Effectiveness of Peer-Delivered Trauma-Specific Treatment

NCT02081417 | Completed Results

• 1 other identifier: 4484
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

Conditions

Post-Traumatic Stress Disorder; Substance Use Disorders

Keywords

Trauma; Post traumatic stress disorder; substance use disorders; peer-delivered trauma treatment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Substance Use - Alcohol Use

  baseline, 3 months

• Change in Substance Use - Drug Use

  Baseline, 3-Month

Other Outcomes (2)

• Change in Overall Mental Health

  baseline, 3 months

• Change in Overall Physical Health

  baseline, 3-Month

Study Arms (2)

Peer led

OTHER

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

Clinician led

OTHER

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

Interventions

Seeking Safety BEHAVIORAL

SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs.

Clinician led; Peer led

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Live outside of catchment area
• Suicidal
• Pending immediate incarceration

Sponsors & Collaborators

• University of New Mexico: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Inside Out

Española, New Mexico, 87532, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Substance-Related Disorders; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders

Results Point of Contact

• Title: Annette Crisanti, PhD
• Organization: Department of Psychiatry and Behavioral Sciences, University of New Mexico

acrisanti@salud.unm.edu

505-850-7430

Study Officials

• Annette Crisanti, Ph.D

  University of New Mexico, Department of Psychiatry, Center for Rural and Community Behavioral Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: March 7, 2014
• Study Start: October 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: June 10, 2019
• Results First Posted: June 10, 2019

Record last verified: 2019-03

Locations

US (1)