Targeting Emotion Dysregulation to Reduce Suicide in People With Psychosis

Suicide Clinical Trial

Official title:

Targeting Emotion Dysregulation to Reduce Suicide in People With Psychosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05440214
• Other study ID #: 1K23MH125024-01A1
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: September 2023
• Source: University of Maryland, Baltimore
• Contact: Peter L Phalen, PsyD'
• Phone: 410-706-2490
• Email: pphalen[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: June 30, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders
• Suicide

Intervention

Behavioral:
• Dialectical Behavior Therapy Skills Training
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.

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suicidal Ideation	Beck Scale for Suicide Ideation. Minimum score: 0. Maximum score: 42. Higher scores are worse.	Four months
Primary	Emotion Dysregulation	Difficulties in Emotion Regulation Scale (DERS-36). Minimum score: 36. Maximum score: 180. Higher scores are worse.	Four months