- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06552325
Walk-in Therapy in Low Barrier Primary Care
August 10, 2024 updated by: Lydia Chwastiak, University of Washington
Integrating Brief Narrative Therapy in Low Barrier Clinics to Enhance HIV Prevention
The goals of the current research are to adapt an effective walk-in psychotherapy clinic intervention for the context of low-barrier primary care; and conduct a pilot implementation study in two low-barrier primary care clinics that are based in a community organization that is a drop-in center for people experiencing homelessness in North Seattle.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Interactions between the multiple health threats of mental illness, substance use, and social vulnerabilities (homelessness, poverty) represent a syndemic that perpetuates the HIV epidemic.
Mental health and substance use disorders have been shown to increase HIV risk behaviors and to have a negative impact on adherence to PrEP.
Unhoused individuals face both individual-level (stigma, limited social support, and psychiatric symptoms) and structural-level (poverty, unstable housing, limited transportation, cost of medical care) barriers to healthcare.
Walk-in clinics are designed to address these barriers to traditional primary care and provide immediate access to services when they are needed.
King County WA has funded four low-barrier primary care clinics since 2018 as a key component of the King County EHE Plan.
Data from these clinics suggest that untreated mental disorders are a critical barrier to engagement in low-barrier primary care.
Integrated care models in which trained mental health specialists deliver evidence-based mental health care in primary care settings increase access to care by providing mental health treatment where people are already seeking care.
Integrated care improves mental health outcomes, and models are feasible to implement even in very low resource settings.
Walk-in counseling clinics throughout the province of Ontario, Canada, have implemented a single session narrative therapy intervention to increase access to mental health care.
In this model, therapists use a single-session approach to help clients identify issues, recognize and build on their strengths and develop an action plan.
Narrative approaches create a non-pathologizing, collaborative, and competency-oriented way of addressing mental health needs.
Given the unpredictability of follow-up in walk-in primary care, a single session narrative approach can make the most of every single session, providing pragmatic therapeutic conversations to people when they need it and support coping, reduce feelings of isolation, and increase sense of validation.
The goals of the current study are 1) to develop a single-session narrative therapy intervention to increase access to mental health care among people experiencing homelessness; and 2) conduct a 4-month pilot implementation trial of the adapted intervention in two low-barrier primary care clinics in North Seattle.
Study Type
Interventional
Enrollment (Estimated)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lydia Chwastiak
- Phone Number: 206-744-4840
- Email: lchwast@uw.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Patient Inclusion Criteria:
- Will have completed at least one therapy appointment at the [Blinded] clinics
- Ability to provide informed consent
- Ability to complete the interview or questionnaire in English
Patient Exclusion Criteria:
- Inability to provide informed consent
- Need for urgent mental health treatment (e.g., imminent risk of harm to self or others, acute withdrawal requiring medical detoxification)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single Session Narrative Therapy Intervention
A single narrative therapy session with a trained licensed behavioral health provider will be offered to patients at [Blinded] low-barrier clinics.
|
The proposed single session narrative therapy intervention has been widely implemented in walk-in therapy clinics in Ontario Province, Canada.
In these clinics, 60-minute psychotherapy sessions, informed by narrative therapy, are available on a walk-in basis.
The therapist collaborates with a patient to co-develop a useful and meaningful focus for the session and then engages the patient in conversation that is respectful but shifts their way of thinking about the presenting problem.
The therapist highlights and documents the patient's values and skills and works with the patient to create an action plan.
If the therapist identifies additional treatment needs, the patient is offered an external referral to specialty mental health services.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reach
Time Frame: Up to 4 months
|
Number and representativeness of patients (with respect to gender, race/ethnicity, current substance use) who have ≥1 session with the therapist (compared to full clinic populations).
|
Up to 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lydia Chwastiak, University of Washington
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2024
Primary Completion (Estimated)
January 31, 2025
Study Completion (Estimated)
February 28, 2025
Study Registration Dates
First Submitted
August 10, 2024
First Submitted That Met QC Criteria
August 10, 2024
First Posted (Actual)
August 14, 2024
Study Record Updates
Last Update Posted (Actual)
August 14, 2024
Last Update Submitted That Met QC Criteria
August 10, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00018557
- 3P30MH123248-03 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Research subject's de-identified data will be shared through the National Institute of Mental Health Data Archive (NDA).
IPD Sharing Time Frame
Data will made available in alignment with the first data submission date required by the National Institute of Mental Health Data Archive.
IPD Sharing Access Criteria
Summary information on the data shared in NDA is available in the NDA Query Tool without the need for an NDA user account.
To request access to record-level human subject data, a Data Access Request must be submitted.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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