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Cognitive Therapy for Suicidal Older Men

7. juni 2017 oppdatert av: University of Pennsylvania
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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

110

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Aaron T. Beck Psychopathology Research Center - University of Pennsylvania

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

50 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

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.

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Cognitive Therapy
A cognitive therapy protocol specifically designed to target suicidal ideation in older adults.
Atferdsmessig: Cognitive Therapy
Cognitive therapy (CT) will consist of 12 to 16 individual CT sessions on a weekly basis plus 3 booster sessions.
Aktiv komparator: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Change in baseline suicidal ideation
Tidsramme: baseline, 1, 3, 6, 9, 12 months
baseline, 1, 3, 6, 9, 12 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
depression
Tidsramme: baseline, 1, 3, 6, 9, 12 months
baseline, 1, 3, 6, 9, 12 months
hopelessness
Tidsramme: baseline, 1, 3, 6, 9, 12 months
baseline, 1, 3, 6, 9, 12 months
quality of life
Tidsramme: baseline, 1, 3, 6, 9, 12 months
baseline, 1, 3, 6, 9, 12 months
social problem solving skills
Tidsramme: baseline, 1, 3, 6, 9, 12 months
baseline, 1, 3, 6, 9, 12 months
complicated grief
Tidsramme: baseline, 1, 3, 6, 9, 12 months
baseline, 1, 3, 6, 9, 12 months
reasons for living and dying
Tidsramme: baseline, 1, 3, 6, 9, 12 months
baseline, 1, 3, 6, 9, 12 months
perceived social support
Tidsramme: baseline, 1, 3, 6, 9, 12 months
baseline, 1, 3, 6, 9, 12 months
Cognitive Executive Functioning
Tidsramme: 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.
baseline, 1, 3, 6, 9, 12 months

Samarbeidspartnere og etterforskere

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Sponsor

University of Pennsylvania

Samarbeidspartnere

National Institute of Mental Health (NIMH)

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2011

Primær fullføring (Faktiske)

6. april 2017

Studiet fullført (Faktiske)

6. april 2017

Datoer for studieregistrering

Først innsendt

25. august 2011

Først innsendt som oppfylte QC-kriteriene

14. februar 2012

Først lagt ut (Anslag)

17. februar 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. juni 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. juni 2017

Sist bekreftet

1. juni 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • R01MH086572-01A2 (U.S. NIH-stipend/kontrakt)
  • 1R01MH086572-01A2 (U.S. NIH-stipend/kontrakt)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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