Cognitive Therapy for Suicidal Older Men in Primary Care Settings

Suicide, Attempted Clinical Trial

Official title:

Cognitive Therapy for Suicidal Older Men in Primary Care Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149773
• Other study ID #: P20MH071905-01
• Secondary ID: P20MH071905-0180
• Status: Completed
• Phase: Phase 1
• First received: September 6, 2005
• Last updated: April 6, 2015
• Start date: May 2005
• Est. completion date: February 2011

Study information

• Verified date: June 2006
• 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 assess the effectiveness of cognitive therapy in reducing the incidence of suicide ideation and behavior in older men in a primary care setting.

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.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00218725

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2011
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 60 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Suicide, Attempted

Intervention

Behavioral:
• Cognitive Therapy

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 Ideation; measured at Months 1, 3, 6, 12, 18, and 24		1, 3, 6, 12, 18, and 24 months	Yes
Secondary	Depression; measured at Months 1, 3, 6, 12, 18, and 24		1, 3, 6, 12, 18, and 24 months	Yes
Secondary	Hopelessness; measured at Months 1, 3, 6, 12, 18, and 24		1, 3, 6, 12, 18, and 24 months	No
Secondary	Perceived Social Support; measured at Months 1, 3, 6, 12, 18, and 24		1, 3, 6, 12, 18, and 24 months	No