- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02904746
Intervention to Increase Treatment Engagement Among Individuals Referred for Post-Crisis Mental Health Services
A Brief, Trauma-Informed Intervention to Increase Treatment Engagement Among Individuals Referred for Post-Crisis Mental Health Services
Study Overview
Detailed Description
The current study will employ a quasi-experimental design whereby several frontline clinicians at a mental health crisis response will be trained to deliver the Make It! intervention and the others will not. An attempt will be made to train staff who commonly share work days or shifts in order to avoid details of the active intervention reaching clinicians who continue to deliver treatment as usual. For the duration of the study period, clinicians trained in Make It! will be instructed to use the intervention as their standard of care with all of the clients they assess whom are subsequently referred to the Information Class. The remaining clinicians will continue to use treatment as usual.
During a 90 minute workshop, Make It! will be introduced and modeled by the Principal Investigator (PI). Make It! consists of a 10-15 minute intervention with 5 components: 1) Acknowledgement that the client has experienced distressing events and/or very stressful situations, and that this exposure can lead to a range of reactions, 2) Client-generated, clinician-assisted, pros and cons of attending the Information Class, 3) Detailed visualization of the First Information in order to reduce anxiety about what to expect, 4) Expression of confidence that the client can begin progress towards the changes they want to make, 5) Reiteration of main information and appointment card given. Each clinician trained will be observed administering the intervention to a co-worker, with fidelity checks being implemented throughout the study period. These fidelity checks will be implemented by the PI, who will occasionally and sporadically observe the clinicians administer the intervention through a one-way mirror, with the verbal consent of the participant and the clinician.
All clients accessing the walk-in service at the crisis response centre currently receive a mental health assessment by a staff clinician. Throughout the course of the assessment, if the clinician perceives that the client may benefit from follow-up psychological services, he or she provides the client with an appointment date and time for the next available Information Class. The Information Class is a group appointment, and its purpose is to provide information about the services offered at the centre. It serves as the entryway into follow-up services such as cognitive behavioral therapy classes for mood and anxiety symptoms or dialectical behavioral therapy-informed classes. Walk-in clients who receive an appointment for this Information Class typically are given an appointment date that is within 1-2 weeks of their walk-in visit.
Once the clinician makes a decision to refer a client to an Information Class, the clinician will contact the study coordinator. The study coordinator or research volunteer will come into the interview room while the clinician steps out, will explain the study to the participant, and will obtain informed consent. In the event that a potential participant requires more time to consider whether he or she wants to consent to study participation, the individual will be provided with the contact information of the study coordinator in order to be able to consent at a later date. The study coordinator or research volunteer will also ask the participant to complete some brief questionnaires at this time assessing barriers to seeking mental health care and stages of change.
The study coordinator or research volunteer will then leave and the clinician will return to the interview room. If the clinician has not been trained in Make It!, he/she will proceed with care as usual. This condition involves providing the client with detailed information about the upcoming Information Class. If the clinician has been trained in Make It!, then the intervention will proceed at this time.
A few days before the client's Information Class, a reminder call is made by an administrative assistant at the centre. When the administrative assistant is unable to reach the client, she leaves a brief message, if possible to do so.
On the day of the Information Class, attendance will be taken. Clients sit in a classroom setting and complete a package of questionnaires. Those participants enrolled in the study will complete the Life Events Checklist-5, the University of Rhode Island Change Assessment, and an open-ended question assessing barriers to care, in addition to 5 questionnaires assessing a range of mental health symptoms that are already administered at the Information Class for clinical purposes. After the Information Class, clients have the opportunity to meet individually for 5-10 minutes with a staff member in order to discuss their treatment needs and preferences, and to connect them with subsequent services. If the client is a participant in the study, the staff member will provide them with a debriefing document that also contains the PI's contact information should they have any additional questions, comments, or concerns. This concludes the client's participation in the study.
