Cognitive Therapy for Suicidal Older Men in Primary Care Settings
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.
|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 Suicidal Older Men in Primary Care Settings|
- Suicidal Ideation; measured at Months 1, 3, 6, 12, 18, and 24 [ Time Frame: 1, 3, 6, 12, 18, and 24 months ] [ Designated as safety issue: Yes ]
- Depression; measured at Months 1, 3, 6, 12, 18, and 24 [ Time Frame: 1, 3, 6, 12, 18, and 24 months ] [ Designated as safety issue: Yes ]
- Hopelessness; measured at Months 1, 3, 6, 12, 18, and 24 [ Time Frame: 1, 3, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
- Perceived Social Support; measured at Months 1, 3, 6, 12, 18, and 24 [ Time Frame: 1, 3, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2005|
|Study Completion Date:||February 2011|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Experimental: Cognitive Therapy + Enriched Usual Care
The cognitive therapy intervention consists of approximately 12 (1-hour) sessions over the course of a 4-month period. The main therapy components include:
|Behavioral: Cognitive Therapy|
No Intervention: EnrichedUsual Care Condition
The Enriched Care (EC) condition will be used as the treatment comparison for this study. EC consists of usual care patients may obtain in the community as well as the assessment and referral services provided by the study 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 treatment in the community.
The primary role of the study case manager is to establish a strong relationship with patients in order to retain the patients in the study for the duration of the study period.
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00149773
|United States, Pennsylvania|
|Psychopathology Research Unit - University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Aaron T. Beck, MD||University of Pennsylvania|
|Principal Investigator:||Gregory K. Brown, PhD||University of Pennsylvania|