Cognitive Therapy for Suicidal Older Men in Primary Care Settings - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 6, 2005

Last Updated Date

January 29, 2008

Start Date ^†

May 2005

Current Primary Outcome Measures ^†

Suicidal Ideation; measured at Months 1, 3, 6, 12, 18, and 24

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00149773 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Depression; measured at Months 1, 3, 6, 12, 18, and 24
Hopelessness; measured at Months 1, 3, 6, 12, 18, and 24
Perceived Social Support; measured at Months 1, 3, 6, 12, 18, and 24

Original Secondary Outcome Measures ^†

Depression; measured at Months 1, 3, 6, 12, 18, and 24
Hopelessness; measured at Months 1, 3, 6, 12, 18, and 24
Perceived Social Support; measured at Months 1, 3, 6, 12, 18, and 24

Descriptive Information

Brief Title ^†

Cognitive Therapy for Suicidal Older Men in Primary Care Settings

Official Title ^†

Cognitive Therapy for Suicidal Older Men in Primary Care Settings

Brief Summary

This study will assess the effectiveness of cognitive therapy in reducing the incidence of suicide ideation and behavior in older men in a primary care setting.

Detailed Description

Older adult males have the highest suicide rate of any age group in the U.S. Over 70 percent of older suicide victims have been to their primary care physician within a month of their death, many with a depressive illness that was not detected. However, most research concerning treatments for suicide ideation and behavior has focused on adolescents and young adults. Very few treatments have been developed to reduce suicide ideation and behavior in men aged 60 and above. This study will assess the effectiveness of specialized cognitive therapy versus typical treatment in treating older men with suicide ideation.

Participants in this two-year, single-blind study will be randomly assigned to receive either cognitive therapy combined with enriched care or enriched care alone. Participants will be identified in primary care settings as having experienced suicide ideation in the past month. Cognitive therapy will be provided by Ph.D.-level therapists and will be geared specifically toward older men with suicidal tendencies. The enriched care condition will consist of the usual care that individuals receive for suicide prevention, plus assessment and referral services provided by independent evaluators and study case managers. All participants will be assessed pre-treatment to attain baseline measures of suicide ideation, hopelessness, and depression. Study visits will occur at baseline and Months 1, 3, 6, 12, 18, and 24 to assess suicide ideation. Self-report and clinician-administered measures will be used to assess participants' progress.

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Suicide, Attempted

Intervention ^†

Behavioral: Cognitive Therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Currently experiencing death ideation or suicidal ideation (total score greater than 0 on the Scale for Suicide Ideation)
English-speaking
Lives within the area served by the research unit
Able to provide at least 2 verifiable contacts (typically family members)

Exclusion Criteria:

Requires priority treatment for an acute, unstable, or severe Axis III disorder (e.g., dementia)
Requires priority treatment for another debilitating problem (e.g., severe alcohol or drug dependence, mania, severe anorexia)
Suffers from a psychotic disorder or psychotic thought processes
Exhibits self-mutilating behavior without any intent to commit suicide (e.g., burning oneself with a cigarette)

Gender

Male

Ages

60 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Gregory K. Brown, PhD

215-898-4104

gregbrow@mail.med.upenn.edu

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00149773

Responsible Party

Secondary IDs ^††

802223, DSIR 83-ATP

Study Sponsor ^†

National Institute of Mental Health (NIMH)

Collaborators ^††

Investigators ^†

Principal Investigator:	Aaron T. Beck, MD	University of Pennsylvania
Principal Investigator:	Gregory K. Brown, PhD	University of Pennsylvania

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

June 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.