: a randomized implementation trial. Foa, EB., McLean, CP., Brown, LA., et al.[2022]

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

[Prolonged Exposure Therapy for Post-traumatic Stress Disorder]. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Training plus intensive consultation improves uptake and outcome expectations of prolonged exposure therapy among practitioners treating emergency service personnel with post-traumatic stress disorder. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Determining the median effective dose of prolonged exposure therapy for veterans with posttraumatic stress disorder. [2021]

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

Guilt in the Treatment of Posttraumatic Stress Disorder Among Active Duty Military Personnel. [2020]

5. Poland pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

The effects of a prolonged exposure workshop with and without consultation on provider and patient outcomes: a randomized implementation trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Combat-related guilt and the mechanisms of exposure therapy. [2019]

8. 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]