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Mental Health IssueNCT06552325

Walk-in Therapy in Low Barrier Primary Care

A study testing Single Session Narrative Therapy in people with Mental Health Issue and Hiv, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Mental Health Issue, Hiv, Substance Use
What is being tested?
Single Session Narrative Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteUnited States
Study dates
3 Oct 2024to 10 Apr 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Harborview Medical Center

    Seattle, Washington, 98104

Other trials in United States

About this study

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

Read the 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 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.

Being tested
Single Session Narrative Therapy
Keywords
Houselessness, Brief narrative therapy, Implementation outcome, Integrated care, Reach
Medical subject headings
Acquired Immunodeficiency Syndrome, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single Session Narrative TherapyBehavioural

    Also called Brief 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.

Study groups in NCT06552325
Study groupRoleWhat they receive
Single Session Narrative Therapy InterventionExperimentalA single narrative therapy session with a trained licensed behavioral health provider will be offered to patients at [Blinded] low-barrier clinics.
Receives: Behavioral: Single Session Narrative Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number and Representativeness of Participants (Reach)

    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).

    Measured: at enrollment

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

    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.

    Measured: 1 month

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

    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.

    Measured: 1 month

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

    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.

    Measured: 1 month

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

    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.

    Measured: 1 month

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

    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.

    Measured: 1 month

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

    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.

    Measured: 1 month

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

    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.

    Measured: 1 month

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

    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.

    Measured: 1 month

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

    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.

    Measured: 1 month

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

    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.

    Measured: 1 month

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

    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.

    Measured: 1 month

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

    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.

    Measured: 1 month

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

    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.

    Measured: 1 month

  15. Service Utilization (Implementation)

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

    Measured: 1 month

  16. Fidelity to SSNT (Implementation)

    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.

    Measured: during SSNT session

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

    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.

    Measured: immediately post-session

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

    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.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2024
  2. Study start3 Oct 2024
  3. Primary completion10 Apr 2025
  4. Study completion10 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06552325
Sponsor's protocol ID
STUDY00018557
Other IDs
3P30MH123248-03
Status last verified
Jul 2026
First submitted
10 Aug 2024
Last updated
9 Sep 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: A de-identified dataset of the research survey data will be provided to investigators upon request.

Questions about this trial

What is this clinical trial studying?

A study testing Single Session Narrative Therapy in people with Mental Health Issue and Hiv, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and Representativeness of Participants (Reach) (time frame: at enrollment). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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