For study participants who do not attend the Information Class, the questionnaires administered at the Information Class will be mailed to the participant along with a standard Information Class "no show" letter and the study's debriefing document. Participants will be encouraged to complete the questionnaires and return them in the self-addressed stamped envelope to the PI. This will represent the end of the participant's role in the study.
If a participant calls in advance of the Information Class to reschedule their Class date, or if they inform the administrative assistant that they wish to reschedule when she makes the reminder call, the participant will continued to be considered a participant until their rescheduled appointment.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0Y1
- Crisis Response Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Criteria for being referred to the crisis centre's Information Class and thus, for participation in the study are:
- presenting to the walk-in service with a mental health-related crisis (e.g., difficulty coping with acute stressors, suicidality),
- a willingness by the client to participate in class-based or group interventions,
- the ability to attend and have transportation to services during daytime hours,
- the client is not better served by another service for their presenting problem (e.g., Addictions Foundation of Manitoba when alcohol or substance is primary),
- the client is literate and will be able to understand and benefit from attending class-based or group psychotherapy interventions, and
- the client is not being admitted to the Crisis Stabilization Unit or hospital (i.e., is not at imminent risk of harming themselves or others).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control
Care as usual
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Experimental: Intervention
Participants receiving the Make It! intervention
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The Make It! motivational enhancement intervention has been informed by Motivational Interviewing principles, a method that has widely demonstrated effectiveness in increasing a number of positive behavior changes, including appointment adherence.
Make It! consists of a 10-15 minute intervention with 5 components: Common reactions to stressors that this exposure can lead to a range of reactions, pros and cons of attending the Information Class, visualization of the Information Class, expression of confidence that the client can progress towards change, and reiteration of main information.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Attendance status to Information Class
Time Frame: 1-2 weeks post enrollment in study
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1-2 weeks post enrollment in study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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University of Rhode Island Change Assessment (URICA)
Time Frame: Immediately following study enrolment and 1-2 weeks post enrollment in study
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Immediately following study enrolment and 1-2 weeks post enrollment in study
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Open-ended question regarding barriers to pursuing mental health services
Time Frame: Immediately following study enrollment and 1-2 weeks post enrollment in study (at Information Class)
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Immediately following study enrollment and 1-2 weeks post enrollment in study (at Information Class)
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Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 1-2 weeks post enrollment in study (at Information Class)
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1-2 weeks post enrollment in study (at Information Class)
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Generalized Anxiety Disorder Questionnaire (GAD-7)
Time Frame: 1-2 weeks post enrollment in study (at Information Class)
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1-2 weeks post enrollment in study (at Information Class)
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Posttraumatic Stress Disorder Checklist-5 (PCL-5)
Time Frame: 1-2 weeks post enrollment in study (at Information Class)
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1-2 weeks post enrollment in study (at Information Class)
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Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Cross-cutting Measure
Time Frame: 1-2 weeks post enrollment in study (at Information Class)
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1-2 weeks post enrollment in study (at Information Class)
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Difficulties in Emotion Regulation Scale (DERS)
Time Frame: 1-2 weeks post enrollment in study (at Information Class)
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1-2 weeks post enrollment in study (at Information Class)
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Age
Time Frame: To be extracted from client's medical record immediately following enrolment in study
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To be extracted from client's medical record immediately following enrolment in study
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Gender
Time Frame: To be extracted from client's medical record immediately following enrolment in study
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To be extracted from client's medical record immediately following enrolment in study
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Marital status
Time Frame: To be extracted from client's medical record immediately following enrolment in study
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To be extracted from client's medical record immediately following enrolment in study
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Employment status
Time Frame: To be extracted from client's medical record immediately following enrolment in study
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To be extracted from client's medical record immediately following enrolment in study
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Presenting problem at walk-in visit to crisis centre
Time Frame: To be extracted from client's medical record immediately following enrolment in study
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To be extracted from client's medical record immediately following enrolment in study
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Natalie Mota, PhD, University of Manitoba
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
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
- H2016:124
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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