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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Single Session Narrative Therapy
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:
  • Brief Narrative Therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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