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NCT Number: NCT06479980

Single Session Narrative Therapy Study

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.

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Key information

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

Location status: Recruiting

Location contact

Akansha Vaswani-Bye, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Single Session Narrative Therapy

Behavioral

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

Primary outcomes

  1. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 0, 1 month

    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.

Secondary outcomes

  1. Generalized Anxiety Disorder- 7 (GAD-7)

    Time frame: 0, 1 month

    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.

  2. Remoralization Scale

    Time frame: 0,1 month

    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.

  3. Social Connectedness Scale-Original (SCS-Original)

    Time frame: 0, 1 month

    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.

  4. State-Trait Assessment of Resilience Scale (Trait sub-scale only)

    Time frame: 0, 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. Total sum scores are calculated for the sub-scale and range from 7 to 28 points; higher scores indicate a better outcome.

  5. Brief Services Evaluation

    Time frame: 0, 1 month

    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.

  6. Acceptability of Intervention Measure (AIM)

    Time frame: 1 month, Up to 8 months

    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.

  7. Intervention Appropriateness Measure (IAM)

    Time frame: Up to 8 months

    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.

  8. Feasibility of Intervention Measure (FIM)

    Time frame: Up to 8 months

    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.

Other outcomes

  1. Waitlist Evaluation Questionnaire

    Time frame: 0 months

    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).

  2. Modified Single Session Impressions and Feedback Tool- Adapted Version

    Time frame: 0 months

    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.

  3. Single Session Consultation Feedback Form

    Time frame: 0 months

    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.

  4. Patient Participant Qualitative Interview

    Time frame: 1 month

    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.

  5. Provider Participant Qualitative Interview

    Time frame: Up to 8 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Akansha Vaswani-Bye, PhD

CONTACT

[email protected]

206-744-9346

Danielle C Chang, BA

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 28, 2024
Registry last updated
Apr 8, 2025

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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