NCT06552325

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

August 14, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

August 10, 2024

Last Update Submit

August 10, 2024

Conditions

Keywords

HouselessnessBrief narrative therapyImplementation outcomeIntegrated careReach

Outcome Measures

Primary Outcomes (1)

  • Reach

    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

Study Arms (1)

Single Session Narrative Therapy Intervention

EXPERIMENTAL

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

Interventions

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.

Also known as: Brief Narrative Therapy
Single Session Narrative Therapy Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeSubstance-Related Disorders

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesChemically-Induced DisordersMental Disorders

Study Officials

  • Lydia Chwastiak

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lydia Chwastiak

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

August 10, 2024

First Posted

August 14, 2024

Study Start

September 1, 2024

Primary Completion

January 31, 2025

Study Completion

February 28, 2025

Last Updated

August 14, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

Research subject's de-identified data will be shared through the National Institute of Mental Health Data Archive (NDA).

Time Frame
Data will made available in alignment with the first data submission date required by the National Institute of Mental Health Data Archive.
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.