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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seeking Safety | Behavioral | SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annette Crisanti, Ph.D | University of New Mexico, Department of Psychiatry, Center for Rural and Community Behavioral Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inside Out | Española | New Mexico | 87532 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The analysis population included only those who had a baseline interview
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | baseline, 3 months |
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Peer Led | ## 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annette Crisanti, PhD | Department of Psychiatry and Behavioral Sciences, University of New Mexico | 505-850-7430 | acrisanti@salud.unm.edu |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D019966 | Substance-Related Disorders |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D064419 | Chemically-Induced Disorders |
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| baseline, 3 months |
| 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. | Baseline, 3-Month |
| baseline, 3 months |
| 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 | baseline, 3-Month |
| Incarcerated |
|
| Death |
|
| Withdrawal by Subject |
|
| Admitted to Residential Treatment |
|
| Did not start treatment |
|
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| 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 | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | baseline, 3 months |
|
|
|
| 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. | Number of Participants with an Addiction Severity Index Alcohol Composite Score greater than or equal to median of 0.0111. | Posted | Number | participants | baseline, 3 months |
|
|
|
| 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. | Frequency of participants greater than or equal to median ASI Drug Composite Score 0.1077 | Posted | Number | participants | Baseline, 3-Month |
|
|
|
| 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 | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | baseline, 3 months |
|
|
|
| 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 | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | baseline, 3-Month |
|
|
|
| 4 |
| 146 |
| 0 |
| 146 |
| 0 |
| 146 |
| EG001 | Clinician Led | # 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. | 3 | 145 | 0 | 145 | 0 | 145 |
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