Effectiveness of Cognitive Therapy for Suicide Attempters With Drug Dependence Disorder

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00218725
First received: September 21, 2005
Last updated: September 28, 2015
Last verified: September 2015
  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
Other: Enriched Care
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Therapy for Suicide Attempters With Drug Dependence Disorder

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Suicidal Attempts [ Time Frame: Months 1, 3, 6, 12, 18, and 24 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Suicide Ideation [ Time Frame: Months 1, 3, 6, 12, 18, and 24 ] [ Designated as safety issue: Yes ]
  • Depression [ Time Frame: Months 1, 3, 6, 12, 18, and 24 ] [ Designated as safety issue: Yes ]
  • Hopelessness [ Time Frame: Months 1, 3, 6, 12, 18, and 24 ] [ Designated as safety issue: Yes ]
  • Substance Use [ Time Frame: Months 1, 3, 6, 12, 18, and 24 ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: May 2005
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: 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.
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.
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.
Other Name: Case Management

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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218725

Locations
United States, Pennsylvania
Psychopathology Research Unit-University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Aaron T. Beck, MD University of Pennsylvania
Principal Investigator: Gregory K. Brown, PhD University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00218725     History of Changes
Other Study ID Numbers: P20MH071905-02  802439  FWA00003616  DSIR 83-ATP 
Study First Received: September 21, 2005
Last Updated: September 28, 2015
Health Authority: United States: Federal Government

Keywords provided by University of Pennsylvania:
Cognitive Therapy
Suicide
Addictions
Substance Abuse

Additional relevant MeSH terms:
Disease
Suicide
Substance-Related Disorders
Suicide, Attempted
Pathologic Processes
Self-Injurious Behavior
Behavioral Symptoms
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 25, 2016