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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

291 participants

Primary outcome timeframe

baseline, 3 months

Results posted on

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

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

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

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 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).

Outcome measures

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 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

Outcome measures

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 months

Population: 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

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-Month

Population: 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

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 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

Outcome measures

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-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

Outcome measures

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths

Clinician Led

Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths

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

Phone: 505-850-7430

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place