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

Implementing a Skills Training Evidence-Based Treatment for Posttraumatic Stress Disorder in Primary Care (I-STEP)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04937504

Acronym

I-STEP

Enrollment

Registered

2021-06-24

Start date

2021-06-29

Completion date

2024-02-26

Last updated

2025-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder

Keywords

Mental health treatment, Primary Care, STAIR intervention, webSTAIR intervention

Brief summary

A majority of residents in low income communities have been exposed to a potentially traumatic event, and up to half (30-50%) of trauma-exposed residents in safety net clinical settings meet criteria for posttraumatic stress disorder (PTSD). Despite this, only 13% receive treatment. Poor access to PTSD treatment is due to a shortage of mental health specialists. This study aims to evaluate the implementation and effectiveness of a brief, cognitive-behavioral intervention for posttraumatic stress disorder (PTSD)-Skills Training in Affective and Interpersonal Regulation (STAIR)- that will be offered in Boston Medical Center (BMC)'s primary care clinics as the new standard of care following integrated behavioral healthcare (IBH) therapist training. In response to clinician capacity concerns and the impact of the COVID-19 pandemic, we will be offering the intervention in both clinician-administered and self-paced, web-administered formats. The evidence base suggests that STAIR, delivered both synchronously (in-person/telehealth STAIR) and asynchronously (webSTAIR), is associated with significant improvements in PTSD and depression symptoms.

Detailed description

Participants who enroll in the study will be randomized to either in-person/telehealth STAIR or webSTAIR. Those who do not enroll in the study will still be able to receive STAIR in person or via telehealth as part of usual care. Participant data will be for 9 months. Treatment plans will continue to be determined by usual care providers, the study has no involvement in any decisions regarding care. This means that a participant's IBH therapist can continue the therapy, offer a different treatment option, or refer to other services at any time in the study and after the study is completed. At any time, patients can also choose to change their treatment plans, for example from webSTAIR to in-person/telehealth STAIR, or to another treatment option in the clinic. Access to webSTAIR will be discontinued at 9 months. The investigators hypothesize that offering a low intensity treatment for PTSD through primary care will improve access to and engagement in care for PTSD among BMC's patient population. The feasibility of two modes of treatment delivery will be compared, while gathering further evidence of the effectiveness of the intervention in our local setting. It is also hypothesized that both formats will be effective in reducing mental health symptoms, while webSTAIR may have some advantages in regard to uptake and long-term sustainability in usual care.

Interventions

BEHAVIORALSTAIR-PC Group

Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) is a face-to-face, individual, brief (5 session) therapy adapted from the STAIR program. STAIR-PC is an appropriate treatment for individuals who have experienced traumatic stressors, and addresses symptom targets by teaching skills to improve coping with emotions and strengthen interpersonal relationships.

BEHAVIORALWebSTAIR Group

WebSTAIR is a web-based self-help program adapted from the STAIR program for individuals who have experienced traumatic stressors. WebSTAIR contains 10 self-guided interactive modules that teach skills to improve coping with emotions and strengthen interpersonal relationships.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Client seen in integrated behavioral health in Boston Medical Center's General Internal Medicine and Family Medicine clinics. * Able to receive therapy in English (per participant report) * Exposure to trauma (as indicated by Life Events Checklist (LEC) for the Diagnostic and Statistical Manual of Mental Disorders (DSM) DSM-5 \[LEC-5\]) * Subthreshold or Full Criteria for PTSD (as indicated by the PTSD Checklist Posttraumatic Stress Disorder Checklist (PCL) for the DSM-5 \[PCL-5\]) * Reasonable to access to technology needed to support either condition (e.g., phone, computer, internet access).

Exclusion criteria

* Patient is not appropriate for outpatient level of care / standard of care provided in Integrated behavioral health (IBH) per clinician judgement * Currently receiving cognitive behavioral therapy for PTSD elsewhere e.g., cognitive processing theory (CPT), prolonged exposure (PE), eye movement desensitization and reprocessing (EMDR). * Patient is experiencing bereavement (death of someone close) as primary clinical concern, and is therefore not a good fit for a PTSD-specific treatment at this time.

