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CompletedNCT00149773Updated Apr 8, 2015

Cognitive Therapy for Suicidal Older Men in Primary Care Settings

A Phase 1 interventional study of Cognitive Therapy in Suicide, Attempted, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to male participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2015-04-08.

Sponsored by University of Pennsylvania · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
60 Years and older
Sex
Male
01

Study 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.

Read the 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

02

Conditions studied

  • Suicide, Attempted

Keywords

  • Cognitive therapy
  • Suicide
  • Older men
  • Death ideation
  • Primary care
03

In context

Suicide

701 studies on the registry are indexed under Suicide; 183 are open to participants now.

This study's enrollment of 34 is below the median of 104 across 560 interventional studies indexed under Suicide.

Browse Suicide studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • 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.

    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.

Interventions

  • BehavioralCognitive Therapy
06

What researchers measure

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

07

Study locations

1 site
  • Psychopathology Research Unit - University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00149773
Lead sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Sep 8, 2005
Start date
May 2005
Primary completion
Dec 2008
Completion
Feb 2011
Last update
Apr 8, 2015

Study contacts

Aaron T. Beck, MD
principal investigator · University of Pennsylvania
Gregory K. Brown, PhD
principal investigator · University of Pennsylvania
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2006. You cannot join it, but the record below documents what was studied.

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