Targeting Emotion Dysregulation to Reduce Suicide in People With Psychosis

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.

Study Overview

• Status: Recruiting
• Conditions: Suicide; Psychosis
• Intervention / Treatment: Behavioral: Dialectical Behavior Therapy Skills Training

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter L Phalen, PsyD'; Phone Number: 410-706-2490; Email: pphalen@som.umaryland.edu
• Study Contact Backup: Name: Wendy Potts; Phone Number: 410-706-6638; Email: wpotts@som.umaryland.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland
      • Contact: Peter L Phalen; Phone Number: 2063711107; Email: pphalen@som.umaryland.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment As Usual
Experimental: Dialectical Behavior Therapy - Skill Training	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.; Other Names: DBT; DBT-ST; DBT Skills Group; Dialectical Behavior Therapy Skills Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 23, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Behavioral Symptoms; Self-Injurious Behavior; Psychotic Disorders; Suicide; Mental Disorders
• Other Study ID Numbers: 1K23MH125024-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No