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Comparing Engage to PST for Late Life Depression (Engage)

25. juni 2021 oppdatert av: Pat Arean, University of Washington

Stepped, Reward-exposure Based Therapy vs. PST in Late Life Depression

This is a non-inferiority trial of Engage, a new intervention for late-life depression, and problem solving therapy (PST). Patient participants will be randomized to either Engage or PST and receive 9 weeks of either intervention. Interview assessments will be collected at baseline and weeks 2, 4, 6, 8, 9, 26, and 36. Clinician participants, social workers from mental health agencies, will be randomized to receive training and certification in either Engage or PST.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

Policy reports document that evidence-based psychotherapies are rarely employed and sustained in the community. Several causes of this science to service gap have been identified. One cause, specific to behavioral interventions, is the complexity of interventions and the competencies community clinicians must acquire and sustain over time in order to deliver them. A realistic solution is to streamline behavioral interventions and tailor them to the settings and therapist skill level available in the community. In response to this need, we have developed Engage, which: 1) is streamlined on the basis of concepts and findings on the neurobiology of depression; 2) consists of psychotherapeutic and ecosystem management components of known efficacy; 3) has distilled and simplified these components so as they can be accessible to most depressed older patients and taught to larger numbers of clinicians than available therapies, e.g., Problem Solving Therapy (PST); and 4) is personalized through a structured stepped approach focusing on "reward exposure". Problem Solving Therapy is an evidenced-based intervention shown to be effective in treating late-life depression.

Three hundred (150 per site) patient participants will be randomly assigned to receive 9 sessions of either Engage or PST. Forty-two clinician participants will be randomly assigned to receive training and certification in either Engage or PST. Once certified, clinicians will be assigned a patient participant and administer their assigned intervention.

Studietype

Intervensjonell

Registrering (Faktiske)

262

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

    • New York
      • White Plains, New York, Forente stater, 10605
        • Weill Medical College of Cornell University
    • Washington
      • Seattle, Washington, Forente stater, 98195
        • University of Washington Department of Psychiatry and Behavioral Sciences

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

60 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria (Patient participants):

  • Age ≥ 60 years
  • unipolar, non-psychotic major depression (by SCID, DSM-IV)
  • MADRS ≥ 20
  • MMSE ≥ 24
  • off antidepressants or have been on a stable dose of an antidepressant for 12 weeks and do not intend to change the dose in the next 10 weeks
  • English speaking
  • capacity to provide written consent

Exclusion Criteria (Patient participants):

  • Presence of psychiatric diagnoses other than unipolar, non-psychotic major depression or generalized anxiety disorder
  • Newly started use of psychotropic drugs (<12wks) or cholinesterase inhibitors other than mild doses of benzodiazepines
  • Current active suicidal intent/plan
  • Current substance abuse

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: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Problem Solving Therapy
Problem solving therapy is an evidence based psychotherapy for depression, with 30 years of research supporting its efficacy. PST focuses on the patients themselves and helps them develop skills in identifying, prioritizing, and solving problems, and thereby creates a sense of empowerment.
PST is a behavioral intervention for depression that is delivered by trained therapists over a 9 week period. It consists of a process to help patients understand and then solve the problems in their lives they feel is contributing to their depression.
Eksperimentell: Engage
Engage utilizes reward exposure consisting of the reintroduction of activities that patients once found rewarding and enjoyed, but have abandoned after they developed depression. Engage uses basic problem solving through which patients learn how to form "action plans" for pursuing rewarding activities of their choice.
Engage is a weekly behavioral intervention that is delivered over a 9 week period of time by trained therapists. The focus of Engage is to help patient reconnect with activities that they have lost interest in pursuing due to depression.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Depression
Tidsramme: Measured at pretreatment and weeks 2,4,6,8,9,26 and 36
Depression will be assessed using the Hamilton Depression Rating Scale, a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
Measured at pretreatment and weeks 2,4,6,8,9,26 and 36

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: George Alexopoulos, M.D., Weill Medical College of Cornell University
  • Hovedetterforsker: Patricia Arean, PhD, UW

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. mai 2014

Primær fullføring (Faktiske)

31. mars 2020

Studiet fullført (Faktiske)

31. mars 2020

Datoer for studieregistrering

Først innsendt

25. februar 2014

Først innsendt som oppfylte QC-kriteriene

11. mars 2014

Først lagt ut (Anslag)

13. mars 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. juni 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. juni 2021

Sist bekreftet

1. juni 2021

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

We intend to share de-identified data once study is complete

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. .

Kliniske studier på Dyp depresjon

Kliniske studier på Problem Solving Therapy

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