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Clinical Trials/NCT01535482
NCT01535482
Completed
Not Applicable

Cognitive Therapy for Suicidal Older Men

University of Pennsylvania1 site in 1 country110 target enrollmentSeptember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Suicide, Attempted
Sponsor
University of Pennsylvania
Enrollment
110
Locations
1
Primary Endpoint
Change in baseline suicidal ideation
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The primary aim of the proposed study is to compare the efficacy of cognitive therapy (CT) with the efficacy of an enhanced usual care (EUC) intervention for reducing the rate of suicide ideation (SI) and the severity of depression and hopelessness among older men. The investigators expect that suicidal older men randomly assigned to the CT intervention condition will have a lower rate of SI during the follow-up period than participants assigned to the control condition.

Detailed Description

Older adult males have the highest suicide rate of any age group in the U.S. 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 50 and above. This study will assess the effectiveness of specialized cognitive therapy versus enhanced usual care in treating older men with suicide ideation. Participants in this five-year study will be randomly assigned to receive either cognitive therapy or enhanced usual care. Participants will be identified within the VA Medical Center and the University of Pennsylvania Health System (UPHS) 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 enhanced usual 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. In addition, patients in the enhanced usual care condition will receive weekly telephone calls from the study therapists. These phone calls will be approximately 15-30 minutes in duration and their purpose will be to ensure patient safety and to provide some support. 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, 9, and 12 to assess suicide ideation. Self-report and clinician-administered measures will be used to assess participants' progress.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
April 6, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Suicidal intent or desire during the past month prior to the baseline interview as indicated by a score of 1 or higher on items 4 or 5 of the Scale for Suicide Ideation.
  • 50 years of age or older
  • Able to speak English
  • Able to provide written informed consent
  • Able to attend study assessment and therapy sessions
  • Able to provide at least two verifiable contacts for tracking purposes
  • Able to function at an intellectual level to allow for the reliable completion of study assessments and participate in psychotherapy as indicated by a Mini-Mental Status Exam (MMSE) total score of 24 or higher and an Executive Interview (EXIT-25) total score of 14 or lower.

Exclusion Criteria

  • Needed priority treatment for a substance use disorder as determined by the referring clinician.
  • Needed priority treatment for PTSD as determined by the referring clinician.
  • Taking antidepressant medication for less than one month, or if antidepressant medication has been changed in the last month as indicated by the Alexopolous "Composite Antidepressant Score" Scale.

Outcomes

Primary Outcomes

Change in baseline suicidal ideation

Time Frame: baseline, 1, 3, 6, 9, 12 months

Secondary Outcomes

  • Cognitive Executive Functioning(baseline, 1, 3, 6, 9, 12 months)
  • reasons for living and dying(baseline, 1, 3, 6, 9, 12 months)
  • perceived social support(baseline, 1, 3, 6, 9, 12 months)
  • complicated grief(baseline, 1, 3, 6, 9, 12 months)
  • hopelessness(baseline, 1, 3, 6, 9, 12 months)
  • depression(baseline, 1, 3, 6, 9, 12 months)
  • social problem solving skills(baseline, 1, 3, 6, 9, 12 months)
  • quality of life(baseline, 1, 3, 6, 9, 12 months)

Study Sites (1)

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