Cognitive Therapy for Suicidal Older Men
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19104
- Aaron T. Beck Psychopathology Research Center - University of Pennsylvania
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Cognitive Therapy
A cognitive therapy protocol specifically designed to target suicidal ideation in older adults.
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Cognitive therapy (CT) will consist of 12 to 16 individual CT sessions on a weekly basis plus 3 booster sessions.
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Aktivní komparátor: 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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Change in baseline suicidal ideation
Časové okno: baseline, 1, 3, 6, 9, 12 months
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baseline, 1, 3, 6, 9, 12 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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depression
Časové okno: baseline, 1, 3, 6, 9, 12 months
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baseline, 1, 3, 6, 9, 12 months
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hopelessness
Časové okno: baseline, 1, 3, 6, 9, 12 months
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baseline, 1, 3, 6, 9, 12 months
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quality of life
Časové okno: baseline, 1, 3, 6, 9, 12 months
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baseline, 1, 3, 6, 9, 12 months
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social problem solving skills
Časové okno: baseline, 1, 3, 6, 9, 12 months
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baseline, 1, 3, 6, 9, 12 months
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complicated grief
Časové okno: baseline, 1, 3, 6, 9, 12 months
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baseline, 1, 3, 6, 9, 12 months
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reasons for living and dying
Časové okno: baseline, 1, 3, 6, 9, 12 months
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baseline, 1, 3, 6, 9, 12 months
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perceived social support
Časové okno: baseline, 1, 3, 6, 9, 12 months
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baseline, 1, 3, 6, 9, 12 months
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Cognitive Executive Functioning
Časové okno: baseline, 1, 3, 6, 9, 12 months
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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.
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baseline, 1, 3, 6, 9, 12 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- R01MH086572-01A2 (Grant/smlouva NIH USA)
- 1R01MH086572-01A2 (Grant/smlouva NIH USA)
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