Written Exposure Therapy for PTSD

Overseen By Christal Badour, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jesse McCann

Must be taking: Methadone, Buprenorphine

Disqualifiers: Psychotic disorders, Dissociative identity, others

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

Compensation: Varies

Number of Visits: 6

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Written Exposure Therapy - Integrated (WET-I) for individuals with both PTSD and opioid use disorder (OUD). The researchers aim to determine if WET-I can effectively reduce symptoms of PTSD, anxiety, and depression, while also monitoring changes in drug use and cravings. Participants will attend five weekly sessions of WET-I, addressing both trauma and substance use issues. This trial may suit individuals who have experienced trauma, currently have or have had OUD, and are enrolled in a methadone or buprenorphine treatment program in Kentucky. As an unphased trial, the study offers a unique opportunity to explore a new therapeutic approach for managing PTSD and OUD symptoms.

Will I have to stop taking my current medications?

You can continue taking your current medications for opioid use disorder (like methadone or buprenorphine) as long as your dosage has been stable for at least 4 weeks before the study and remains stable during the study. The trial does not specify stopping other medications, but you should maintain a stable dosage throughout the study period.

What prior data suggests that Written Exposure Therapy - Integrated is safe for individuals with PTSD and OUD?

Research shows that Written Exposure Therapy (WET) is a well-accepted treatment for posttraumatic stress disorder (PTSD). Studies have found that WET works well even for individuals with complex issues, such as substance use problems. Many people with PTSD and other challenges have used WET without major issues.

WET is a short-term therapy that typically involves writing about traumatic events over a few sessions. This method helps reduce PTSD symptoms and improves emotional management. Because WET is safe and simple, it requires minimal training for therapists and is easier for patients.

Additionally, WET has shown positive results in similar situations. Patients generally report satisfaction and continue with the treatment, suggesting that people find WET to be a reliable and helpful option. Overall, evidence supports that WET is a safe and effective treatment for PTSD, making it a promising choice for those in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Written Exposure Therapy - Integrated (WET-I) for PTSD because it offers a novel, non-pharmacological approach to treatment. Unlike traditional PTSD treatments, such as prolonged exposure therapy or cognitive processing therapy, WET-I simplifies the process by focusing on written expression, which can be less intimidating and more accessible for some patients. Additionally, WET-I requires fewer sessions, potentially reducing the time and cost involved in therapy. This could make it a more appealing option for individuals seeking effective, yet efficient, treatment for PTSD.

What evidence suggests that Written Exposure Therapy - Integrated might be an effective treatment for PTSD?

Research has shown that Written Exposure Therapy (WET) effectively treats PTSD. Studies have found that WET works well even for individuals with complicated cases and other mental health issues. Veterans with PTSD have experienced significant symptom improvement with WET. This therapy also maintains good retention rates, meaning participants are more likely to continue with it. This is crucial for those with both PTSD and opioid use disorder, as consistent treatment can lead to better outcomes. Overall, WET is a promising option for managing PTSD, especially when combined with treatments for substance use. Participants in this trial will receive Written Exposure Therapy - Integrated (WET-I) after either a 3-week or 5-week baseline period, followed by a 4-week follow-up phase. ^{2 3 6 7 8}

Who Is on the Research Team?

Christal Badour, PhD

Principal Investigator

University of Kentucky

Jesse McCann, MS

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have experienced trauma, are diagnosed with PTSD and opioid use disorder (OUD), can read and write in English, and are currently enrolled in a methadone or buprenorphine program in Kentucky. They must not be undergoing other trauma-focused treatments and should maintain stable doses of any psychotropic or OUD medications.

Inclusion Criteria

History of trauma meeting past-month diagnostic criteria for posttraumatic stress disorder (PTSD) and current or past diagnostic criteria for opioid use disorder (OUD)

Participants in this study will also be required to sign a release of medical information for their methadone or buprenorphine clinic so that study staff can coordinate care with their methadone or buprenorphine provider

I am enrolled in a methadone or buprenorphine program in Kentucky.

Exclusion Criteria

Individuals who endorse factors for which the treatment being studied (WET-I) may be contraindicated. These factors may include having no or limited memory of the trauma that would prevent the individual from engaging in written exposures

I have a psychological condition that might need different treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (telehealth or in-person)

Baseline

Participants complete weekly assessments of PTSD symptoms, anxiety, depression, quality of life, and substance use

3-5 weeks

Weekly assessments (telehealth or in-person)

Treatment

Participants receive 5 weekly sessions of Written Exposure Therapy - Integrated (WET-I) with weekly assessments

5 weeks

5 visits (telehealth or in-person)

Follow-up

Participants are monitored for changes in PTSD symptoms, anxiety, depression, and substance use

4 weeks

Weekly assessments (telehealth or in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Written Exposure Therapy - Integrated

Trial Overview The study tests Written Exposure Therapy-Integrated (WET-I) combined with harm reduction skills among patients receiving medication for OUD. It aims to see if this five-session treatment can reduce PTSD symptoms without increasing substance cravings or use, using weekly sessions over a one-month follow-up period.

How Is the Trial Designed?

Group I: 5-Week Baseline Experimental Treatment 1 Intervention

Participants in this arm are randomized to a 5-week baseline period with repeated weekly assessment after the initial intake. Following the 5-week baseline, participants receive 5 weekly sessions of Written Exposure Therapy - Integrated (WET-I) followed by a 4-week follow-up phase with repeated weekly assessments.

Group II: 3-Week Baseline Experimental Treatment 1 Intervention

Participants in this arm are randomized to a 3-week baseline period with repeated weekly assessment after the initial intake. Following the 3-week baseline, participants receive 5 weekly sessions of Written Exposure Therapy - Integrated (WET-I) followed by a 4-week follow-up phase with repeated weekly assessments.

Who Is Running the Clinical Trial?

Jesse McCann

Lead Sponsor

Trials

2

Recruited

20+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34726451/

Effectiveness of written exposure therapy for posttraumatic ... WET was an effective approach across a range of patient characteristics in this sample of veterans with PTSD. WET was also effective whether ...

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

Written Exposure Therapy for PTSD - PTSD: National ... A growing number of studies indicate that WET is effective for PTSD, even among patients with complicated presentations and other comorbid disorders.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05421494?cond=PTSD&rank=4

The Effectiveness of Written Exposure Therapy for PTSD Study 1: The goal of this study is to use a pilot RCT to assess the effectiveness of Written Exposure Therapy (WET) and a mindfulness-based app (MBA) for ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666560323000713

Supporting the implementation of written exposure therapy ... This paper presents implementation process outcomes of Written Exposure Therapy (WET), a brief, scalable, and sustainable evidence-based PTSD treatment ...

5. mdpi.com mdpi.com/2076-328X/15/7/877

Written Exposure Therapy for PTSD Integrated with ... CUD is associated with more severe PTSD symptoms and other mental health comorbidities including depression, suicidality, and emotion dysregulation. Addressing ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6487906/

Efficacy of Integrated Exposure Therapy vs ... Integrated prolonged exposure therapy was well tolerated and had greater efficacy for reducing posttraumatic stress disorder symptoms than ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01800773

Written Exposure Therapy for Posttraumatic Stress Disorder Outcome data will be collected at baseline and 6-, 12-, 24-, 36- and 60-weeks post-first treatment session. The primary aim is to examine whether PTSD ...

8. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/1346186

Integrated Exposure-Based Therapy for Co-occurring ... As in the present study, both groups demonstrated significant improvements in PTSD and substance dependence symptoms; however, no between-group ...