Clinical trial NCT02081417: Effectiveness of Peer-Delivered Trauma-Specific Treatment
Official title: Patient-Centered Trauma Treatment for PTSD and Substance Abuse: Is it an Effective Treatment Option?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Substance Use Disorders
Keywords: Trauma
Post traumatic stress disorder
substance use disorders
peer-delivered trauma treatment
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-03-07
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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:

1. 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.
2. 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.
3. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Post-traumatic Stress Disorder Symptoms
timeFrame: baseline, 3 months
measure: Change in Coping Skills
timeFrame: baseline, 3 months
Secondary outcomes:
measure: Change in Substance Use - Alcohol Use
timeFrame: baseline, 3 months
measure: Change in Substance Use - Drug Use
timeFrame: Baseline, 3-Month
Other outcomes:
measure: Change in Overall Mental Health
timeFrame: baseline, 3 months
measure: Change in Overall Physical Health
timeFrame: baseline, 3-Month
Locations:
city: Española
country: United States
facility: Inside Out
state: New Mexico
Study officials:
affiliation: University of New Mexico, Department of Psychiatry, Center for Rural and Community Behavioral Health
name: Annette Crisanti, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: