NCT03170934

Brief Summary

The proposed study will conduct a preliminary investigation of the effectiveness of two different psychotherapy classes at the Mental Health Crisis Response Centre (CRC) in reducing suicidal ideation. One class - Managing Difficult Emotions (MDE) - is an 8-session, Dialectical Behavioral Therapy-informed program that focuses on skills related to increasing tolerance for distress and emotion regulation such that harmful behaviors are reduced. The other class - Mindfulness-Based Cognitive Behavioral Therapy (CBTm) - is a 4-session program that focuses on challenging and changing maladaptive beliefs and behaviors in order to reduce distress. Both classes are delivered in lecture style, PowerPoint format. The investigators will also examine the effectiveness of participation in psychotherapy classes in reducing symptoms of general psychological distress, depression, anxiety, and emotion dysregulation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

May 31, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

1.4 years

First QC Date

May 23, 2017

Last Update Submit

April 20, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Suicidal ideation

    Current suicidal thinking, as defined by the Beck Scale for Suicidal Ideation

    Change from baseline (information class) to class completion or drop-out (either at 4 or 8 weeks, depending on the class being completed)

Secondary Outcomes (4)

  • Anxiety symptoms

    Change from baseline (information class) to class completion or drop-out (either at 4 or 8 weeks, depending on the class being completed)

  • Depression symptoms

    Change from baseline (information class) to class completion or drop-out (either at 4 or 8 weeks, depending on the class being completed).

  • Emotion regulation difficulties

    Change from baseline (information class) to class completion or drop-out (either at 4 or 8 weeks, depending on the class being completed)

  • General psychological distress

    Change from baseline (information class) to class completion or drop-out (either at 4 or 8 weeks, depending on the class being completed)

Interventions

Rapid access, large-scale, psychotherapy classes that are open format and delivered in lecture style. One class - Managing Difficult Emotions (MDE) - is an 8-session, DBT-informed program. The other class - Mindfulness-Based Cognitive Behavioral Therapy (CBTm) - is a 4-session program.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study population is patients aged 18 years and older who access care at Manitoba's Crisis Response Centre or at a local emergency department and who have been referred to the CRC's UFITT program. Patients who are deemed by CRC staff as potentially benefitting from UFITT programming are asked to attend an Information Session where they are told about crisis follow-up services and in particular, the two psychotherapy classes available. It is those individuals who choose to be enrolled in one of these classes upon attending an Information Session who will be recruited for the proposed study.

You may qualify if:

  • Person has been referred to the UFITT program following a mental health crisis
  • years of age or older
  • Fluent in English
  • Ability to understand and read class material
  • Ability to independently complete questionnaires
  • Has a contact telephone number

You may not qualify if:

  • Mental health needs better served by other community resources (e.g., a severe primary substance use disorder, intimate partner violence)
  • At immediate risk of harming self or others
  • Active psychotic symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Crisis Response Centre

Winnipeg, Manitoba, R3E 0W2, Canada

Location

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor/Staff Psychologist

Study Record Dates

First Submitted

May 23, 2017

First Posted

May 31, 2017

Study Start

May 31, 2017

Primary Completion

October 30, 2018

Study Completion

October 30, 2018

Last Updated

April 23, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations