Targeting Emotion Dysregulation to Reduce Suicide in People With Psychosis

NCT05440214 | Recruiting DMC

• 1 other identifier: 1K23MH125024-01A1
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychosis; Suicide

Outcome Measures

Primary Outcomes (2)

• Suicidal Ideation

  Beck Scale for Suicide Ideation. Minimum score: 0. Maximum score: 42. Higher scores are worse.

  Four months

• Emotion Dysregulation

  Difficulties in Emotion Regulation Scale (DERS-36). Minimum score: 36. Maximum score: 180. Higher scores are worse.

  Four months

Study Arms (2)

Dialectical Behavior Therapy - Skill Training

EXPERIMENTAL

Behavioral: Dialectical Behavior Therapy Skills Training

Treatment As Usual

NO INTERVENTION

Interventions

Dialectical Behavior Therapy Skills Training BEHAVIORAL

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.

Also known as: DBT, DBT-ST, DBT Skills Group, Dialectical Behavior Therapy Skills Group

Dialectical Behavior Therapy - Skill Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• + grade equivalent reading level as assessed by the Wide Range Achievement Test 4 (WRAT-4)

You may not qualify if:

• Chart diagnosis of intellectual disability (DSM5 317, 318), traumatic brain injury, or deafness.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders; Suicide

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Central Study Contacts

Peter L Phalen, PsyD'

CONTACT

410-706-2490; pphalen@som.umaryland.edu

Wendy Potts

CONTACT

410-706-6638; wpotts@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: June 30, 2022
• Study Start: December 2, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)