Trial Outcomes & Findings for Implementing a Skills Training Evidence-Based Treatment for Posttraumatic Stress Disorder in Primary Care (NCT NCT04937504)

Last Updated: 2025-02-14

Results Overview

The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms. The PCL-5 scale ranges from Not At All (0) to Extremely (4) so the PTSD checklist total scores can range from 0 to 80, where higher scores indicate higher severity of PTSD symptoms.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

Baseline, 15 weeks, and 9 months

Results posted on

2025-02-14

Participant Flow

Participant milestones

Participant milestones
Measure	STAIR-PC Group Participants in the Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) group will complete five (30 minute each) therapist-led sessions in-person or via Telehealth for up to 15 weeks.	WebSTAIR Group Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks.
Baseline STARTED	31	29
Baseline COMPLETED	31	29
Baseline NOT COMPLETED	0	0
15 Weeks Assessment STARTED	31	29
15 Weeks Assessment COMPLETED	26	20
15 Weeks Assessment NOT COMPLETED	5	9
9 Months Assessment STARTED	26	20
9 Months Assessment COMPLETED	23	18
9 Months Assessment NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	STAIR-PC Group Participants in the Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) group will complete five (30 minute each) therapist-led sessions in-person or via Telehealth for up to 15 weeks.	WebSTAIR Group Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks.
15 Weeks Assessment Lost to Follow-up	5	9
9 Months Assessment Lost to Follow-up	3	2

Baseline Characteristics

Implementing a Skills Training Evidence-Based Treatment for Posttraumatic Stress Disorder in Primary Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	STAIR-PC Group n=31 Participants Participants in the Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) group will complete five (30 minute each) therapist-led sessions in-person or via Telehealth for up to 15 weeks.	WebSTAIR Group n=29 Participants Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks.	Total n=60 Participants Total of all reporting groups
Age, Continuous	35.69 years STANDARD_DEVIATION 14.95 • n=5 Participants	36.28 years STANDARD_DEVIATION 10.57 • n=7 Participants	35.97 years STANDARD_DEVIATION 12.92 • n=5 Participants
Sex/Gender, Customized Male	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Sex/Gender, Customized Female	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Sex/Gender, Customized Queer/Non Binary/Other	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex/Gender, Customized Declined to answer	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	29 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 15 weeks, and 9 months

Population: Refer to participant flow for numbers of participants analyzed at baseline, 15 weeks, and 9 months assessments.

Outcome measures

Outcome measures
Measure	STAIR-PC Group n=31 Participants Participants in the Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) group will complete five (30 minute each) therapist-led sessions in-person or via Telehealth for up to 15 weeks.	WebSTAIR Group n=29 Participants Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks.
Posttraumatic Stress Disorder Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5) Baseline	61.48 score on a scale Standard Deviation 10.18	58.28 score on a scale Standard Deviation 10.73
Posttraumatic Stress Disorder Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5) 15 weeks	39.12 score on a scale Standard Deviation 22.32	36.30 score on a scale Standard Deviation 19.91
Posttraumatic Stress Disorder Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5) 9 months	28.04 score on a scale Standard Deviation 21.61	36.39 score on a scale Standard Deviation 18.38

PRIMARY outcome

Timeframe: 15 weeks

Population: An intent to treat analysis was done at 15 weeks on all participants who were enrolled (ie the 31 participants in the STAIR-PC group and the 29 participants in the WebSTAIR group).

The number of participants who completed at least 90 minutes of an intervention by 15 weeks

Outcome measures

Outcome measures
Measure	STAIR-PC Group n=31 Participants Participants in the Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) group will complete five (30 minute each) therapist-led sessions in-person or via Telehealth for up to 15 weeks.	WebSTAIR Group n=29 Participants Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks.
Feasibility Based on Retention	24 Participants	12 Participants

PRIMARY outcome

Timeframe: 15 weeks, 9 months

Population: The numbers of participants analyzed for this outcome at 15 weeks and 9 months is provided in the the data table and in the participant flow.

The Client Satisfaction Questionnaire (CSQ-8) is an 8-item survey to measure and assess consumer satisfaction with health and human services. Response options differ for each item, the scale ranges from very negative response (1) to a very positive response (4), and the total range for the CSQ-8 can be from 1 to 32 with higher scores indicating higher satisfaction.

Outcome measures

Outcome measures
Measure	STAIR-PC Group n=31 Participants Participants in the Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) group will complete five (30 minute each) therapist-led sessions in-person or via Telehealth for up to 15 weeks.	WebSTAIR Group n=29 Participants Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks.
Acceptability Measured by Client Satisfaction Questionnaire (CSQ-8) 15 weeks	26.6 score on a scale Standard Deviation 3.5	23.7 score on a scale Standard Deviation 6.3
Acceptability Measured by Client Satisfaction Questionnaire (CSQ-8) 9 months	26.1 score on a scale Standard Deviation 4.0	23.3 score on a scale Standard Deviation 5.9

SECONDARY outcome

Timeframe: Baseline, 15 weeks, 9 months

Population: Refer to participant flow for numbers of participants analyzed at baseline, 15 weeks, and 9 months assessments.

The Brief Symptom Inventory (BSI-18) is an 18-item self-report measure to assess psychological problems. The responses for each item ranges from Not At All (0) to Extremely (4), so the toal scores can range from 0 to 72. Higher total scores indicate higher severity of psychological distress.

