- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07116655
- Original Trial
Feasibility Study of Single-session Solution Focused Consultation to Enhance Treatment Engagement
Improving Mental Health Treatment Engagement of Patients With Comorbid Chronic Diseases: A Randomized Controlled Evaluation of the Feasibility and Preliminary Effectiveness of a Single-Session Solution-Focused Consultation (SSC) in a Community Setting
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jacqueline L. Tilley, PhD
- Phone Number: +65 67903202
- Email: jacqueline.tilley@nie.edu.sg
Study Locations
-
-
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Singapore, Singapore
- Recruiting
- Renal Health Services
-
Contact:
- Behram A. Khan, MBBS, MD
- Email: admin@renalhealthservices.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: 1. A history of one or more chronic physical diseases based on the Ministry of Health (Singapore) Chronic Disease Management Programme guidelines; 2. A score of 5 or more on the Patient Health Questionnaire (PHQ-9) or Generalized Anxiety Disorder-7 (GAD-7); 3. Not currently engaged in formal mental health service; 4. Conversant in the English language; 5. Receiving treatment in a community healthcare setting
Exclusion Criteria: 1. A history of psychosis, intellectual disability, or pervasive developmental disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Active Control Group
Single-session supportive therapy based approach
|
In the supportive consultation session, the interventionist will allow the participant to decide what they wish to discuss during the session and listen empathetically, validate their feelings and offer reassurance to the patient.
The exact wording or questions will vary depending on the client's needs and sharing.
|
|
Experimental: Intervention Group
Single-session solution-focused therapy based approach
|
In the SSC, the interventionist first sets expectations, explaining that the session is a means of providing short-term support.
The interventionist will then praise the participant for agreeing to receive support and introduce the Action Plan, which will guide the session's structure.
The interventionist will then work with the participant to (1) identify a specific, modifiable issue they are facing; (2) use the "miracle question" to envision their ideal outcome where the problem is resolved, and rates their current proximity to that; (3) determine the "smallest possible step" they can take towards this outcome through a scaling exercise; and (4) develop a personalized action plan that leverage on their current resources to begin addressing the problem.
Upon ending the SSC, the interventionist writes a personalized note to the participant, highlighting their strengths and expressing confidence in their ability to follow through.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment Engagement - Uptake
Time Frame: Post-intervention (immediate)
|
Endorsement of interest in referral for mental health services or follow-up session with interventionist
|
Post-intervention (immediate)
|
|
Treatment engagement - Attendance
Time Frame: 2-weeks post-intervention
|
Attendance at intake session for mental health services or follow-up session with interventionist
|
2-weeks post-intervention
|
|
Feasibility - Intervention Completion Rate
Time Frame: Post-intervention (immediate)
|
Completion of intervention action plans
|
Post-intervention (immediate)
|
|
Acceptability - Usefulness of intervention
Time Frame: Post-intervention (immediate)
|
Single item measure on helpfulness of consultation in addressing concern/s
|
Post-intervention (immediate)
|
|
Acceptability - Satisfaction with outcome
Time Frame: Post-intervention (immediate)
|
Single item measure on how satisfied they are with the intervention's outcome
|
Post-intervention (immediate)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived agency
Time Frame: From baseline to post-intervention (immediate)
|
State Hope Scale (SHS) - Pathways Subscale
|
From baseline to post-intervention (immediate)
|
|
Hope
Time Frame: From baseline to post-intervention (immediate) and two-week post intervention
|
Beck's Hopelessness Scale (BHS-4)
|
From baseline to post-intervention (immediate) and two-week post intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression
Time Frame: From baseline to two-weeks post intervention
|
Patient's Health Questionnaire (PHQ-9)
|
From baseline to two-weeks post intervention
|
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Anxiety
Time Frame: From baseline to two-weeks post intervention
|
Generalized Anxiety Disorder (GAD-7)
|
From baseline to two-weeks post intervention
|
|
Change readiness
Time Frame: From baseline to post-intervention (immediate) and two-week post intervention
|
Readiness Ruler
|
From baseline to post-intervention (immediate) and two-week post intervention
|
|
Life satisfaction
Time Frame: From baseline to two-week post intervention
|
Single-item measuring satisfaction with life
|
From baseline to two-week post intervention
|
|
Perceived current health status
Time Frame: From baseline to two-week post intervention
|
Single-item measuring perceived current health status
|
From baseline to two-week post intervention
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB-2024-777
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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