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Practice Experiences for School Reintegration (PrESR)

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Completed

Conditions

Suicide

Treatments

Behavioral: VR Enhanced Affect Regulation
Behavioral: VR Enhanced Cognitive Restructuring
Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets
Behavioral: VR Enhanced Problem Solving
Behavioral: Safety Planning

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05934396
20-3464
5K23MH122775 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study is developing and refining a novel Virtual Reality (VR) supplement for inpatient treatment: the Practice Experiences for School Reintegration (PrESR) program. The PrESR will provide immersive school experiences for inpatient adolescents (with suicidal-related admissions) to practice skills in real-world settings with the guidance of a trained clinician within the confines of a hospital. This pilot study follows a Multiphase Optimization Strategy (MOST) to conduct a pilot optimization trial of the PrESR to inform the feasibility of training clinicians, the ability to recruit adolescent inpatient participants, and management of experimental conditions. This study is not powered to test hypotheses; however, in addition to assessing feasibility and acceptability, this pilot trial will assess candidate intermediary and outcome measures.

Full description

This study follows a multiphased optimization (MOST) research design; this clinical trial is considered to be a pilot optimization component of the MOST framework. For the present study, a prospective sample of adolescents hospitalized for suicidal thoughts and behaviors will be randomly selected into one of 8 experimental conditions (N=5-6 per group). Although the intervention for the pilot optimization trial will be implemented by a member of research staff, this study will also aim to recruit 2-5 clinicians to deliver the full intervention to a separate sample of adolescent patients to inform acceptability and feasibility of the intervention within their clinical workflow.

Enrollment

54 patients

Sex

All

Ages

13 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adolescent Participants:

  • current hospitalization for suicidal thoughts and behaviors
  • ages 13-18
  • expected return to school following discharge
  • ability to speak, read, and understand English sufficiently to complete study procedures,
  • consent of a parent/legal guardian (in English or Spanish; for minor participants)
  • adolescent assent or consent (in English)
  • clinician approval.

Hospital professionals:

  • Works as a clinician at the hospital site who delivers treatment including CBT to hospitalized adolescents,
  • Hospital professional consent (in English)
  • consent of patient's parent/legal guardian (in English or Spanish; for minor participants)
  • adolescent patient assent or consent (in English).

Exclusion criteria

Adolescent Participants

  • evidence of active psychosis,
  • evidence of intellectual disability
  • Risk for Cyber-sickness (greater than or equal to 50th percentile as measured on the Motion Sickness Susceptibility Questionnaire)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

54 participants in 8 patient groups

Enhanced Control
Active Comparator group
Description:
Cognitive Behavioral Therapy (CBT) Worksheets
Treatment:
Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets
Affect Regulation
Active Comparator group
Description:
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation
Treatment:
Behavioral: Safety Planning
Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets
Behavioral: VR Enhanced Affect Regulation
Problem Solving
Active Comparator group
Description:
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Problem Solving
Treatment:
Behavioral: Safety Planning
Behavioral: VR Enhanced Problem Solving
Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets
Affect Regulation + Problem Solving
Active Comparator group
Description:
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving
Treatment:
Behavioral: Safety Planning
Behavioral: VR Enhanced Problem Solving
Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets
Behavioral: VR Enhanced Affect Regulation
Cognitive Restructuring
Active Comparator group
Description:
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring
Treatment:
Behavioral: Safety Planning
Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets
Behavioral: VR Enhanced Cognitive Restructuring
Affect Regulation + Cognitive Restructuring
Active Comparator group
Description:
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring
Treatment:
Behavioral: Safety Planning
Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets
Behavioral: VR Enhanced Cognitive Restructuring
Behavioral: VR Enhanced Affect Regulation
Cognitive Restructuring + Problem Solving
Active Comparator group
Description:
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
Treatment:
Behavioral: Safety Planning
Behavioral: VR Enhanced Problem Solving
Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets
Behavioral: VR Enhanced Cognitive Restructuring
Affect Regulation + Cognitive Restructuring + Problem Solving
Active Comparator group
Description:
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
Treatment:
Behavioral: Safety Planning
Behavioral: VR Enhanced Problem Solving
Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets
Behavioral: VR Enhanced Cognitive Restructuring
Behavioral: VR Enhanced Affect Regulation

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Marisa E Marraccini, PhD

Data sourced from clinicaltrials.gov

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