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VR-Enhanced CBT for Suicidal Behavior (PrESR Trial)
N/A
Recruiting
Led By Marisa Marraccini, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3-months following school re-entry
Awards & highlights
PrESR Trial Summary
This trial is developing a VR program to help hospitalized teens with suicidal-related admissions practice skills in "real-world" settings, under the guidance of a trained clinician.
Who is the study for?
This trial is for adolescents aged 13-18 hospitalized for suicidal thoughts or behaviors, who are expected to return to school after discharge. They must understand English well enough for study procedures and have their parent's consent. Clinicians at the hospital delivering CBT can also participate with consent. Those with a high risk of cyber-sickness, active psychosis, or intellectual disability cannot join.Check my eligibility
What is being tested?
The trial is testing a new VR-based program called PrESR designed to help inpatient teens practice coping skills in virtual school settings under clinician guidance. It aims to refine this tool by assessing its feasibility, training clinicians on its use, recruiting participants, and managing conditions within a hospital environment.See study design
What are the potential side effects?
Potential side effects may include cyber-sickness (similar to motion sickness) due to VR usage. However, those at high risk for this condition are excluded from the trial.
PrESR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3-months following school re-entry
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3-months following school re-entry
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adolescents' Mean Acceptability Scores
Adolescents' Perceptions of Acceptability
Average number of hours to complete assessments at each time point
+7 morePrESR Trial Design
8Treatment groups
Active Control
Group I: Affect RegulationActive Control3 Interventions
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation
Group II: Problem SolvingActive Control3 Interventions
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Problem Solving
Group III: Affect Regulation + Problem SolvingActive Control4 Interventions
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving
Group IV: Cognitive RestructuringActive Control3 Interventions
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring
Group V: Affect Regulation + Cognitive RestructuringActive Control4 Interventions
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring
Group VI: Cognitive Restructuring + Problem SolvingActive Control4 Interventions
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
Group VII: Affect Regulation + Cognitive Restructuring + Problem SolvingActive Control5 Interventions
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
Group VIII: Enhanced ControlActive Control1 Intervention
Cognitive Behavioral Therapy (CBT) Worksheets
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Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,661 Total Patients Enrolled
112 Trials studying Suicide
1,156,771 Patients Enrolled for Suicide
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,190,777 Total Patients Enrolled
3 Trials studying Suicide
1,797 Patients Enrolled for Suicide
Marisa Marraccini, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a clinician providing CBT to hospitalized teens.I am currently hospitalized due to suicidal thoughts and behaviors.I am between 13 and 18 years old.I am a teenager and I have agreed to participate.I, or my adolescent patient, can agree to participate in English.My parent or guardian has agreed to my participation in the study.My parent or legal guardian has given consent for me to participate.I am a student planning to return to school after my hospital stay.
Research Study Groups:
This trial has the following groups:- Group 1: Affect Regulation
- Group 2: Problem Solving
- Group 3: Affect Regulation + Problem Solving
- Group 4: Cognitive Restructuring
- Group 5: Affect Regulation + Cognitive Restructuring
- Group 6: Cognitive Restructuring + Problem Solving
- Group 7: Affect Regulation + Cognitive Restructuring + Problem Solving
- Group 8: Enhanced Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who qualifies as a potential participant in this investigation?
"Those hoping to join this research study must have a history of suicidal ideation and be aged between 13 and 18. Forty-eight applicants are required in total."
Answered by AI
Are participants being recruited for this research project right now?
"Clinicaltrials.gov reveals that this medical trial, which was originally posted on July 1st 2023 and last edited June 28th 2023 is no longer looking for participants. However, there are 182 other clinical trials presently recruiting patients in the area."
Answered by AI
Does the age of seventy preclude elderly individuals from participating in this trial?
"Participants in this research must be between 13 and 18 years old. 62 studies are open to younger patients while 123 trials cater for those over 65."
Answered by AI
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