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Evaluating a Behavioral Activities Treatment Program for Depressed Nursing Home Residents (BE-ACTIV)

11. april 2017 opdateret af: Suzanne Meeks, University of Louisville

BE-ACTIV: Treating Depression in Nursing Homes

This study will evaluate whether a behavioral activities treatment program improves symptoms of depression in nursing home residents.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Depression is a common mental disorder that affects nearly half of all older people living in nursing homes. Depression can severely impact people's lives, causing them to often feel sad and hopeless, as well as affect people's sleep patterns, concentration, and energy levels. In addition, nursing homes are often understaffed and very busy, making it difficult for older people with depression to receive a proper diagnosis and adequate treatment. Recent studies have shown that an increase in pleasurable activities among residents in nursing homes can improve symptoms of depression. The purpose of this study is to determine whether symptoms of depression can be reduced by increasing opportunities for nursing home residents to engage in pleasant events and build better relationships with nursing home staff members.

Participating nursing homes will be randomly assigned to have their residents receive behavioral activity treatment (BE-ACTIV) or treatment as usual for 12 weeks. Potential participating nursing home residents will complete two brief tests regarding memory, attention, and symptoms of depression. An hour-long interview will then be conducted during which eligible participating residents will discuss their symptoms of depression, rate their health and level of functioning, and assess the quality of their relationship with a staff member. Residents receiving BE-ACTIV will meet with a therapist for weekly 30-minute sessions for 10 weeks. During these sessions, residents will discuss their activity participation and any pleasant events that they recently experienced. Therapists and nursing home activities staff will work together to incorporate more activities of interest into each resident's schedule. Residents of nursing homes assigned to receive treatment as usual will be asked to rate their mood once a week for 10 weeks. Researchers will observe each resident, regardless of treatment group, for 5-minute intervals at various times during the study to assess mood and activity levels. All participating residents will undergo a second interview after 10 weeks to discuss any changes or improvements in mood, symptoms of depression, activity level, or their relationship with staff members. All participating residents will be assessed after 3 months and again after 6 months post-treatment to determine whether the BE-ACTIV program was successful in improving symptoms of depression.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40292
        • University of Louisville

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Nursing home residents in long-term care beds with an expected stay of 3 months or more
  • Geriatric Depression Scale score of at least 11
  • Meets DSM-IV criteria for major depressive disorder or research diagnostic criteria for minor depressive disorder

Exclusion Criteria:

  • Mini Mental State Exam score below 14
  • Referred to hospice care for a terminal condition
  • Current unstable or terminal medical condition
  • Suicidal
  • Meets DSM-IV criteria for bipolar disorder

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: A
Participants will receive the BE-ACTIV treatment
BE-ACTIV is 10-week behavioral treatment involving increasing pleasant events.
Aktiv komparator: B
Participants will receive treatment as usual
TAU includes usual treatment in nursing care facility.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Depression diagnosis and depressive symptoms as assessed by the Geriatric Depression Scale
Tidsramme: Measured at Weeks 12, 24, and 48
Measured at Weeks 12, 24, and 48
Functioning as assessed by the Dartmouth COOP Scales for Social Functioning
Tidsramme: Measured at Weeks 12, 24, and 48
Measured at Weeks 12, 24, and 48

Sekundære resultatmål

Resultatmål
Tidsramme
Staff attention
Tidsramme: Measured at Weeks 12, 24, and 48
Measured at Weeks 12, 24, and 48
Positive affect
Tidsramme: Measured at Weeks 12, 24, and 48
Measured at Weeks 12, 24, and 48
Activity participation
Tidsramme: Measured at Weeks 12, 24, and 48
Measured at Weeks 12, 24, and 48
Behavior problems
Tidsramme: Measured at Weeks 12, 24, and 48
Measured at Weeks 12, 24, and 48
Resident satisfaction
Tidsramme: Measured at Weeks 12, 24, and 48
Measured at Weeks 12, 24, and 48

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Suzanne Meeks, PhD, University of Louisville

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2007

Primær færdiggørelse (Faktiske)

1. juli 2013

Studieafslutning (Faktiske)

1. november 2013

Datoer for studieregistrering

Først indsendt

25. september 2007

Først indsendt, der opfyldte QC-kriterier

25. september 2007

Først opslået (Skøn)

27. september 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R01MH074865 (U.S. NIH-bevilling/kontrakt)
  • DATR A4-GPS

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Depression

Kliniske forsøg med BE-ACTIV

3
Abonner