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Completed

NCT Number: NCT06552325

Walk-in Therapy in Low Barrier Primary Care

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 a low-barrier primary care clinic based in a community organization that is a drop-in center for people experiencing homelessness in North Seattle.

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Key information

Conditions

Mental Health Issue Acquired Immunodeficiency Syndrome Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases HIV HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Substance Use Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harborview Medical Center

Seattle, Washington, 98104, United States

About this study

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 pre-exposure prophylaxis (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, Washington has funded four low-barrier primary care clinics since 2018 as a key component of the King County Ending the HIV Epidemic (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 an 8-month pilot implementation trial of the adapted intervention in a low-barrier primary care clinic in North Seattle. We will conduct a mixed methods evaluation of the Reach, Effectiveness, and Implementation of the single-session narrative therapy (SSNT) intervention, guided by the Reach Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Single Session Narrative Therapy

Behavioral

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

Primary outcomes

  1. Number and Representativeness of Participants (Reach)

    Time frame: at enrollment

    Number of patients who participated in research and had ≥1 session with the therapist; Representativeness of patients (with respect to age, gender, race/ethnicity, living situation, employment, insurance, education) who had ≥1 session with the therapist (compared to full clinic population).

  2. Number of Participants That Completed Interviews by Interview Type (Reach, Effectiveness and Implementation)

    Time frame: 1 month

    Staff, therapist and pilot participant in-depth interviews were conducted post-implementation by research team members. They explored stakeholder perspectives on who was not reached, why they were not reached and opportunities for improvement (Reach); SSNT impact on clients (Effectiveness); acceptability and appropriateness of the intervention, and determinants of implementation (Implementation). After interviews were collected, we used rapid deductive qualitative analysis to assess these outcomes, and generated a table with key findings.

  3. Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score (Effectiveness)

    Time frame: 1 month

    The PHQ-8 is a validated measure of depression symptom severity over the previous two weeks. The total score ranges from 0-24 with higher scores reflecting more severe symptoms; a cut-off score of 10 has high sensitivity and specificity for clinically significant depressive symptoms. It was completed by pilot participants immediately before and approximately one month after their first SSNT session.

  4. Anxiety Symptoms Measured by Generalized Anxiety Disorder 7-item (GAD-7) Score (Effectiveness)

    Time frame: 1 month

    The GAD-7 is a validated measure of anxiety symptom severity over the previous two weeks. The total score ranges from 0-21 with higher score reflecting more severe symptoms; a cut-off score of 10 has good sensitivity and specificity for a diagnosis of generalized anxiety disorder. It was completed by pilot participants immediately before and approximately one month after their first SSNT session.

  5. Psychological Well-being Measured by World Health Organization-Five Well-Being Index (WHO-5) Score (Effectiveness)

    Time frame: 1 month

    The WHO-5 is a validated measure of psychological well-being that asks how often someone felt cheerful, calm, active, fresh, and interested in life over the last two weeks. Total score range is 0-25, with a higher score indicating greater well-being. A score below 13 suggests the need to screen for depression. It was completed by pilot participants immediately before and approximately one month after their first SSNT session.

  6. Individual's Resilience Measured by Trait Resilience From the State-Trait Assessment of Resilience Scale (STARS) (Effectiveness)

    Time frame: 1 month

    Trait Resilience from STARS assesses an individual's resilience within a variety of demanding contexts. The 7-item questionnaire has a 4-point Likert scale response range of "Disagree" to "Strongly Agree;" total score ranges from 7-28, with higher scores reflecting greater resilience. It was completed by pilot participants immediately before and approximately one month after their first SSNT session.

  7. Social Connectedness Measured by The Social Connectedness Scale (Effectiveness)

    Time frame: 1 month

    The Social Connectedness Scale is a reliable and valid 6-item self-report measure based on Kohut's self-psychology theory. Total scores range from 6-36, with higher scores reflecting a greater sense of social connectedness. Validation studies have shown good internal reliability and test stability over two-week period. It was completed by pilot participants immediately before and approximately one month after their first SSNT session.

  8. General Health Measured by General Health Domain From the 36-Item Medical Outcomes Study Short Form Survey (SF-36) (Effectiveness)

    Time frame: 1 month

    The single-item General Health domain from the 36-Item Medical Outcomes Study Short Form Survey (SF-36) asks "In general, would you say your health is:" and has a five-point Likert scale response range from Excellent (1) to Poor (5). This single item has been validated as an indicator of health perception, differentiating between healthy and ill groups, and is reliable and valid across diverse populations, including people experiencing homelessness. It was completed by pilot participants immediately before and approximately one month after their first SSNT session.

  9. Understanding of Problem Item From Brief Services Evaluation (Effectiveness)

    Time frame: 1 month

    The Brief Services Evaluation (BSE) was developed as part of the evaluation plan for an SSNT multisite program in Canada. Outcomes include understanding of problem, awareness of one's own strengths and skills, ideas to address problem, and awareness of community resources and social support. Each item is scored on a 6-point Likert scale from 1 to 6, with higher scores representing better outcomes. We report item-level changes and significance levels, as done in the Canadian study. The BSE was completed by pilot participants immediately before and one month after their first SSNT session.

