- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06479980
Single Session Narrative Therapy Study
September 3, 2026 updated by: Akansha Vaswani Bye, University of Washington
Pilot Study of Feasibility, Acceptability, Fit and Clinical Impact of a Single Session Narrative Psychotherapy Intervention to Reduce Wait Times in a Primary Care HIV Clinic
This pilot research study will provide timely access to behavioral health services through the provision of a single-session narrative therapy intervention.
The goal of this 6-month study is to test the acceptability, feasibility, and fit of the intervention in an integrated primary care clinic serving people living with HIV.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Single-session interventions are designed to address barriers to engaging in care and address the issues of long waitlists and limited provider availability.
Offering a single session intervention soon after a referral is made is a strategy on a stepped-care continuum model that has been found to be an effective approach to manage population mental health needs.
This study aims to 1) pre-pilot a single-session narrative therapy intervention with patients currently on the waitlist for psychotherapy services at an HIV primary care clinic to evaluate the acceptability of this treatment option for patients and the feasibility of proposed data collection followed by 2) a 6-month pilot study of the same intervention to evaluate intervention acceptability, fit, and impact on service and clinical outcomes.
At the end of this study, patient and provider-level data on the utility of integrating a single-session psychotherapy service as part of the continuum of behavioral health services in an integrated care setting will be obtained, which the investigators can utilize to design a larger implementation-effectiveness trial.
Study Type
Interventional
Enrollment (Actual)
64
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 Locations
-
-
Washington
-
Seattle, Washington, United States, 98104
- Harborview Medical Center
-
-
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
- Adults (age 18 years and older) who are patients at [Blinded] Clinic
- Have agreed to participate in the single session intervention
- Ability to complete the interview and research surveys in English
Patient Exclusion Criteria:
- Participants with need for urgent mental health treatment (e.g., at imminent risk of suicide or harm to others; disabling symptom presentation)
- Inability to provide informed consent
Provider Inclusion Criteria:
- Adults (age 18 years and older)
- Referring providers at [Blinded] clinic (social worker, primary care physician, mental health professional etc.)
- Ability to complete the research survey or interview in English.
Provider Exclusion Criteria:
- Inability to provide informed consent
- Non-referring providers
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 60-75 minute narrative therapy session with a trained licensed behavioral health provider will be offered to patients on the psychotherapy waitlist of an HIV primary care clinic.
|
Single-session narrative psychotherapy intervention is an evidence-based strategy on a stepped care continuum that can assist patients in accessing care when they most need it and can lead to the most effective utilization of scarce resources.
It offers a transdiagnostic, strengths, solution-oriented, and non-pathologizing intervention to address patients' behavioral health needs.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 1 month
|
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item validated self-report measure used to screen for depression, diagnose it, monitor its severity, and measure treatment response.
The PHQ-9 ranges from 0 to 27 points, with higher scores reflecting more severe symptoms.
Scores ≥ 10 indicate moderate depression.
This measure was only collected and reported for patient participants.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Generalized Anxiety Disorder- 7 (GAD-7)
Time Frame: 1 month
|
The Generalized Anxiety Disorder 7-item (GAD-7) is a validated brief self-report tool that measures anxiety symptoms based on the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria.
The total score ranges from 0 to 21, with higher scores indicating greater severity.
Scores ≥ 10 indicate moderate anxiety.
This measure was only collected and reported for patient participants.
|
1 month
|
|
Remoralization Scale
Time Frame: 1 month
|
The Remoralization Scale is a validated 12-item self-report measure rated on a 4-point scale ranging from 1 ("Totally disagree") to 4 ("Totally agree") that assesses the level of remoralization.
The total score ranges from 12 to 48, with higher scores indicating higher levels of remoralization.
This measure was only collected and reported for patient participants.
|
1 month
|
|
Social Connectedness Scale-Original (SCS-Original)
Time Frame: 1 month
|
The Social Connectedness Scale is an 8-item instrument that assesses the degree to which one feels connected to others in their social environment.
Items are measured on a 6-point Likert scale ranging from 1 ("Strongly Agree") to 6 ("Strongly Disagree").
Total scores range from 8 to 48 points.
Higher total scores indicate a greater sense of social connectedness.
This measure was only collected and reported for patient participants.
|
1 month
|
|
State-Trait Assessment of Resilience Scale (Trait Sub-scale Only)
Time Frame: 1 month
|
The State-Trait Assessment of Resilience Scale measures resilience using a state and trait approach, based on the conceptualization of resilience as being influenced by a combination of state and trait factors.
