- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02081417
Effectiveness of Peer-Delivered Trauma-Specific Treatment
Patient-Centered Trauma Treatment for PTSD and Substance Abuse: Is it an Effective Treatment Option?
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Mexico
-
Española, New Mexico, United States, 87532
- Inside Out
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Peer led
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)
|
SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs.
|
Other: Clinician led
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).
|
SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Post-traumatic Stress Disorder Symptoms
Time Frame: baseline, 3 months
|
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
Time Frame: baseline, 3 months
|
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
Time Frame: baseline, 3 months
|
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
Time Frame: Baseline, 3-Month
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Overall Mental Health
Time Frame: baseline, 3 months
|
Overall mental health and physical health will be assessed by the subscales of the SF-36 (short form 36). The SF-36 questions measure functional health and well-being from the patient's point of view.
It is a practical, reliable, and valid measure of mental and physical health that can be completed in five to 10 minutes.
The SF-36 has proven useful in differentiating the health benefits produced by different treatments.
The Component Summary Scores range from 0% to 100% with higher scores indicative of higher functioning
|
baseline, 3 months
|
Change in Overall Physical Health
Time Frame: baseline, 3-Month
|
Overall mental health and physical health will be assessed by the subscales of the SF-36 (short form 36). The SF-36 questions measure functional health and well-being from the patient's point of view.
It is a practical, reliable, and valid measure of mental and physical health that can be completed in five to 10 minutes.
The Component Summary Scores range from 0% to 100% with higher scores indicative of higher functioning
|
baseline, 3-Month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Annette Crisanti, Ph.D, University of New Mexico, Department of Psychiatry, Center for Rural and Community Behavioral Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4484
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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