This trial is active, not recruiting.

Conditions post-traumatic stress disorder, substance use disorders
Treatment seeking safety
Sponsor University of New Mexico
Collaborator Patient-Centered Outcomes Research Institute
Start date October 2013
End date December 2016
Trial size 291 participants
Trial identifier NCT02081417, 4484


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
## 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)
seeking safety
SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs.
# 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).
seeking safety
SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs.

Primary Outcomes

Change in Post-traumatic Stress Disorder Symptoms
time frame: baseline, 3 months

Secondary Outcomes

Change in substance use
time frame: baseline, 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Patient-Centered Trauma Treatment for PTSD and Substance Abuse: Is it an Effective Treatment Option?
Principal investigator Annette Crisanti, Ph.D
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of New Mexico.