Targeting Emotion Dysregulation to Reduce Suicide in People With Psychosis

NCT ID: NCT05440214

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-02
• Study Completion Date: 2026-12-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dialectical Behavior Therapy - Skill Training

Group Type: EXPERIMENTAL

Dialectical Behavior Therapy Skills Training

Intervention Type: 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.

Treatment As Usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

DBT; DBT-ST; DBT Skills Group; Dialectical Behavior Therapy Skills Group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Peter Phalen

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Maryland

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Peter L Phalen, PsyD'

Role: CONTACT

pphalen@som.umaryland.edu

410-706-2490

Wendy Potts

Role: CONTACT

wpotts@som.umaryland.edu

410-706-6638

Facility Contacts

Peter L Phalen

Role: primary

pphalen@som.umaryland.edu

2063711107

Other Identifiers

1K23MH125024-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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