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NCT Number: NCT05440214

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland

Baltimore, Maryland, 21201, United States

Location status: Recruiting

Location contact

Peter L Phalen

CONTACT

[email protected]

2063711107

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: DBT, DBT-ST, DBT Skills Group, Dialectical Behavior Therapy Skills Group

Primary outcomes

  1. Suicidal Ideation

    Time frame: Four months

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

  2. Emotion Dysregulation

    Time frame: Four months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Peter L Phalen, PsyD'

CONTACT

[email protected]

410-706-2490

Wendy Potts

CONTACT

[email protected]

410-706-6638

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 30, 2022
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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