Single Session Narrative Therapy Study

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: Recruiting
• Conditions: HIV; Substance Use; Mental Health Issue
• Intervention / Treatment: Behavioral: Single Session Narrative Therapy

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 (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Akansha Vaswani-Bye, PhD; Phone Number: 206-744-9346; Email: avb9@uw.edu
• Study Contact Backup: Name: Danielle C Chang, BA; Email: danc611@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Recruiting
      • Harborview Medical Center
      • Contact: Akansha Vaswani-Bye, PhD

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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.

Behavioral: Single Session Narrative Therapy; 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: Brief Narrative Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-9 (PHQ-9)	The Patient Health Questionnaire-9 (PHQ-9) is a 9 item 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. A lower PHQ-9 total score indicates a better outcome.	0, 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Generalized Anxiety Disorder- 7 (GAD-7)	The Generalized Anxiety Disorder 7-item (GAD-7) is a 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 lower scores indicating better outcomes.	0, 1 month
Remoralization Scale	The Remoralization Scale is a brief 12-item self-report tool that measures the level of morale. Score is a calculated mean that ranges from 1-4. Higher mean scores indicate a better outcome.	0,1 month
Social Connectedness Scale-Original (SCS-Original)	The Social Connectedness Scale is an 8-item instrument which assesses the degree to which one feels connected to others in their social environment. Items are measured on a 6-point Likert scale (Strongly Agree-Strongly Disagree). Total scores range from 8 to 48 points. Higher total scores indicate a better outcome.	0, 1 month
State-Trait Assessment of Resilience Scale (Trait sub-scale only)	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. Total sum scores are calculated for the sub-scale and range from 7 to 28 points; higher scores indicate a better outcome.	0, 1 month
Brief Services Evaluation	The Brief Services Evaluation is a 6-item instrument which measures patients' assessment of their skills, ideas, and knowledge regarding the main problem/issue that brought them into counseling. Items are measured on a 6-point Likert scale (Strongly Disagree- Strongly Agree). Score is a calculated mean that ranges from 1-6. Higher mean scores indicate a better outcome.	0, 1 month
Acceptability of Intervention Measure (AIM)	The Acceptability of Intervention Measure is a 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is a calculated mean that ranges from 1-5. Higher mean scores indicate a better outcome.	1 month, Up to 8 months
Intervention Appropriateness Measure (IAM)	The Intervention Appropriateness Measure is a 4-item measure of perceived intervention appropriateness. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is a calculated mean that ranges from 1-5. Higher mean scores indicate a better outcome.	Up to 8 months
Feasibility of Intervention Measure (FIM)	The Feasibility of Intervention Measure is a 4-item instrument to assess perceived intervention feasibility. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is a calculated mean that ranges from 1-5. Higher mean scores indicate a better outcome.	Up to 8 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waitlist Evaluation Questionnaire	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).	0 months
Modified Single Session Impressions and Feedback Tool- Adapted Version	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 (Strongly Disagree-Strongly Agree), where 7 represents the most positive score.	0 months
Single Session Consultation Feedback Form	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"), where 5 represents the most positive score.	0 months
Patient Participant Qualitative Interview	Qualitative interviews will be conducted with a subset of patient participants approximately 1 month after receiving the single session narrative therapy intervention. Interviews will be 30-45 minutes and address acceptability and appropriateness of the intervention; experiences being offered and participating in the intervention; facilitators and barriers to participating; what was particularly meaningful or useful about the intervention, and suggestions for improving the intervention.	1 month
Provider Participant Qualitative Interview	Qualitative interviews will be conducted with a purposive sample of providers whose patients received the single session intervention to assess intervention acceptability, feasibility, and fit.	Up to 8 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Akansha Vaswani-Bye, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): December 31, 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): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Psychotherapy; Stepped care; Brief narrative therapy; Implementation outcome; Integrated primary care
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• 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