Post-Traumatic Stress Disorder, Substance Use Disorders
Conditions
Keywords
Trauma, Post traumatic stress disorder, substance use disorders, peer-delivered trauma 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.
Interventions
BEHAVIORALSeeking Safety
SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs.
Sponsors
Patient-Centered Outcomes Research Institute
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Post-traumatic Stress Disorder Symptoms | 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). |
| Change in Coping Skills | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Substance Use - Alcohol Use | 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. |
| Change in Substance Use - Drug Use | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Overall Mental Health | 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 |
| Change in Overall Physical Health | 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 |
Countries
United States
Participant flow
Pre-assignment details
Because of this difficult to engage population, participants were consented and baseline data collected after they were randomized to a study arm and completed their first treatment group.
Participants by arm
| Arm | Count |
|---|---|
| Peer Led Number of 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. | 146 |
| Clinician Led Number of 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. | 145 |
| Total | 291 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Admitted to Residential Treatment | 2 | 0 |
| Overall Study | Death | 4 | 3 |
| Overall Study | Did not start treatment | 17 | 21 |
| Overall Study | Incarcerated | 2 | 2 |
| Overall Study | Lost to Follow-up | 26 | 23 |
| Overall Study | Moved Away | 1 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 0 |
Baseline characteristics
| Characteristic | Clinician Led | Total | Peer Led |
|---|---|---|---|
| Age, Continuous | 35 years STANDARD_DEVIATION 12 | 35 years STANDARD_DEVIATION 11 | 35 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 121 Participants | 245 Participants | 124 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 46 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 16 Participants | 33 Participants | 17 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 18 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 27 Participants | 58 Participants | 31 Participants |
| Race (NIH/OMB) White | 90 Participants | 176 Participants | 86 Participants |
| Sex: Female, Male Female | 62 Participants | 129 Participants | 67 Participants |
| Sex: Female, Male Male | 83 Participants | 162 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 146 | 3 / 145 |
| other Total, other adverse events | 0 / 146 | 0 / 145 |
| serious Total, serious adverse events | 0 / 146 | 0 / 145 |
Outcome results
Primary
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
Time frame: baseline, 3 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Peer Led | Change in Coping Skills | 3-Month Follow-Up | 48.6 Score on a Scale |
| Peer Led | Change in Coping Skills | Baseline | 45.7 Score on a Scale |
| Clinician Led | Change in Coping Skills | Baseline | 46.5 Score on a Scale |
| Clinician Led | Change in Coping Skills | 3-Month Follow-Up | 48.3 Score on a Scale |
Primary
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).
Time frame: baseline, 3 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Peer Led | Change in Post-traumatic Stress Disorder Symptoms | Baseline | 47.2 Score on a Scale |
| Peer Led | Change in Post-traumatic Stress Disorder Symptoms | 3-Month Follow-Up | 43.9 Score on a Scale |
| Clinician Led | Change in Post-traumatic Stress Disorder Symptoms | Baseline | 48.2 Score on a Scale |
| Clinician Led | Change in Post-traumatic Stress Disorder Symptoms | 3-Month Follow-Up | 44.7 Score on a Scale |
p-value: 0.0195% CI: [-3.4, 3.8]Mixed Models Analysis
Secondary
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.
Time frame: baseline, 3 months
Population: Number of Participants with an Addiction Severity Index Alcohol Composite Score greater than or equal to median of 0.0111.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peer Led | Change in Substance Use - Alcohol Use | Baseline | 52 participants |
| Peer Led | Change in Substance Use - Alcohol Use | 3-Month Follow-Up | 28 participants |
| Clinician Led | Change in Substance Use - Alcohol Use | Baseline | 55 participants |
| Clinician Led | Change in Substance Use - Alcohol Use | 3-Month Follow-Up | 36 participants |
Secondary
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.
Time frame: Baseline, 3-Month
Population: Frequency of participants greater than or equal to median ASI Drug Composite Score 0.1077
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peer Led | Change in Substance Use - Drug Use | Baseline | 58 participants |
| Peer Led | Change in Substance Use - Drug Use | 3-Month Follow-up | 24 participants |
| Clinician Led | Change in Substance Use - Drug Use | Baseline | 58 participants |
| Clinician Led | Change in Substance Use - Drug Use | 3-Month Follow-up | 31 participants |
Other Pre-specified
Change in Overall Mental Health
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
Time frame: baseline, 3 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Peer Led | Change in Overall Mental Health | Basline | 36.3 Score on a Scale |
| Peer Led | Change in Overall Mental Health | 3-Month Follow-Up | 41.2 Score on a Scale |
| Clinician Led | Change in Overall Mental Health | Basline | 35.7 Score on a Scale |
| Clinician Led | Change in Overall Mental Health | 3-Month Follow-Up | 40.2 Score on a Scale |
Other Pre-specified
Change in Overall Physical Health
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
Time frame: baseline, 3-Month
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Peer Led | Change in Overall Physical Health | Baseline | 50.8 Score on a Scale |
| Peer Led | Change in Overall Physical Health | 3-Month Follow-Up | 50.2 Score on a Scale |
| Clinician Led | Change in Overall Physical Health | Baseline | 52.7 Score on a Scale |
| Clinician Led | Change in Overall Physical Health | 3-Month Follow-Up | 51.5 Score on a Scale |