- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00218725
Effectiveness of Cognitive Therapy for Suicide Attempters With Drug Dependence Disorder
Cognitive Therapy for Suicide Attempters With Drug Dependence Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Suicide attempts involving drug abuse are a major public health problem. Development of interventions that focus on reducing the suicide attempt rate among drug abusers is a necessity. There is a strong connection between drug abuse and both suicide attempts and completed suicide. As much as 45% of drug abusers have attempted suicide at least once. The rate of completed suicide among drug abusers has been reported to be as much as 30 times the rate for the general population. Unfortunately, there is a lack of empirically supported treatments for reducing suicidal behavior in drug abusers. This study will develop and evaluate the effectiveness of a cognitive therapy intervention for people with a drug dependence disorder who recently attempted suicide.
Participants in this single-blind study will be randomly assigned to one of two treatment groups: cognitive therapy combined with enriched usual care; or enriched usual care alone. An initial baseline assessment will occur within 7 days following the participant's suicide attempt and subsequent medical evaluation at a hospital emergency department. Suicide behavior and ideation, depression, hopelessness, and addiction severity will be assessed. Following the baseline assessment, treatment will begin. The cognitive therapy treatment will be specifically developed to prevent suicide attempts. It will involve the identification of proximal thoughts, images, and core beliefs that were activated prior to the suicide attempt. Cognitive and behavioral strategies will be applied to address the identified thoughts and beliefs. Patients will also learn adaptive ways of coping with stressors. The enriched usual care will entail standard treatments for suicide prevention. Study visits will occur 1, 3, 6, 12, 18, and 24 months following enrollment. Baseline measurements will be repeated at each study visit to evaluate participants' improvement. Participants receiving cognitive therapy will attend approximately 10 weekly or bi-weekly outpatient study visits. Participation will last for 2 years.
For information on a related study, please follow this link:
http://clinicaltrials.gov/show/NCT00149773
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Psychopathology Research Unit-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:
- Recent suicide attempt with an emergency department visit within 48 hours of the attempt (suicide attempt is considered to be a potentially self-injurious behavior with a nonfatal outcome for which there is evidence, either explicit or implicit, that the individual intended to kill himself or herself)
- Current DSM-IV diagnosis of a current drug dependence disorder within the past 6 months
Exclusion Criteria:
- Self-mutilating behavior without intent to commit suicide
- An acute, unstable, or severe Axis III disorder that may affect participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Cognitive Therapy
The cognitive therapy intervention for suicide attempters has been designed to provide a brief, timely, flexible intervention that can be incorporated into general and psychiatric inpatient and outpatient services and applied to the population of patients who attempt suicide.
A central feature of the intervention is the adaptation of cognitive therapy to the population of patients who attempt suicide.
The focus of the intervention is the identification of core beliefs and key automatic thoughts that were elicited prior to and during the most recent suicide attempt.
Once these beliefs and thoughts have been articulated, the counselor and patient develop more adaptive responses during an acute suicidal crisis.
|
The cognitive therapy intervention for suicide attempters has been designed to provide a brief, timely, flexible intervention that can be incorporated into general and psychiatric inpatient and outpatient services and applied to the population of patients who attempt suicide.
A central feature of the intervention is the adaptation of cognitive therapy to the population of patients who attempt suicide.
The focus of the intervention is the identification of core beliefs and key automatic thoughts that were elicited prior to and during the most recent suicide attempt.
Once these beliefs and thoughts have been articulated, the counselor and patient develop more adaptive responses during an acute suicidal crisis.
|
Other: Enriched Care
The Enriched Care condition will be used as the treatment comparison condition for this study.
The Enriched Care condition consists of the usual care that patients may obtain in the community as well as the assessment and referral services provided by the case managers.
Participation in the study does not restrict patients in any way in their access to other health care, and all patients in both conditions will be allowed to receive any additional mental health and substance abuse treatment in the community.
|
The Enriched Care condition will be used as the treatment comparison condition for this study.
The Enriched Care condition consists of the usual care that patients may obtain in the community as well as the assessment and referral services provided by the case managers.
Participation in the study does not restrict patients in any way in their access to other health care, and all patients in both conditions will be allowed to receive any additional mental health and substance abuse treatment in the community.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Suicidal Attempts
Time Frame: Months 1, 3, 6, 12, 18, and 24
|
Months 1, 3, 6, 12, 18, and 24
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Suicide Ideation
Time Frame: Months 1, 3, 6, 12, 18, and 24
|
Months 1, 3, 6, 12, 18, and 24
|
Depression
Time Frame: Months 1, 3, 6, 12, 18, and 24
|
Months 1, 3, 6, 12, 18, and 24
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Hopelessness
Time Frame: Months 1, 3, 6, 12, 18, and 24
|
Months 1, 3, 6, 12, 18, and 24
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Substance Use
Time Frame: Months 1, 3, 6, 12, 18, and 24
|
Months 1, 3, 6, 12, 18, and 24
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- P20MH071905-02 (U.S. NIH Grant/Contract)
- DSIR 83-ATP (NCT00719979)
- 802439 (Other Identifier: University of Pennsylvania IRB)
- FWA00003616
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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