Aaron T. Beck Psychopathology Research Center - University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT01535482
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.
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Notify Me50 year and older
Male
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cognitive therapy (CT) will consist of 12 to 16 individual CT sessions on a weekly basis plus 3 booster sessions.
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.
Time frame: baseline, 1, 3, 6, 9, 12 months
Time frame: baseline, 1, 3, 6, 9, 12 months
Time frame: baseline, 1, 3, 6, 9, 12 months
Time frame: baseline, 1, 3, 6, 9, 12 months
Time frame: baseline, 1, 3, 6, 9, 12 months
Time frame: baseline, 1, 3, 6, 9, 12 months
Time frame: baseline, 1, 3, 6, 9, 12 months
Time frame: baseline, 1, 3, 6, 9, 12 months
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.
University of Pennsylvania
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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