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Cognitive Therapy for Suicidal Older Men in Primary Care Settings

Primary Purpose

Suicide, Attempted

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cognitive Therapy
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide, Attempted focused on measuring Cognitive therapy, Suicide, Older men, Death ideation, Primary care

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Psychopathology Research Unit - University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive Therapy + Enriched Usual Care

EnrichedUsual Care Condition

Arm Description

The cognitive therapy intervention consists of approximately 12 (1-hour) sessions over the course of a 4-month period. The main therapy components include: 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. Improving social resources. Improving adherence to medical regimen. Targeting Suicidal Cognitions.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 6, 2005
Last Updated
April 6, 2015
Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00149773
Brief Title
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

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted
Keywords
Cognitive therapy, Suicide, Older men, Death ideation, Primary care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Therapy + Enriched Usual Care
Arm Type
Experimental
Arm Description
The cognitive therapy intervention consists of approximately 12 (1-hour) sessions over the course of a 4-month period. The main therapy components include: 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. Improving social resources. Improving adherence to medical regimen. Targeting Suicidal Cognitions.
Arm Title
EnrichedUsual Care Condition
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Therapy
Primary Outcome Measure Information:
Title
Suicidal Ideation; measured at Months 1, 3, 6, 12, 18, and 24
Time Frame
1, 3, 6, 12, 18, and 24 months
Secondary Outcome Measure Information:
Title
Depression; measured at Months 1, 3, 6, 12, 18, and 24
Time Frame
1, 3, 6, 12, 18, and 24 months
Title
Hopelessness; measured at Months 1, 3, 6, 12, 18, and 24
Time Frame
1, 3, 6, 12, 18, and 24 months
Title
Perceived Social Support; measured at Months 1, 3, 6, 12, 18, and 24
Time Frame
1, 3, 6, 12, 18, and 24 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron T. Beck, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gregory K. Brown, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychopathology Research Unit - University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Cognitive Therapy for Suicidal Older Men in Primary Care Settings

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