Outcome measures

Outcome measures
Measure	STAIR-PC Group n=31 Participants Participants in the Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) group will complete five (30 minute each) therapist-led sessions in-person or via Telehealth for up to 15 weeks.	WebSTAIR Group n=29 Participants Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks.
General Mental Health Functioning Measured by the Brief Symptom Inventory (BSI-18) Baseline	37.77 score on a scale Standard Deviation 16.40	37.21 score on a scale Standard Deviation 15.00
General Mental Health Functioning Measured by the Brief Symptom Inventory (BSI-18) 15 weeks	25.80 score on a scale Standard Deviation 16.65	28.30 score on a scale Standard Deviation 14.29
General Mental Health Functioning Measured by the Brief Symptom Inventory (BSI-18) 9 months	20.13 score on a scale Standard Deviation 17.57	25.29 score on a scale Standard Deviation 15.76

SECONDARY outcome

Timeframe: Baseline, 15 weeks, 9 months

Population: Refer to participant flow for numbers of participants analyzed at baseline, 15 weeks, and 9 months assessments.

The Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-report measure of emotion regulation difficulties. Individual item responses range from Almost never (1) to Almost always (5), creating a potential total score range for the DERS of 36 to 180. Higher total scores indicate higher symptom severity.

Outcome measures

Outcome measures
Measure	STAIR-PC Group n=31 Participants Participants in the Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) group will complete five (30 minute each) therapist-led sessions in-person or via Telehealth for up to 15 weeks.	WebSTAIR Group n=29 Participants Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks.
Emotional Regulation Measured by the Difficulties in Emotion Regulation Scale (DERS) Baseline	106.26 score on a scale Standard Deviation 23.47	109.83 score on a scale Standard Deviation 28.28
Emotional Regulation Measured by the Difficulties in Emotion Regulation Scale (DERS) 15 weeks	92.56 score on a scale Standard Deviation 28.52	97.80 score on a scale Standard Deviation 28.58
Emotional Regulation Measured by the Difficulties in Emotion Regulation Scale (DERS) 9 months	80.87 score on a scale Standard Deviation 32.80	87.35 score on a scale Standard Deviation 22.77

SECONDARY outcome

Timeframe: Baseline, 15 weeks, 9 months

Population: Refer to participant flow for numbers of participants analyzed at baseline, 15 weeks, and 9 months assessments.

The TSDS assesses discriminatory distress and anxiety-related trauma symptoms. It includes 21 items, each of which is rated on a 4-point scale ranging from 1 (Never) to 4 (Often). The total score of the TSDS is calculated by adding up the scores from all items and can range from 21 to 84. HIgher scores are asociated with more trauma.

Outcome measures

Outcome measures
Measure	STAIR-PC Group n=31 Participants Participants in the Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) group will complete five (30 minute each) therapist-led sessions in-person or via Telehealth for up to 15 weeks.	WebSTAIR Group n=29 Participants Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks.
Trauma Symptoms as Assessed by the Trauma Symptoms of Discrimination Scale (TSDS) of Discrimination Scale, Baseline	58.39 score on a scale Standard Deviation 16.61	56.34 score on a scale Standard Deviation 16.07
Trauma Symptoms as Assessed by the Trauma Symptoms of Discrimination Scale (TSDS) of Discrimination Scale, 9months	49.83 score on a scale Standard Deviation 18.48	55.38 score on a scale Standard Deviation 19.17
Trauma Symptoms as Assessed by the Trauma Symptoms of Discrimination Scale (TSDS) of Discrimination Scale, 15 weeks	53.08 score on a scale Standard Deviation 16.99	48.30 score on a scale Standard Deviation 16.57

SECONDARY outcome

Timeframe: Baseline, 15 weeks, 9 months

Population: Refer to participant flow for numbers of participants analyzed at baseline, 15 weeks, and 9 months assessments.

The Interpersonal Support Evaluation List - 12-item version (ISEL-12) is a 12-item self-report measure to assess perceptions of social supports. Each item response ranges from Definitely false (1) to Definitely true (4), creating a total score range of 12 to 48. Higher total scores indicate greater social supports.

Outcome measures

Outcome measures
Measure	STAIR-PC Group n=31 Participants Participants in the Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) group will complete five (30 minute each) therapist-led sessions in-person or via Telehealth for up to 15 weeks.	WebSTAIR Group n=29 Participants Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks.
Social Functioning Measured by the Interpersonal Support Evaluation List - 12-item Version (ISEL-12) Baseline	30.48 score on a scale Standard Deviation 7.54	31.26 score on a scale Standard Deviation 7.71
Social Functioning Measured by the Interpersonal Support Evaluation List - 12-item Version (ISEL-12) 15 weeks	32.36 score on a scale Standard Deviation 9.00	31.77 score on a scale Standard Deviation 7.74
Social Functioning Measured by the Interpersonal Support Evaluation List - 12-item Version (ISEL-12) 9 months	34.14 score on a scale Standard Deviation 6.81	33.50 score on a scale Standard Deviation 9.55

Adverse Events

STAIR-PC Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

WebSTAIR Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sarah Valentine, PhD

Boston Medical Center, Psychiatry Department

Phone: (617) 414-1989

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place