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Day Hospital Treatment of Emotional Dysregulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04280614
Recruitment Status : Completed
First Posted : February 21, 2020
Last Update Posted : August 5, 2021
Sponsor:
Information provided by (Responsible Party):
Daryl Croft, University of Manitoba

Brief Summary:

Objective: The goal of this proposed research project is a quantitative analysis of a day hospital program designed to treat persons with emotional dysregulation.

Background: The Short-term Assessment and Treatment (STAT) program has been operating at Health Sciences Center, Winnipeg, Manitoba for many decades. The STAT program is based on the principles of dialectical and cognitive behavior therapy. The STAT program is a five week day hospital program employing multi-modal treatment methods to treat patients with emotional dysregulation. The literature provides evidence of numerous treatment models with varying effectiveness for this population of patients. The STAT program hasn't had a quantitative analysis of its treatment model.

Problem Statement: Is the 5 week day hospital treatment model developed and employed by the STAT program effective in improving the mental health of participants admitted to the program?


Condition or disease Intervention/treatment
Emotional Dysfunction Behavioral: Dialectical behaviour therapy (DBT)

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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Day Hospital Treatment of Emotional Dysregulation: A Quantitative Analysis
Actual Study Start Date : December 1, 2020
Actual Primary Completion Date : February 1, 2021
Actual Study Completion Date : March 17, 2021

Intervention Details:
  • Behavioral: Dialectical behaviour therapy (DBT)
    DBT is based on the behavioural therapy principals focusing on four main modules: mindfulness, interpersonal effectiveness, emotional regulation and distress tolerance. The therapy is taught in a group and individual therapy model with coaching during periods of crisis. CBT is a standard model of therapy similar to DBT but is more direct in focusing clients on changing maladaptive behaviours or thoughts to effectively manage difficult emtions.
    Other Name: cognitive behaviour therapy (CBT)


Primary Outcome Measures :
  1. Self-harm, emotional distress, depression, anxiety [ Time Frame: Roughly 8 weeks. ]
    The Symptom-Checklist-90-Revised is a psychometric measure used in research and clinical settings in measurement of outcomes related to treatment. It measures global severity of mental illness, positive symptom distress index, positive symptom total as well as nine dimensions of psychopathology on a 0 - 4 scale. Previous research studies on therapeutic interventions involving BPD participants have used the SCL-90-R to measure outcome. The SCL-90-R will be used to assess if the participants self-report a decrease in the severity of global indices of mental illness and nine specific psychopathology factors. Gratz and Roemer (2004) developed the Difficulties in Emotion Regulation Scale (DERS), a 36 item self-report survey to assess emotion dysregulation on six domains. DERS has good test-retest reliability and high internal consistency.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Participants are referred to the STAT program through emergency room consultations, family physician referrals and from psychiatrists working in the community, outpatient department or during an inpatient admission. Most potential participants live within the catchment of Winnipeg.
Criteria

Inclusion Criteria:

  • 18 years and older

Exclusion Criteria:

  • declined by the STAT Program

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04280614


Locations
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Canada, Manitoba
Health Science Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Sponsors and Collaborators
University of Manitoba
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Responsible Party: Daryl Croft, Principal Investigator, University of Manitoba
ClinicalTrials.gov Identifier: NCT04280614    
Other Study ID Numbers: H2019:485
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: August 5, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It's unclear to what extent my thesis will be shared. The intent at this juncture is to present the data as a whole and not identify individual participant data in dissemination. Further discussion with my thesis advisor and the thesis advisory team is ongoing.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No