Cognitive Therapy for Suicidal Older Men
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|ClinicalTrials.gov Identifier: NCT01535482|
Recruitment Status : Completed
First Posted : February 17, 2012
Last Update Posted : June 8, 2017
|Condition or disease||Intervention/treatment|
|Suicide, Attempted||Behavioral: Cognitive Therapy Behavioral: Enhanced Usual Care|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Cognitive Therapy for Suicidal Older Men|
|Study Start Date :||September 2011|
|Primary Completion Date :||April 6, 2017|
|Study Completion Date :||April 6, 2017|
Experimental: Cognitive Therapy
A cognitive therapy protocol specifically designed to target suicidal ideation in older adults.
Behavioral: Cognitive Therapy
Cognitive therapy (CT) will consist of 12 to 16 individual CT sessions on a weekly basis plus 3 booster sessions.
Active Comparator: 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.
Behavioral: Enhanced Usual Care
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.
- Change in baseline suicidal ideation [ Time Frame: baseline, 1, 3, 6, 9, 12 months ]
- depression [ Time Frame: baseline, 1, 3, 6, 9, 12 months ]
- hopelessness [ Time Frame: baseline, 1, 3, 6, 9, 12 months ]
- quality of life [ Time Frame: baseline, 1, 3, 6, 9, 12 months ]
- social problem solving skills [ Time Frame: baseline, 1, 3, 6, 9, 12 months ]
- complicated grief [ Time Frame: baseline, 1, 3, 6, 9, 12 months ]
- reasons for living and dying [ Time Frame: baseline, 1, 3, 6, 9, 12 months ]
- perceived social support [ Time Frame: baseline, 1, 3, 6, 9, 12 months ]
- Cognitive Executive Functioning [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01535482
|United States, Pennsylvania|
|Aaron T. Beck Psychopathology Research Center - University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|