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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH117221-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STAIR-PC Group | Active Comparator | 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. |
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| WebSTAIR Group | Experimental | Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STAIR-PC Group | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 15 weeks, and 9 months |
| Feasibility Based on Retention | The number of participants who completed at least 90 minutes of an intervention by 15 weeks | 15 weeks |
| 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. | 15 weeks, 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| General Mental Health Functioning Measured by the Brief Symptom Inventory (BSI-18) | 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. | Baseline, 15 weeks, 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Valentine, PhD | Boston Medical Center, Psychiatry Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center Clinics | Boston | Massachusetts | 02118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37244367 | Background | Godfrey LB, Cloitre M, Elwy AR, Fortuna LR, Fuchs C, Valentine SE. Study protocol for a hybrid 1 effectiveness-implementation trial of Brief Skills Training in Affective and Interpersonal Regulation (Brief STAIR) and web-administered STAIR (webSTAIR) for posttraumatic stress disorder in integrated primary care. Contemp Clin Trials. 2023 Aug;131:107241. doi: 10.1016/j.cct.2023.107241. Epub 2023 May 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | WebSTAIR Group | Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| 15 Weeks Assessment |
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| 9 Months Assessment |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | WebSTAIR Group |
| Units | Counts |
|---|---|
| Participants |
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| 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 | 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. | Refer to participant flow for numbers of participants analyzed at baseline, 15 weeks, and 9 months assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 15 weeks, and 9 months |
|
9 months
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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 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Valentine, PhD | Boston Medical Center, Psychiatry Department | (617) 414-1989 | sarah.valentine@bmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 8, 2023 | Jan 24, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 18, 2021 | Feb 28, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| WebSTAIR Group | Behavioral | 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. |
|
| Emotional Regulation Measured by the Difficulties in Emotion Regulation Scale (DERS) | 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. | Baseline, 15 weeks, 9 months |
| Trauma Symptoms as Assessed by the Trauma Symptoms of Discrimination Scale (TSDS) of Discrimination Scale, | 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. | Baseline, 15 weeks, 9 months |
| Social Functioning Measured by the Interpersonal Support Evaluation List - 12-item Version (ISEL-12) | 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. | Baseline, 15 weeks, 9 months |
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Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 |
| WebSTAIR Group |
Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks. |
|
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| Primary | Feasibility Based on Retention | The number of participants who completed at least 90 minutes of an intervention by 15 weeks | 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). | Posted | Count of Participants | Participants | 15 weeks |
|
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 15 weeks, 9 months |
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| Secondary | General Mental Health Functioning Measured by the Brief Symptom Inventory (BSI-18) | 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. | Refer to participant flow for numbers of participants analyzed at baseline, 15 weeks, and 9 months assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 15 weeks, 9 months |
|
|
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| Secondary | Emotional Regulation Measured by the Difficulties in Emotion Regulation Scale (DERS) | 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. | Refer to participant flow for numbers of participants analyzed at baseline, 15 weeks, and 9 months assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 15 weeks, 9 months |
|
|
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| Secondary | Trauma Symptoms as Assessed by the Trauma Symptoms of Discrimination Scale (TSDS) of Discrimination Scale, | 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. | Refer to participant flow for numbers of participants analyzed at baseline, 15 weeks, and 9 months assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 15 weeks, 9 months |
|
|
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| Secondary | Social Functioning Measured by the Interpersonal Support Evaluation List - 12-item Version (ISEL-12) | 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. | Refer to participant flow for numbers of participants analyzed at baseline, 15 weeks, and 9 months assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 15 weeks, 9 months |
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| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | WebSTAIR Group | Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks. | 0 | 29 | 0 | 29 | 0 | 29 |
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| 9 months |
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| 15 weeks |
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| 9 months |
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| 15 weeks |
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| 9 months |
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| 15 weeks |
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| 9months |
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| 15 weeks |
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| 9 months |
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