Cognitive Therapy for Suicidal Older Men
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Suicide, Attempted |
Behavioral: Cognitive Therapy Behavioral: Enhanced Usual Care |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Cognitive Therapy for Suicidal Older Men |
- Change in baseline suicidal ideation [ Time Frame: baseline, 1, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
- depression [ Time Frame: baseline, 1, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
- hopelessness [ Time Frame: baseline, 1, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
- quality of life [ Time Frame: baseline, 1, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
- social problem solving skills [ Time Frame: baseline, 1, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
- complicated grief [ Time Frame: baseline, 1, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
- reasons for living and dying [ Time Frame: baseline, 1, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
- perceived social support [ Time Frame: baseline, 1, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
- Cognitive Executive Functioning [ Time Frame: baseline, 1, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 122 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | May 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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 60 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.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
- 60 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 at baseline as indicated by attendance at an inpatient or outpatient treatment facility for treatment of a substance use disorder (SUD) in the 3 months prior to the baseline assessment. In our preliminary study, no enrolled patients had received treatment for an SUD in the 3 months prior to baseline and all patients were recommended to the study by the referring clinician indicating that priority treatment for SUD was not required.
- Needed priority treatment for PTSD as indicated by initiating treatment for PTSD in the 3 months prior to the baseline assessment and all patients were recommended to the study by the referring clinician indicating that priority treatment for PTSD was not required.
- Taking antidepressant medication for less than three months, or if antidepressant medication has been changed in the last three months as indicated by the Alexopolous "Composite Antidepressant Score" Scale. In our preliminary study, none of the enrolled patients reported psychotropic medication changes in the three months prior to baseline.
Contacts and Locations| Contact: Gregory K Brown, Ph.D. | 215-898-4104 | gregbrow@mail.med.upenn.edu |
| United States, Pennsylvania | |
| Aaron T. Beck Psychopathology Research Center - University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Gregory K Brown, Ph.D. 215-898-4104 gregbrow@mail.med.upenn.edu | |
| Principal Investigator: Gregory K. Brown, Ph.D. | |
More Information
No publications provided
| Responsible Party: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01535482 History of Changes |
| Other Study ID Numbers: | R01MH086572-01A2, 1R01MH086572-01A2 |
| Study First Received: | August 25, 2011 |
| Last Updated: | February 14, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pennsylvania:
|
Cognitive therapy Suicide Older men suicide ideation |
Additional relevant MeSH terms:
|
Suicide Suicide, Attempted Self-Injurious Behavior Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013