Clinical trial NCT00218725: Effectiveness of Cognitive Therapy for Suicide Attempters With Drug Dependence Disorder
Official title: Cognitive Therapy for Suicide Attempters With Drug Dependence Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Suicide, Attempted
Substance-Related Disorders
Keywords: Cognitive Therapy
Suicide
Addictions
Substance Abuse
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-22
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Suicidal Attempts
timeFrame: Months 1, 3, 6, 12, 18, and 24
Secondary outcomes:
measure: Suicide Ideation
timeFrame: Months 1, 3, 6, 12, 18, and 24
measure: Depression
timeFrame: Months 1, 3, 6, 12, 18, and 24
measure: Hopelessness
timeFrame: Months 1, 3, 6, 12, 18, and 24
measure: Substance Use
timeFrame: Months 1, 3, 6, 12, 18, and 24
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Psychopathology Research Unit-University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Aaron T. Beck, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Gregory K. Brown, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.