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Cognitive Therapy for Suicidal Older Men

7 juni 2017 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

110

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19104
        • Aaron T. Beck Psychopathology Research Center - University of Pennsylvania

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

50 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Manlig

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Cognitive Therapy
A cognitive therapy protocol specifically designed to target suicidal ideation in older adults.
Beteende: 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.
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Change in baseline suicidal ideation
Tidsram: baseline, 1, 3, 6, 9, 12 months
baseline, 1, 3, 6, 9, 12 months

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Pennsylvania

Samarbetspartners

National Institute of Mental Health (NIMH)

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2011

Primärt slutförande (Faktisk)

6 april 2017

Avslutad studie (Faktisk)

6 april 2017

Studieregistreringsdatum

Först inskickad

25 augusti 2011

Först inskickad som uppfyllde QC-kriterierna

14 februari 2012

Första postat (Uppskatta)

17 februari 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 juni 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 juni 2017

Senast verifierad

1 juni 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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