Mental Health IssueNCT06479980
Single Session Narrative Therapy Study
A study testing Single Session Narrative Therapy in people with Mental Health Issue and HIV, run by University of Washington at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue, HIV, Substance Use
- What is being tested?
- Single Session Narrative Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2024to 15 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official 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
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.
Read the 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.
- Conditions
- Mental Health Issue, HIV, Substance Use
- Being tested
- Single Session Narrative Therapy
- Keywords
- Brief narrative therapy, Implementation outcome, Stepped care, Psychotherapy, Integrated primary care
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Session Narrative TherapyBehavioural
Also called Brief 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.
| Study group | Role | What they receive |
|---|---|---|
| Single Session Narrative Therapy Intervention | Experimental | 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. Receives: Behavioral: Single Session Narrative Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 (PHQ-9)
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.
Measured: 1 month
Secondary outcomes (8)
Generalized Anxiety Disorder- 7 (GAD-7)
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.
Measured: 1 month
Remoralization Scale
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.
Measured: 1 month
Social Connectedness Scale-Original (SCS-Original)
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.
Measured: 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. 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.
Measured: 1 month
Brief Services Evaluation
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.
Measured: 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 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.
Measured: 1 Month for patient participants; 0 Month for referring providers
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 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.
Measured: 0 Month for referring providers
Feasibility of Intervention Measure (FIM)
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.
Measured: 0 Month for referring providers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start4 Jun 2024
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Akansha Vaswani Bye, University of Washington
- Investigators
- Akansha Vaswani-Bye, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479980
- Sponsor's protocol ID
- STUDY00018612
- Other IDs
- 5P30MH123248-03
- Status last verified
- Apr 2025
- First submitted
- 15 Jun 2024
- Last updated
- 8 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Research subject's de-identified data will be shared through the National Institute of Mental Health Data Archive (NDA).
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06479980
- Acronym / sponsor ID
- STUDY00018612
- Conditions
- Mental Health Issue, HIV, Substance Use
- Keywords
- Brief narrative therapy, Implementation outcome, Stepped care, Psychotherapy, Integrated primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 28 Jun 2024 (actual)
- Results
- Posted 8 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Session Narrative Therapy Intervention | Experimental | Behavioral: Single Session Narrative TherapyA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Session Narrative TherapyAlso: Brief Narrative TherapySingle-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. | Behavioural | Single Session Narrative Therapy Intervention |
Primary outcome
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.
8 secondary outcomes
Generalized Anxiety Disorder- 7 (GAD-7)
Time frame: 1 month
Remoralization Scale
Time frame: 1 month
Social Connectedness Scale-Original (SCS-Original)
Time frame: 1 month
State-Trait Assessment of Resilience Scale (Trait Sub-scale Only)
Time frame: 1 month
Brief Services Evaluation
Time frame: 1 month
Acceptability of Intervention Measure (AIM)
Time frame: 1 Month for patient participants; 0 Month for referring providers
Intervention Appropriateness Measure (IAM)
Time frame: 0 Month for referring providers
Feasibility of Intervention Measure (FIM)
Time frame: 0 Month for referring providers
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Research subject's de-identified data will be shared through the National Institute of Mental Health Data Archive (NDA).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akansha Vaswani-Bye principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Session Narrative Therapy in people with Mental Health Issue and HIV, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 (PHQ-9) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.