Cognitive Therapy for Suicidal Older Men
Primary Purpose
Suicide, Attempted
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Therapy
Enhanced Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Suicide, Attempted focused on measuring Cognitive therapy, Suicide, Older men, suicide ideation
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.
- Male
- 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.
Sites / Locations
- Aaron T. Beck Psychopathology Research Center - University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive Therapy
Enhanced Usual Care
Arm Description
A cognitive therapy protocol specifically designed to target suicidal ideation in older adults.
Enhanced usual care consists of the usual care that individuals receive for suicide prevention, plus assessment and referral services provided by project staff, and weekly phone calls provided by study therapists.
Outcomes
Primary Outcome Measures
Change in baseline suicidal ideation
Secondary Outcome Measures
depression
hopelessness
quality of life
social problem solving skills
complicated grief
reasons for living and dying
perceived social support
Cognitive Executive Functioning
Executive functioning will be measured by scores on an Executive Functioning Interview, which measures skills such as planning, working memory, attention, inhibition, and mental flexibility.
Full Information
NCT ID
NCT01535482
First Posted
August 25, 2011
Last Updated
June 7, 2017
Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01535482
Brief Title
Cognitive Therapy for Suicidal Older Men
Official Title
Cognitive Therapy for Suicidal Older Men
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 6, 2017 (Actual)
Study Completion Date
April 6, 2017 (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
Data Monitoring Committee
Yes
5. Study Description
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.
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, suicide ideation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Therapy
Arm Type
Experimental
Arm Description
A cognitive therapy protocol specifically designed to target suicidal ideation in older adults.
Arm Title
Enhanced Usual Care
Arm Type
Active Comparator
Arm Description
Enhanced usual care consists of the usual care that individuals receive for suicide prevention, plus assessment and referral services provided by project staff, and weekly phone calls provided by study therapists.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Therapy
Intervention Description
Cognitive therapy (CT) will consist of 12 to 16 individual CT sessions on a weekly basis plus 3 booster sessions.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care
Intervention Description
Enhanced usual care (EUC) will consist of the usual care that individuals receive for suicide prevention in the community, assessment and referral services provided by study staff, and weekly telephone calls lasting 15-30 minutes provided by study therapists to ensure patient safety and to provide some support.
Primary Outcome Measure Information:
Title
Change in baseline suicidal ideation
Time Frame
baseline, 1, 3, 6, 9, 12 months
Secondary Outcome Measure Information:
Title
depression
Time Frame
baseline, 1, 3, 6, 9, 12 months
Title
hopelessness
Time Frame
baseline, 1, 3, 6, 9, 12 months
Title
quality of life
Time Frame
baseline, 1, 3, 6, 9, 12 months
Title
social problem solving skills
Time Frame
baseline, 1, 3, 6, 9, 12 months
Title
complicated grief
Time Frame
baseline, 1, 3, 6, 9, 12 months
Title
reasons for living and dying
Time Frame
baseline, 1, 3, 6, 9, 12 months
Title
perceived social support
Time Frame
baseline, 1, 3, 6, 9, 12 months
Title
Cognitive Executive Functioning
Description
Executive functioning will be measured by scores on an Executive Functioning Interview, which measures skills such as planning, working memory, attention, inhibition, and mental flexibility.
Time Frame
baseline, 1, 3, 6, 9, 12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Male
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.
Facility Information:
Facility Name
Aaron T. Beck Psychopathology Research Center - University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
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Cognitive Therapy for Suicidal Older Men
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