This study will only measure the 'Trait' level of resilience, using the trait sub-scale (7-item instrument), which is construed as more distal and enduring.
Items are measured on a 4-point Likert scale ranging from 1 ("Disagree") to 4 ("Strongly agree").
Total sum scores are calculated for the sub-scale and range from 7 to 28 points; higher scores reflect greater resilience.
This measure was only collected and reported for patient participants.
|
1 month
|
|
Brief Services Evaluation
Time Frame: 1 month
|
The Brief Services Evaluation is a 6-item self-report measure assessing patients' perceptions of their skills, ideas, and knowledge related to the primary problem that brought them to counseling.
Items are rated on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree").
Item-level score totals range from 1 to 6.
We report item-level changes and significance levels consistent with the Canadian study.
The BSE was completed by pilot participants immediately before and one month after their first SSNT session.
This measure was only collected and reported for patient participants.
|
1 month
|
|
Acceptability of Intervention Measure (AIM)
Time Frame: 1 Month for patient participants; 0 Month for referring providers
|
The Acceptability of Intervention Measure is a 4-item measure of perceived intervention acceptability.
Items are measured on a 5-point Likert scale 1 ("Completely Disagree") to 5 ("Completely Agree").
Score is a calculated mean that ranges from 1-5.
Higher mean scores indicating greater perceived intervention acceptability.
|
1 Month for patient participants; 0 Month for referring providers
|
|
Intervention Appropriateness Measure (IAM)
Time Frame: 0 Month for referring providers
|
The Intervention Appropriateness Measure is a 4-item measure of perceived intervention appropriateness.
Items are measured on a 5-point Likert scale 1 ("Completely Disagree") to 5 ("Completely Agree").
Score is a calculated mean that ranges from 1-5.
Higher mean scores indicating greater perceived intervention acceptability.
|
0 Month for referring providers
|
|
Feasibility of Intervention Measure (FIM)
Time Frame: 0 Month for referring providers
|
The Feasibility of Intervention Measure is a 4-item measure of perceived intervention feasibility.
Items are measured on a 5-point Likert scale 1 ("Completely Disagree") to 5 ("Completely Agree").
Score is a calculated mean that ranges from 1-5.
Higher mean scores indicating greater perceived intervention feasibility.
|
0 Month for referring providers
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Waitlist Evaluation Questionnaire
Time Frame: 0 Month
|
A 2-item questionnaire evaluating: a) if a patient would like to remain or be taken off the psychotherapy waitlist of [Blinded] clinic (yes or no) b) if the patient selects to remain on the waitlist, what service type they are seeking (Up to 3 single sessions scheduled when needed or 12-16 regularly scheduled sessions).
This measure was only collected and reported for patient participants.
|
0 Month
|
|
Modified Single Session Impressions and Feedback Tool- Adapted Version
Time Frame: 0 month
|
The Single Session Impressions and Feedback tool is an 8-item post-session questionnaire which measures patient satisfaction and the degree to which the therapist adhered to key single session narrative therapy principles during the session.
Items are measured a 7-point Likert scale from "1" (Strongly Disagree) to "7" (Strongly Agree) with the exception of the final item which is open-entry.
Item level scores are reported.
Item scores range from 1 to 7. Higher scores indicate greater patient satisfaction and therapist adherence to the intervention.
As the SSIFT was designed as a therapist feedback tool, its psychometric properties have not been reported.
The measure was only collected and reported for patient participants immediately after their first SSNT encounter.
|
0 month
|
|
Single Session Consultation Feedback Form
Time Frame: 0 month
|
The Single Session Consultation Feedback Form is a 5-item post-session questionnaire that measures patients' satisfaction with the therapy intervention.
Items are measured on a Likert scale from 1 ("Not at all") to 5 ("Very much") with the exception of the final item which is open-entry.
A higher score indicates greater satisfaction with the intervention.
This measure was only collected and reported for patient participants.
|
0 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Akansha Vaswani-Bye, 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 (Actual)
June 4, 2024
Primary Completion (Actual)
May 15, 2025
Study Completion (Actual)
May 15, 2025
Study Registration Dates
First Submitted
June 15, 2024
First Submitted That Met QC Criteria
June 23, 2024
First Posted (Actual)
June 28, 2024
Study Record Updates
Last Update Posted (Actual)
September 8, 2026
Last Update Submitted That Met QC Criteria
September 3, 2026
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00018612
- 5P30MH123248-03 (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
product manufactured in and exported from the U.S.
No
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