Effectiveness of Cognitive Therapy for Suicide Attempters With Drug Dependence Disorder

Substance-Related Disorders Clinical Trial

Official title:

Cognitive Therapy for Suicide Attempters With Drug Dependence Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218725
• Other study ID #: P20MH071905-02
• Secondary ID: P20MH071905-0280
• Status: Completed
• Phase: Phase 1
• First received: September 21, 2005
• Last updated: September 28, 2015
• Start date: May 2005
• Est. completion date: October 2005

Study information

• Verified date: September 2015
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Substance-Related Disorders
• Suicide
• Suicide, Attempted

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Psychopathology Research Unit-University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suicidal Attempts		Months 1, 3, 6, 12, 18, and 24	Yes
Secondary	Suicide Ideation		Months 1, 3, 6, 12, 18, and 24	Yes
Secondary	Depression		Months 1, 3, 6, 12, 18, and 24	Yes
Secondary	Hopelessness		Months 1, 3, 6, 12, 18, and 24	Yes
Secondary	Substance Use		Months 1, 3, 6, 12, 18, and 24	Yes