Back to resultsTargeting Emotion Dysregulation to Reduce Suicide in People With Psychosis
Primary Purpose
Psychosis, Suicide
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dialectical Behavior Therapy Skills Training
Sponsored by
About this trial
This is an interventional treatment trial for Psychosis
Eligibility Criteria
Inclusion Criteria:
- At least 18 years old
- Psychosis spectrum disorder as assessed by the Mini International Neuropsychiatric Interview (MINI) for Psychotic Disorder Studies
- Heightened suicide risk as determined by a score of 8+ on the Suicide Behaviors Questionnaire-Revised (SBQ-R). This cutoff may be revised downwards (toward lower suicide risk) if recruitment appears difficult, but will not be revised upwards.
- Enrollment and engagement in outpatient mental health services with at least one mental health service in the previous month
- 6+ grade equivalent reading level as assessed by the Wide Range Achievement Test 4 (WRAT-4)
Exclusion Criteria:
- Chart diagnosis of intellectual disability (DSM5 317, 318), traumatic brain injury, or deafness.
Sites / Locations
- University of MarylandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Dialectical Behavior Therapy - Skill Training
Treatment As Usual
Arm Description
Outcomes
Primary Outcome Measures
Suicidal Ideation
Beck Scale for Suicide Ideation. Minimum score: 0. Maximum score: 42. Higher scores are worse.
Emotion Dysregulation
Difficulties in Emotion Regulation Scale (DERS-36). Minimum score: 36. Maximum score: 180. Higher scores are worse.
Secondary Outcome Measures
Full Information
NCT ID
NCT05440214
First Posted
June 27, 2022
Last Updated
September 11, 2023
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT05440214
Brief Title
Targeting Emotion Dysregulation to Reduce Suicide in People With Psychosis
Official Title
Targeting Emotion Dysregulation to Reduce Suicide in People With Psychosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2022 (Actual)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
People with psychotic disorders are excluded from most suicide-focused clinical trials despite incredibly high rates of completed suicide, and interventions that have been tested for this population have shown limited impact on suicide. Emotion dysregulation is a significant suicidogenic factor that is understudied in people with psychotic disorders. The investigators propose to implement and evaluate an intervention targeting emotion dysregulation in people with psychotic disorders while employing rigorous statistical modeling and measurement techniques including Ecological Momentary Assessment, which will support future advanced research on suicide and suicide prevention for this high-risk group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis, Suicide
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dialectical Behavior Therapy - Skill Training
Arm Type
Experimental
Arm Title
Treatment As Usual
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Dialectical Behavior Therapy Skills Training
Other Intervention Name(s)
DBT, DBT-ST, DBT Skills Group, Dialectical Behavior Therapy Skills Group
Intervention Description
Dialectical Behavior Therapy Skills Training (DBT-ST) is a group-based intervention focused on teaching skills for improving emotion regulation. The sessions will be offered in-person or via approved telehealth services.
Primary Outcome Measure Information:
Title
Suicidal Ideation
Description
Beck Scale for Suicide Ideation. Minimum score: 0. Maximum score: 42. Higher scores are worse.
Time Frame
Four months
Title
Emotion Dysregulation
Description
Difficulties in Emotion Regulation Scale (DERS-36). Minimum score: 36. Maximum score: 180. Higher scores are worse.
Time Frame
Four months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 18 years old
Psychosis spectrum disorder as assessed by the Mini International Neuropsychiatric Interview (MINI) for Psychotic Disorder Studies
Heightened suicide risk as determined by a score of 8+ on the Suicide Behaviors Questionnaire-Revised (SBQ-R). This cutoff may be revised downwards (toward lower suicide risk) if recruitment appears difficult, but will not be revised upwards.
Enrollment and engagement in outpatient mental health services with at least one mental health service in the previous month
6+ grade equivalent reading level as assessed by the Wide Range Achievement Test 4 (WRAT-4)
Exclusion Criteria:
Chart diagnosis of intellectual disability (DSM5 317, 318), traumatic brain injury, or deafness.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter L Phalen, PsyD'
Phone
410-706-2490
Email
pphalen@som.umaryland.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Wendy Potts
Phone
410-706-6638
Email
wpotts@som.umaryland.edu
Facility Information:
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter L Phalen
Phone
206-371-1107
Email
pphalen@som.umaryland.edu
12. IPD Sharing Statement
Learn more about this trial
Targeting Emotion Dysregulation to Reduce Suicide in People With Psychosis
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