Effectiveness of Peer-Delivered Trauma-Specific Treatment

Study Overview
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Brief Summary
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Patient-Centered Trauma Treatment, i.e., treatment delivered by peers with lived-experience, has the potential to increase access to trauma treatment in underserved communities. This could positively impact the lives of millions of people as 70% of adults in the U.S have experienced a traumatic event and the consequences of trauma are devastating and far reaching, including chronic and comorbid physical and mental health problems. The most known consequences of trauma include post-traumatic stress disorder (PTSD) and substance use disorders (SUDs). Seeking Safety (SS) is the most effective evidenced-based treatment for co-occurring trauma, PTSD and SUDs. While no specific degree or experience level is required to conduct SS, all the evidence comes from studies using trained clinicians to implement the treatment, including social workers, psychologists, and psychiatrists. However, these research findings do not generalize to underserved communities that lack mental health professionals. Innovative approaches to treatment, such as peer-delivered services, are required to meet the demand for care in underserved areas. While the benefits of peer-delivered services have been well-documented in many areas, the value of peers in the provision of trauma-treatment is unknown. A theoretical basis supports the potential for peer-delivered trauma-treatment to be effective in addition to the strong therapist-patient bond, (i.e. therapeutic alliance (TA), which is an important predictor of treatment outcome and a typical result of peer-patient relationships. Our research question is whether there is a difference between peer-led SS (PL-SS) groups and clinician-led SS (CL-SS) groups in improving the lives of people with trauma, PTSD and SUDs? The investigators have three specific aims: Determine the effectiveness of PL-SS groups compared to CL-SS groups in decreasing substance use and PTSD symptoms and improving coping skills, overall mental health and physical health. Hypothesis: PL-SS compared to CL-SS groups will be as effective in improving outcomes. Compare levels of TA among PL-SS and CL-SS groups and examine the impact of TA on outcomes.Hypotheses: Levels of TA will be higher and will play more of a role in impacting outcomes in the PL-SS compared to CL-SS groups. Determine if the standard Seeking Safety Instructor Training (SS-IT) is adequate for peers. Hypothesis: Peers will identify topics that will enhance the SS-IT.

Official Title
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Patient-Centered Trauma Treatment for PTSD and Substance Abuse: Is it an Effective Treatment Option?

Conditions
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Post-Traumatic Stress Disorder, Substance Use Disorders

Intervention / Treatment
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* Behavioral: Seeking Safety


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be a member of INSIDE OUT, a peer-run wellness center Be at least 18 years old Have a history of trauma Meet DSM-IV diagnostic criteria for lifetime and current full or sub-threshold PTSD Meet DSM-IV diagnostic criteria for current substance abuse or dependence Be able to provide informed consent to participate in the study. Exclusion Criteria: Live outside of catchment area Suicidal Pending immediate incarceration

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Peer led<br>Number sessions of the intervention of an evidenced based practice called Seeking Safety led by a Peer (6 sessions will be used to define treatment completion) | Behavioral: Seeking Safety<br>* SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs.<br>|
| Other: Clinician led<br>Number intervention groups of an evidence based practice called Seeking Safety led by a master's level Clinician (6 sessions will be used to define treatment completion). | Behavioral: Seeking Safety<br>* SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Post-traumatic Stress Disorder Symptoms | PTSD Symptoms will be measured by the post-traumatic symptom checklist - civilian version. Responses are summed to yield a total severity score, with the full range for total scores being 17 to 85 (higher scores mean higher severity). | baseline, 3 months | 
| Change in Coping Skills | The Coping Scale will be used to assess coping skills. The Coping Scale directly assesses the degree to which participants report using 17 specific coping skills from SS, scaled from 0 (not at all) to 5 (extremely). This scale was selected as it is the most widely used measure of coping in the SS literature. As a result we will be able to directly compare our findings to other studies. Higher scores indicate greater frequency of use of coping skills with the range of total scores being 0 to 90 | baseline, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Substance Use - Alcohol Use | Drug and alcohol problem severity will be assessed using the drug and alcohol subscales of the Addiction Severity Index (ASI). Items assess frequency of drug and alcohol use and abuse within the past 30 days, how bothered the individual is by his/her drug or alcohol problems, and the importance of treatment. Higher composite scores indicate more severe problems. The ASI questions focus on two distinct time periods: the past 30 days and lifetime. A number of studies have confirmed the reliability and validity of the ASI. | baseline, 3 months | 
| Change in Substance Use - Drug Use | Drug and alcohol problem severity will be assessed using the drug and alcohol subscales of the Addiction Severity Index (ASI). Items assess frequency of drug and alcohol use and abuse within the past 30 days, how bothered the individual is by his/her drug or alcohol problems, and the importance of treatment. Higher composite scores indicate more severe problems. The ASI questions focus on two distinct time periods: the past 30 days and lifetime. A number of studies have confirmed the reliability and validity of the ASI. | Baseline, 3-Month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trauma, Post traumatic stress disorder, substance use disorders, peer-delivered trauma treatment