Clinical trial NCT00149773: Cognitive Therapy for Suicidal Older Men in Primary Care Settings
Official title: Cognitive Therapy for Suicidal Older Men in Primary Care Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Suicide, Attempted
Keywords: Cognitive therapy
Suicide
Older men
Death ideation
Primary care
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-08
Enrollment: 34
Sex: MALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

http://clinicaltrials.gov/show/NCT00218725

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)

Primary outcomes:
measure: Suicidal Ideation; measured at Months 1, 3, 6, 12, 18, and 24
timeFrame: 1, 3, 6, 12, 18, and 24 months
Secondary outcomes:
measure: Depression; measured at Months 1, 3, 6, 12, 18, and 24
timeFrame: 1, 3, 6, 12, 18, and 24 months
measure: Hopelessness; measured at Months 1, 3, 6, 12, 18, and 24
timeFrame: 1, 3, 6, 12, 18, and 24 months
measure: Perceived Social Support; measured at Months 1, 3, 6, 12, 18, and 24
timeFrame: 1, 3, 6, 12, 18, and 24 months
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: