NCT04280614

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?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

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

February 19, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2021

Completed
Last Updated

August 5, 2021

Status Verified

August 1, 2021

Enrollment Period

2 months

First QC Date

February 19, 2020

Last Update Submit

August 4, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self-harm, emotional distress, depression, anxiety

    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.

    Roughly 8 weeks.

Interventions

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.

Also known as: cognitive behaviour therapy (CBT)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • years and older

You may not qualify if:

  • declined by the STAT Program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Science Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

MeSH Terms

Interventions

Dialectical Behavior TherapyCognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2020

First Posted

February 21, 2020

Study Start

December 1, 2020

Primary Completion

February 1, 2021

Study Completion

March 17, 2021

Last Updated

August 5, 2021

Record last verified: 2021-08

Locations