Trial Outcomes & Findings for Effectiveness of Peer-Delivered Trauma-Specific Treatment (NCT NCT02081417)
NCT ID: NCT02081417
Last Updated: 2019-06-10
Results Overview
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).
COMPLETED
NA
291 participants
baseline, 3 months
2019-06-10
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
163
|
166
|
|
Overall Study
1st Interview Completed
|
146
|
145
|
|
Overall Study
3-Month Follow-Up
|
94
|
95
|
|
Overall Study
6-Month Follow-Up
|
82
|
92
|
|
Overall Study
COMPLETED
|
107
|
115
|
|
Overall Study
NOT COMPLETED
|
56
|
51
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
26
|
23
|
|
Overall Study
Moved Away
|
1
|
2
|
|
Overall Study
Incarcerated
|
2
|
2
|
|
Overall Study
Death
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
|
Overall Study
Admitted to Residential Treatment
|
2
|
0
|
|
Overall Study
Did not start treatment
|
17
|
21
|
Baseline Characteristics
Effectiveness of Peer-Delivered Trauma-Specific Treatment
Baseline characteristics by cohort
| Measure |
Peer Led
n=146 Participants
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.
|
Clinician Led
n=145 Participants
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.
|
Total
n=291 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 10 • n=99 Participants
|
35 years
STANDARD_DEVIATION 12 • n=107 Participants
|
35 years
STANDARD_DEVIATION 11 • n=206 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
129 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
162 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
124 Participants
n=99 Participants
|
121 Participants
n=107 Participants
|
245 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
17 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=99 Participants
|
90 Participants
n=107 Participants
|
176 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
31 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline, 3 monthsPTSD 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).
Outcome measures
| Measure |
Peer Led
n=146 Participants
Seeking Safety Intervention Led by the Peer Providers
Seeking Safety: SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs.
|
Clinician Led
n=145 Participants
Seeking Safety Intervention Led by the Clinicians
Seeking Safety: SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs.
|
|---|---|---|
|
Change in Post-traumatic Stress Disorder Symptoms
Baseline
|
47.2 Score on a Scale
Interval 43.3 to 51.1
|
48.2 Score on a Scale
Interval 44.3 to 52.1
|
|
Change in Post-traumatic Stress Disorder Symptoms
3-Month Follow-Up
|
43.9 Score on a Scale
Interval 39.7 to 48.1
|
44.7 Score on a Scale
Interval 40.5 to 48.8
|
PRIMARY outcome
Timeframe: baseline, 3 monthsThe 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
Outcome measures
| Measure |
Peer Led
n=146 Participants
Seeking Safety Intervention Led by the Peer Providers
Seeking Safety: SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs.
|
Clinician Led
n=145 Participants
Seeking Safety Intervention Led by the Clinicians
Seeking Safety: SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs.
|
|---|---|---|
|
Change in Coping Skills
Baseline
|
45.7 Score on a Scale
Interval 41.9 to 49.4
|
46.5 Score on a Scale
Interval 42.8 to 50.2
|
|
Change in Coping Skills
3-Month Follow-Up
|
48.6 Score on a Scale
Interval 44.5 to 52.7
|
48.3 Score on a Scale
Interval 44.2 to 52.4
|
SECONDARY outcome
Timeframe: baseline, 3 monthsPopulation: Number of Participants with an Addiction Severity Index Alcohol Composite Score greater than or equal to median of 0.0111.
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.
Outcome measures
| Measure |
Peer Led
n=146 Participants
Seeking Safety Intervention Led by the Peer Providers
Seeking Safety: SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs.
|
Clinician Led
n=145 Participants
Seeking Safety Intervention Led by the Clinicians
Seeking Safety: SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs.
|
|---|---|---|
|
Change in Substance Use - Alcohol Use
Baseline
|
52 participants
|
55 participants
|
|
Change in Substance Use - Alcohol Use
3-Month Follow-Up
|
28 participants
|
36 participants
|
SECONDARY outcome
Timeframe: Baseline, 3-MonthPopulation: Frequency of participants greater than or equal to median ASI Drug Composite Score 0.1077
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.
Outcome measures
| Measure |
Peer Led
n=146 Participants
Seeking Safety Intervention Led by the Peer Providers
Seeking Safety: SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs.
|
Clinician Led
n=145 Participants
Seeking Safety Intervention Led by the Clinicians
Seeking Safety: SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs.
|
|---|---|---|
|
Change in Substance Use - Drug Use
Baseline
|
58 participants
|
58 participants
|
|
Change in Substance Use - Drug Use
3-Month Follow-up
|
24 participants
|
31 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 3 monthsOverall 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
Outcome measures
| Measure |
Peer Led
n=146 Participants
Seeking Safety Intervention Led by the Peer Providers
Seeking Safety: SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs.
|
Clinician Led
n=145 Participants
Seeking Safety Intervention Led by the Clinicians
Seeking Safety: SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs.
|
|---|---|---|
|
Change in Overall Mental Health
Basline
|
36.3 Score on a Scale
Interval 33.3 to 39.3
|
35.7 Score on a Scale
Interval 32.7 to 38.7
|
|
Change in Overall Mental Health
3-Month Follow-Up
|
41.2 Score on a Scale
Interval 37.8 to 44.5
|
40.2 Score on a Scale
Interval 36.9 to 43.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 3-MonthOverall 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
Outcome measures
| Measure |
Peer Led
n=146 Participants
Seeking Safety Intervention Led by the Peer Providers
Seeking Safety: SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs.
|
Clinician Led
n=145 Participants
Seeking Safety Intervention Led by the Clinicians
Seeking Safety: SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs.
|
|---|---|---|
|
Change in Overall Physical Health
Baseline
|
50.8 Score on a Scale
Interval 48.6 to 52.9
|
52.7 Score on a Scale
Interval 50.6 to 54.9
|
|
Change in Overall Physical Health
3-Month Follow-Up
|
50.2 Score on a Scale
Interval 47.8 to 52.5
|
51.5 Score on a Scale
Interval 49.2 to 53.8
|
Adverse Events
Peer Led
Clinician Led
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Annette Crisanti, PhD
Department of Psychiatry and Behavioral Sciences, University of New Mexico
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place