Design outcomes

Primary

Measure	Time frame	Description
Posttraumatic Stress Disorder Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5)	Baseline, 15 weeks, and 9 months	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.
Feasibility Based on Retention	15 weeks	The number of participants who completed at least 90 minutes of an intervention by 15 weeks
Acceptability Measured by Client Satisfaction Questionnaire (CSQ-8)	15 weeks, 9 months	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.

Secondary

Measure	Time frame	Description
General Mental Health Functioning Measured by the Brief Symptom Inventory (BSI-18)	Baseline, 15 weeks, 9 months	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.
Social Functioning Measured by the Interpersonal Support Evaluation List - 12-item Version (ISEL-12)	Baseline, 15 weeks, 9 months	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.
Emotional Regulation Measured by the Difficulties in Emotion Regulation Scale (DERS)	Baseline, 15 weeks, 9 months	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.
Trauma Symptoms as Assessed by the Trauma Symptoms of Discrimination Scale (TSDS) of Discrimination Scale,	Baseline, 15 weeks, 9 months	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	31
WebSTAIR Group Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks.	29
Total	60

Withdrawals & dropouts

Period	Reason	FG000	FG001
15 Weeks Assessment	Lost to Follow-up	5	9
9 Months Assessment	Lost to Follow-up	3	2

Baseline characteristics

Characteristic	STAIR-PC Group	WebSTAIR Group	Total
Age, Continuous	35.69 years STANDARD_DEVIATION 14.95	36.28 years STANDARD_DEVIATION 10.57	35.97 years STANDARD_DEVIATION 12.92
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants	7 Participants	15 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants	22 Participants	45 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Asian	2 Participants	0 Participants	2 Participants
Race (NIH/OMB) Black or African American	18 Participants	19 Participants	37 Participants
Race (NIH/OMB) More than one race	4 Participants	4 Participants	8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants	0 Participants	2 Participants
Race (NIH/OMB) White	5 Participants	5 Participants	10 Participants
Region of Enrollment United States	31 participants	29 participants	60 participants
Sex/Gender, Customized Declined to answer	0 Participants	1 Participants	1 Participants
Sex/Gender, Customized Female	25 Participants	27 Participants	52 Participants
Sex/Gender, Customized Male	4 Participants	0 Participants	4 Participants
Sex/Gender, Customized Queer/Non Binary/Other	2 Participants	1 Participants	3 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 31	0 / 29
other Total, other adverse events	0 / 31	0 / 29
serious Total, serious adverse events	0 / 31	0 / 29

Outcome results

Primary

Acceptability Measured by Client Satisfaction Questionnaire (CSQ-8)

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.

Time frame: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
STAIR-PC Group	Acceptability Measured by Client Satisfaction Questionnaire (CSQ-8)	15 weeks	26.6 score on a scale	Standard Deviation 3.5
STAIR-PC Group	Acceptability Measured by Client Satisfaction Questionnaire (CSQ-8)	9 months	26.1 score on a scale	Standard Deviation 4
WebSTAIR Group	Acceptability Measured by Client Satisfaction Questionnaire (CSQ-8)	15 weeks	23.7 score on a scale	Standard Deviation 6.3
WebSTAIR Group	Acceptability Measured by Client Satisfaction Questionnaire (CSQ-8)	9 months	23.3 score on a scale	Standard Deviation 5.9

Primary

Feasibility Based on Retention

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

Time frame: 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).

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
STAIR-PC Group	Feasibility Based on Retention	24 Participants
WebSTAIR Group	Feasibility Based on Retention	12 Participants

Primary

Posttraumatic Stress Disorder Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5)

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.

Time frame: Baseline, 15 weeks, and 9 months