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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00218725 |
Purpose
This study will examine the effectiveness of combining cognitive therapy with enriched usual care for preventing subsequent suicide attempts in people with a drug dependence who have recently attempted suicide.
| Condition | Intervention | Phase |
|---|---|---|
|
Suicide, Attempted Substance-Related Disorders |
Behavioral: Cognitive Therapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Cognitive Therapy for Suicide Attempters With Drug Dependence Disorder |
| Estimated Enrollment: | 48 |
| Study Start Date: | May 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| Psychopathology Research Unit-University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Aaron T. Beck, MD | University of Pennsylvania |
| Principal Investigator: | Gregory K. Brown, PhD | University of Pennsylvania |
More Information
| Study ID Numbers: | P20 MH071905-02, 802439, FWA00003616, DSIR 83-ATP |
| Study First Received: | September 21, 2005 |
| Last Updated: | February 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00218725 History of Changes |
| Health Authority: | United States: Federal Government |
|
Cognitive Therapy Suicide Addictions Substance Abuse |
|
Pathologic Processes Suicide, Attempted Disease Mental Disorders Substance-Related Disorders |
Disorders of Environmental Origin Suicide Behavioral Symptoms Self-Injurious Behavior |