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Completed

NCT Number: NCT00149773

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.

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Key information

Age range

60 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Psychopathology Research Unit - University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

cognitive therapy

Behavioral

Primary outcomes

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

    Time frame: 1, 3, 6, 12, 18, and 24 months

Secondary outcomes

  1. Depression; measured at Months 1, 3, 6, 12, 18, and 24

    Time frame: 1, 3, 6, 12, 18, and 24 months

  2. Hopelessness; measured at Months 1, 3, 6, 12, 18, and 24

    Time frame: 1, 3, 6, 12, 18, and 24 months

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

    Time frame: 1, 3, 6, 12, 18, and 24 months

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2011
First posted
Sep 8, 2005
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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