- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00081367
Community-Based Cognitive Therapy for Suicide Attempters
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive behavioral therapy (CBT) + standard care
Participants will receive ten weekly sessions of treatment plus standard care for suicide prevention.
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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.
Participants will receive standard care for suicide prevention.
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Active Comparator: Standard care alone
Participants will receive standard care for suicide prevention.
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Participants will receive standard care for suicide prevention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Repeat suicide attempts
Time Frame: Measured during treatment and 1, 3, 6, 12, 18, and 24 months after study completion
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Measured during treatment and 1, 3, 6, 12, 18, and 24 months after study completion
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH067805 (U.S. NIH Grant/Contract)
- DSIR 83-ATP (NCT00719979)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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