Brief Cognitive Behavioral Therapy for People With Physical Disabilities
Primary Purpose
Suicide, Suicide, Attempted, Suicidal Ideation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Cognitive Behavioral Therapy for People with Physical Disabilities
Sponsored by
About this trial
This is an interventional treatment trial for Suicide
Eligibility Criteria
Inclusion Criteria: 18 years of age Disability impacting vision, hearing, or mobility Past-week suicidal ideation or past-month suicide attempt Exclusion Criteria: Inability to provide informed consent Lack of internet connection and web camera
Sites / Locations
- The Ohio State Universitty Wexner Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Brief Cognitive Behavioral Therapy for People with Physical Disabilities
Arm Description
Outcomes
Primary Outcome Measures
Scaler for Suicide Ideation
Past-week suicidal ideation severity
Secondary Outcome Measures
Self-Injurious Thoughts and Behaviors Interview-Revised
Suicide attempt since last assessment
Full Information
NCT ID
NCT05695430
First Posted
November 17, 2022
Last Updated
January 12, 2023
Sponsor
Ohio State University
Collaborators
American Foundation for Suicide Prevention
1. Study Identification
Unique Protocol Identification Number
NCT05695430
Brief Title
Brief Cognitive Behavioral Therapy for People With Physical Disabilities
Official Title
Telehealth-delivered Brief Cognitive Behavioral Therapy to Prevent Suicides in People With Physical Disabilities
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
American Foundation for Suicide Prevention
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to examine the effectiveness of a psychotherapy (non-medication) treatment, Brief Cognitive Behavioral Therapy for Suicide Prevention, in reducing suicide ideation and attempts for people with physical disabilities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Suicide, Attempted, Suicidal Ideation, Disability Physical, Disability Hearing, Disability, Vision
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Brief Cognitive Behavioral Therapy for People with Physical Disabilities
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Brief Cognitive Behavioral Therapy for People with Physical Disabilities
Intervention Description
12 sessions of of Brief Cognitive Behavioral Therapy that has been adapted for people with physical disabilities will be administered through telehelath.
Primary Outcome Measure Information:
Title
Scaler for Suicide Ideation
Description
Past-week suicidal ideation severity
Time Frame
Weekly change through treatment completion, an average of 3 months
Secondary Outcome Measure Information:
Title
Self-Injurious Thoughts and Behaviors Interview-Revised
Description
Suicide attempt since last assessment
Time Frame
Through treatment completion, an average of 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age
Disability impacting vision, hearing, or mobility
Past-week suicidal ideation or past-month suicide attempt
Exclusion Criteria:
Inability to provide informed consent
Lack of internet connection and web camera
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren R Khazem, PhD
Phone
614-366-1027
Email
lauren.khazem@osumc.edu
Facility Information:
Facility Name
The Ohio State Universitty Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren R Khazem
Phone
614-366-2294
Email
lauren.khazem@osumc.edu
12. IPD Sharing Statement
Learn more about this trial
Brief Cognitive Behavioral Therapy for People With Physical Disabilities
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