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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two therapies for veterans with PTSD who experience significant guilt related to their trauma. It compares Trauma-Informed Guilt Reduction Therapy, which targets guilt and shame, with Prolonged Exposure Therapy (also known as Exposure Therapy), which focuses on reducing PTSD symptoms. The goal is to determine if the new therapy is as effective in reducing PTSD symptoms and depression, and possibly more effective at easing feelings of guilt and shame. Veterans who have served since Operation Enduring Freedom/Operation Iraqi Freedom and experience trauma-related guilt might be a good fit. As an unphased trial, this study offers veterans the chance to explore innovative therapies that could significantly improve their mental health and well-being.

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.

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

A previous study found prolonged exposure therapy to be very effective for treating PTSD, with success rates between 65% and 80%. This well-known therapy has been tested with many veterans, showing improvements in PTSD symptoms. These studies reported no major safety issues, suggesting it is generally well-tolerated.

For Trauma-Informed Guilt Reduction Therapy (TrIGR), research shows that nearly half of the participants experienced noticeable reductions in PTSD symptoms after treatment. Reductions in trauma-related guilt were linked to lower PTSD and depression symptoms, indicating positive results. While specific safety data is limited, the therapy involves only a few sessions and focuses on emotional support, which generally suggests it is well-tolerated.

Overall, both therapies have demonstrated effectiveness and are considered safe options for addressing PTSD and related issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Trauma-Informed Guilt Reduction Therapy because it targets trauma-related guilt, shame, and moral injury, offering a fresh angle compared to traditional PTSD treatments like Prolonged Exposure Therapy. This new therapy is unique because it requires only six sessions, potentially making it a more accessible and quicker option for patients. Additionally, by focusing specifically on emotions that aren't always addressed in standard treatments, it could provide relief for those who haven't fully benefited from existing methods.

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

This trial will compare Prolonged Exposure Therapy and Trauma-Informed Guilt Reduction Therapy (TrIGR) for treating PTSD. Research has shown that Prolonged Exposure Therapy is highly effective for PTSD, with studies reporting significant symptom improvement in 65% to 80% of participants. One study found this therapy more effective than being on a waiting list and as effective as other trauma-focused treatments.

Trauma-Informed Guilt Reduction Therapy (TrIGR), another treatment option in this trial, has shown promise in reducing trauma-related guilt and PTSD symptoms. Research found it led to greater reductions in guilt, depression, and PTSD symptoms compared to other treatments. It addresses distress that other therapies might not cover, potentially offering additional benefits. ^{1 2 6 7 8}

Who Is on the Research Team?

Shannon Kehle-Forbes, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

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 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) 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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK79056/

A meta-analytic review of prolonged exposure for ... - NCBI - NIH Prolonged exposure therapy was highly effective in treating post-traumatic stress disorder and significantly more effective than inactive (waiting list) and ...

2. ptsd.va.gov ptsd.va.gov/professional/treat/txessentials/prolonged_exposure_pro.asp

Prolonged Exposure for PTSD - PTSD: National Center for ... In an RCT of 916 veterans randomized to PE or another trauma focused treatment, Cognitive Processing Therapy (CPT), PTSD symptoms improved in both treatments.

3. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2808302

Written Exposure Therapy vs Prolonged ... Conclusions and Relevance In this study, WET was noninferior to PE in PTSD symptom change and was associated with significantly less attrition.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2451865422000576

Enhancing Prolonged Exposure therapy for PTSD using ... Prolonged Exposure (PE) therapy is one of the most effective treatments for PTSD, with response rates ranging from 65 to 80% [[9], [10], [11]].

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10721715/

Treatment of Posttraumatic Stress Disorder with Prolonged ... In a pilot study, PE-PC showed significant and large reductions in PTSD from pre- to post-treatment that were maintained at six-month follow-up (Cigrang et al., ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT00057629

Prolonged Exposure Therapy for Post Traumatic Stress ... This study will evaluate the effectiveness of a brief cognitive behavioral therapy, administered by community agencies, for the treatment of patients with Post ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9160482/

Enhancing Prolonged Exposure therapy for PTSD using ... Prolonged Exposure (PE) therapy is one of the most effective treatments for PTSD, with response rates ranging from 65 to 80% [[9], [10], [11]].

8. researchgate.net researchgate.net/profile/Carmen-Mclean-2/publication/380033370_State_of_the_Science_Prolonged_exposure_therapy_for_the_treatment_of_posttraumatic_stress_disorder/links/6639471b06ea3d0b742ca985/State-of-the-Science-Prolonged-exposure-therapy-for-the-treatment-of-posttraumatic-stress-disorder.pdf

State of the Science: Prolonged exposure therapy for the ... Prolonged exposure therapy (PE) is a well-established first-line treatment for posttraumatic stress disorder (PTSD) that is based on emotional ...