  10. Possession of Skills Needed to Solve Problem Item From Brief Services Evaluation (Effectiveness)

    Time frame: 1 month

    The Brief Services Evaluation (BSE) was developed as part of the evaluation plan for an SSNT multisite program in Canada. Outcomes include understanding of problem, awareness of one's own strengths and skills, ideas to address problem, and awareness of community resources and social support. Each item is scored on a 6-point Likert scale from 1 to 6, with higher scores representing better outcomes. We report item-level changes and significance levels, as done in the Canadian study. The BSE was completed by pilot participants immediately before and one month after their first SSNT session.

  11. Awareness of Strengths Item From Brief Services Evaluation (Effectiveness)

    Time frame: 1 month

    The Brief Services Evaluation (BSE) was developed as part of the evaluation plan for an SSNT multisite program in Canada. Outcomes include understanding of problem, awareness of one's own strengths and skills, ideas to address problem, and awareness of community resources and social support. Each item is scored on a 6-point Likert scale from 1 to 6, with higher scores representing better outcomes. We report item-level changes and significance levels, as done in the Canadian study. The BSE was completed by pilot participants immediately before and one month after their first SSNT session.

  12. Ideas About How to Solve Problem Item From Brief Services Evaluation (Effectiveness)

    Time frame: 1 month

    The Brief Services Evaluation (BSE) was developed as part of the evaluation plan for an SSNT multisite program in Canada. Outcomes include understanding of problem, awareness of one's own strengths and skills, ideas to address problem, and awareness of community resources and social support. Each item is scored on a 6-point Likert scale from 1 to 6, with higher scores representing better outcomes. We report item-level changes and significance levels, as done in the Canadian study. The BSE was completed by pilot participants immediately before and one month after their first SSNT session.

  13. Knowledge About Social Supports to Help Item From Brief Services Evaluation (Effectiveness)

    Time frame: 1 month

    The Brief Services Evaluation (BSE) was developed as part of the evaluation plan for an SSNT multisite program in Canada. Outcomes include understanding of problem, awareness of one's own strengths and skills, ideas to address problem, and awareness of community resources and social support. Each item is scored on a 6-point Likert scale from 1 to 6, with higher scores representing better outcomes. We report item-level changes and significance levels, as done in the Canadian study. The BSE was completed by pilot participants immediately before and one month after their first SSNT session.

  14. Knowledge About Community Resources to Help Item From Brief Services Evaluation (Effectiveness)

    Time frame: 1 month

    The Brief Services Evaluation (BSE) was developed as part of the evaluation plan for an SSNT multisite program in Canada. Outcomes include understanding of problem, awareness of one's own strengths and skills, ideas to address problem, and awareness of community resources and social support. Each item is scored on a 6-point Likert scale from 1 to 6, with higher scores representing better outcomes. We report item-level changes and significance levels, as done in the Canadian study. The BSE was completed by pilot participants immediately before and one month after their first SSNT session.

  15. Service Utilization (Implementation)

    Time frame: 1 month

    Service utilization was measured as the number of SSNT sessions received by each neighbor

  16. Fidelity to SSNT (Implementation)

    Time frame: during SSNT session

    Therapists' session notes were analyzed for the presence of two fidelity indicators: whether the note indicated that the session had a beginning, middle, and end, and whether narrative therapy skills were used.

  17. Acceptability Measured by Single Session Impression and Feedback Tool (SSIFT) (Implementation)

    Time frame: immediately post-session

    The Single Session Impression and Feedback Tool (SSIFT) is considered as an indicator of acceptability. Developed for walk-in clinics implementing SSNT, it includes eight items on a 7-point scale (range 1-7) that invite feedback from participants on their perception of the process and outcome of the SSNT intervention. Six items focus on how collaborative the service was, one on the degree of hope the conversation engendered, and one on the conversation's usefulness. We report the mean across the eight items, and higher scores indicate more favorable impressions of the SSNT intervention. As the SSIFT was designed as a therapist feedback tool, its psychometric properties have not been reported. This evaluation was completed by pilot participants immediately after their first SSNT session.

  18. Acceptability Measured by Acceptability of Intervention Measure (AIM) (Implementation)

    Time frame: 1 month

    The Acceptability of Intervention Measure (AIM) is a valid and reliable 4-item patient-reported outcome measure that measures the acceptability of an intervention. Responses to items are a 5-point Likert scale from Completely Disagree (1) to Completely Agree (5). We report the mean across the 4 items, and a higher score indicates greater intervention acceptability (range 1-5). The AIM was completed 1-month after pilot participants' first SSNT session.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Integrating Brief Narrative Therapy in Low Barrier Clinics to Enhance HIV Prevention

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2024
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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