Community-Based Cognitive Therapy for Suicide Attempters
Primary Purpose
Suicide, Attempted
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CBT
Standard care alone
Sponsored by
About this trial
This is an interventional treatment trial for Suicide, Attempted focused on measuring Minority Groups
Eligibility Criteria
Inclusion Criteria: Suicide attempt within 48 hours prior to being evaluated at the hospital English speaking Able to provide 2 verifiable contacts Exclusion Criteria: Acute, unstable, or severe Axis III disorder or a severe Axis I disorder that may prevent safe participation in outpatient psychotherapy
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive behavioral therapy (CBT) + standard care
Standard care alone
Arm Description
Participants will receive ten weekly sessions of treatment plus standard care for suicide prevention.
Participants will receive standard care for suicide prevention.
Outcomes
Primary Outcome Measures
Repeat suicide attempts
Secondary Outcome Measures
Full Information
NCT ID
NCT00081367
First Posted
April 9, 2004
Last Updated
June 9, 2014
Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00081367
Brief Title
Community-Based Cognitive Therapy for Suicide Attempters
Official Title
Community-Based Cognitive Therapy for Suicide Attempters
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will determine the effectiveness of cognitive behavioral therapy (CBT) in preventing future suicide attempts in repeat suicide attempters.
Detailed Description
Rates of mental health and substance use disorders are high among economically disadvantaged, ethnic minority populations. Studies have shown that CBT designed for this high-risk population is successful at reducing suicide attempts in people with suicidal thoughts or attempts. This study will implement a CBT intervention into the community and will focus on increasing compliance with psychiatric, substance abuse, and medical treatment.
Participants in this study will be randomly assigned to receive either CBT plus standard care or standard care alone. Participants who receive CBT will have ten weekly sessions of treatment. Suicidal thoughts or attempts, hopelessness, depression, health care utilization, and overall psychological and social adaptation will be assessed. Assessments will be made 1, 3, 6, 12, 18, and 24 months after study completion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted
Keywords
Minority Groups
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive behavioral therapy (CBT) + standard care
Arm Type
Experimental
Arm Description
Participants will receive ten weekly sessions of treatment plus standard care for suicide prevention.
Arm Title
Standard care alone
Arm Type
Active Comparator
Arm Description
Participants will receive standard care for suicide prevention.
Intervention Type
Behavioral
Intervention Name(s)
CBT
Intervention Description
Participants will receive ten weekly sessions of treatment. Suicidal thoughts or attempts, hopelessness, depression, health care utilization, and overall psychological and social adaptation will be assessed.
Intervention Type
Behavioral
Intervention Name(s)
Standard care alone
Intervention Description
Participants will receive standard care for suicide prevention.
Primary Outcome Measure Information:
Title
Repeat suicide attempts
Time Frame
Measured during treatment and 1, 3, 6, 12, 18, and 24 months after study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Suicide attempt within 48 hours prior to being evaluated at the hospital
English speaking
Able to provide 2 verifiable contacts
Exclusion Criteria:
Acute, unstable, or severe Axis III disorder or a severe Axis I disorder that may prevent safe participation in outpatient psychotherapy
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16077050
Citation
Brown GK, Ten Have T, Henriques GR, Xie SX, Hollander JE, Beck AT. Cognitive therapy for the prevention of suicide attempts: a randomized controlled trial. JAMA. 2005 Aug 3;294(5):563-70. doi: 10.1001/jama.294.5.563.
Results Reference
background
PubMed Identifier
33884617
Citation
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
Results Reference
derived
Learn more about this trial
Community-Based Cognitive Therapy for Suicide Attempters
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