- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02086201
Comparing Engage to PST for Late Life Depression (Engage)
Stepped, Reward-exposure Based Therapy vs. PST in Late Life Depression
Studieoversikt
Status
Forhold
Intervensjon / Behandling
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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New York
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White Plains, New York, Forente stater, 10605
- Weill Medical College of Cornell University
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Washington
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Seattle, Washington, Forente stater, 98195
- University of Washington Department of Psychiatry and Behavioral Sciences
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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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.
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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.
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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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Depression
Tidsramme: Measured at pretreatment and weeks 2,4,6,8,9,26 and 36
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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.
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Measured at pretreatment and weeks 2,4,6,8,9,26 and 36
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: George Alexopoulos, M.D., Weill Medical College of Cornell University
- Hovedetterforsker: Patricia Arean, PhD, UW
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00001739
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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