Cognitive Therapy for Suicidal Older Men

Not Applicable

Completed

• Conditions: Suicide, Attempted
• Interventions: Behavioral: Cognitive Therapy; Behavioral: Enhanced Usual Care

• Registration Number: NCT01535482
• Lead Sponsor: University of Pennsylvania

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-08-25
• Study Start: 2011-09
• Study First Submitted QC: 2012-02-14
• Study First Posted: 2012-02-17
• Primary Completion: 2017-04-06
• Study Completion: 2017-04-06
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-07
• Last Update Posted: 2017-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 110

Inclusion Criteria

1. 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.
2. Male
3. 50 years of age or older
4. Able to speak English
5. Able to provide written informed consent
6. Able to attend study assessment and therapy sessions
7. Able to provide at least two verifiable contacts for tracking purposes
8. 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.

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Exclusion Criteria

1. Needed priority treatment for a substance use disorder as determined by the referring clinician.
2. Needed priority treatment for PTSD as determined by the referring clinician.
3. 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Therapy	Cognitive Therapy	A cognitive therapy protocol specifically designed to target suicidal ideation in older adults.
Enhanced Usual Care	Enhanced Usual Care	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.

Primary Outcome Measures

Name	Time	Method
Change in baseline suicidal ideation	baseline, 1, 3, 6, 9, 12 months

Secondary Outcome Measures

Name	Time	Method
reasons for living and dying	baseline, 1, 3, 6, 9, 12 months
perceived social support	baseline, 1, 3, 6, 9, 12 months
Cognitive Executive Functioning	baseline, 1, 3, 6, 9, 12 months	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.
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

Trial Locations

Locations (1)

Aaron T. Beck Psychopathology Research Center - University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States