Single Session Narrative Therapy Study
NCT Number: NCT06479980
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mental Health Issue|HIV|Substance Use
Interventions: BEHAVIORAL: Single Session Narrative Therapy
Sponsor: University of Washington
Collaborators: National Institute of Mental Health (NIMH)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-04
Completion Date: 2025-01-04
Locations: Harborview Medical Center, Seattle, Washington, 98104, United States

Summary:
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.

Primary Outcome Measures: 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: 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: 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