Recruiting

Emotion Dysregulation

Sponsor:

University of Maryland, Baltimore

Code:

NCT05440214

Conditions

Psychosis

Suicide

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dialectical Behavior Therapy Skills Training

Study Details

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 ID

NCT05440214

Start date

Dec 2, 2022

Status verified date

Jul, 2025

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dialectical Behavior Therapy - Skill Training

no intervention: Treatment As Usual

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.

Primary outcome measure

  • Suicidal Ideation [ Time Frame: Four months ]
  • Emotion Dysregulation [ Time Frame: Four months ]

Central Contacts and Locations

Central contacts

Peter L Phalen, PsyD'

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

Wendy Potts

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

Locations

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Peter L Phalen

2063711107pphalen@som.umaryland.edu

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Jul 28, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2025-07-28.