Cognitive Therapy for Suicidal Older Men in Primary Care Settings

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00149773
First received: September 6, 2005
Last updated: April 6, 2015
Last verified: June 2006

September 6, 2005
April 6, 2015
May 2005
December 2008   (final data collection date for primary outcome measure)
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 ]
Suicidal Ideation; measured at Months 1, 3, 6, 12, 18, and 24
Complete list of historical versions of study NCT00149773 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
Cognitive Therapy for Suicidal Older Men in Primary Care Settings
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.

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Suicide, Attempted
Behavioral: Cognitive Therapy
  • 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:

    1. Using problem-solving and cognitive restructuring techniques to target hopelessness, reasons for living and dying, coping with loss, and perceived medical comorbidity that lead to suicidal ideation.
    2. Improving social resources.
    3. Improving adherence to medical regimen.
    4. Targeting Suicidal Cognitions.
    Intervention: 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.

Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
February 2011
December 2008   (final data collection date for primary outcome measure)

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)
Male
60 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00149773
P20MH071905-01, P20MH071905-01, 802223, DSIR 83-ATP
Not Provided
Not Provided
Not Provided
University of Pennsylvania
University of Pennsylvania
National Institute of Mental Health (NIMH)
Principal Investigator: Aaron T. Beck, MD University of Pennsylvania
Principal Investigator: Gregory K. Brown, PhD University of Pennsylvania
University of Pennsylvania
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP