Mental Health CrisisNCT02904746
Intervention to Increase Treatment Engagement Among Individuals Referred for Post-Crisis Mental Health Services
A study testing Make It! in people with Mental Health Crisis, run by University of Manitoba at 1 site in Canada.
Trial summary
This study will evaluate the preliminary effectiveness of Make It!, a single 15-minute intervention aimed at increasing attendance to a follow-up appointment for psychological services (i.e., an information class) among clients accessing walk-in services at a mental health crisis response centre. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health Crisis
- What is being tested?
- Make It!
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Brief, Trauma-Informed Intervention to Increase Treatment Engagement Among Individuals Referred for Post-Crisis Mental Health Services
This study will evaluate the preliminary effectiveness of Make It!, a single 15-minute intervention aimed at increasing attendance to a follow-up appointment for psychological services (i.e., an information class) among clients accessing walk-in services at a mental health crisis response centre. As a secondary aim, we will examine the demographic correlates, presenting problems, and symptom correlates of clients who do and do not attend follow-up services.
Read the 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.
- Conditions
- Mental Health Crisis
- Being tested
- Make It!
- Keywords
- follow-up, mental health appointment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Make It!Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants receiving the Make It! intervention Receives: Behavioral: Make It! |
| Control | No intervention | Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance status to Information Class
Measured: 1-2 weeks post enrollment in study
Secondary outcomes (12)
University of Rhode Island Change Assessment (URICA)
Measured: Immediately following study enrolment and 1-2 weeks post enrollment in study
Open-ended question regarding barriers to pursuing mental health services
Measured: Immediately following study enrollment and 1-2 weeks post enrollment in study (at Information Class)
Patient Health Questionnaire-9 (PHQ-9)
Measured: 1-2 weeks post enrollment in study (at Information Class)
Generalized Anxiety Disorder Questionnaire (GAD-7)
Measured: 1-2 weeks post enrollment in study (at Information Class)
Posttraumatic Stress Disorder Checklist-5 (PCL-5)
Measured: 1-2 weeks post enrollment in study (at Information Class)
Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Cross-cutting Measure
Measured: 1-2 weeks post enrollment in study (at Information Class)
Difficulties in Emotion Regulation Scale (DERS)
Measured: 1-2 weeks post enrollment in study (at Information Class)
Age
Measured: To be extracted from client's medical record immediately following enrolment in study
Gender
Measured: To be extracted from client's medical record immediately following enrolment in study
Marital status
Measured: To be extracted from client's medical record immediately following enrolment in study
Employment status
Measured: To be extracted from client's medical record immediately following enrolment in study
Presenting problem at walk-in visit to crisis centre
Measured: To be extracted from client's medical record immediately following enrolment in study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: Unable to successfully recruit participants using current study design.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health CrisisStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalie Mota, University of Manitoba
- Investigators
- Natalie Mota, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904746
- Sponsor's protocol ID
- H2016:124
- Status last verified
- May 2017
- First submitted
- 7 Sep 2016
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief, Trauma-Informed Intervention to Increase Treatment Engagement Among Individuals Referred for Post-Crisis Mental Health Services
- ClinicalTrials.gov ID
- NCT02904746
- Acronym / sponsor ID
- H2016:124
- Conditions
- Mental Health Crisis
- Keywords
- follow-up, mental health appointment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to successfully recruit participants using current study design.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the preliminary effectiveness of Make It!, a single 15-minute intervention aimed at increasing attendance to a follow-up appointment for psychological services (i.e., an information class) among clients accessing walk-in services at a mental health crisis response centre. As a secondary aim, we will examine the demographic correlates, presenting problems, and symptom correlates of clients who do and do not attend follow-up services.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Make It!Participants receiving the Make It! intervention |
| Control | No intervention | –Care as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not 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 |
|---|---|---|
| Make It!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. | Behavioural | Intervention |
Primary outcome
Attendance status to Information Class
Time frame: 1-2 weeks post enrollment in study
12 secondary outcomes
University of Rhode Island Change Assessment (URICA)
Time frame: Immediately following study enrolment and 1-2 weeks post enrollment in study
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)
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 1-2 weeks post enrollment in study (at Information Class)
Generalized Anxiety Disorder Questionnaire (GAD-7)
Time frame: 1-2 weeks post enrollment in study (at Information Class)
Posttraumatic Stress Disorder Checklist-5 (PCL-5)
Time frame: 1-2 weeks post enrollment in study (at Information Class)
Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Cross-cutting Measure
Time frame: 1-2 weeks post enrollment in study (at Information Class)
Difficulties in Emotion Regulation Scale (DERS)
Time frame: 1-2 weeks post enrollment in study (at Information Class)
Age
Time frame: To be extracted from client's medical record immediately following enrolment in study
Gender
Time frame: To be extracted from client's medical record immediately following enrolment in study
Marital status
Time frame: To be extracted from client's medical record immediately following enrolment in study
Employment status
Time frame: To be extracted from client's medical record immediately following enrolment in study
Presenting problem at walk-in visit to crisis centre
Time frame: To be extracted from client's medical record immediately following enrolment in study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Natalie Mota, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Make It! in people with Mental Health Crisis, run by University of Manitoba at 1 site in Canada.
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: withdrawn, as of the sponsor's last update on 12 Mar 2018. 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 Canada. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Attendance status to Information Class (time frame: 1-2 weeks post enrollment in study). 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 12 Mar 2018.