- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02086201
Comparing Engage to PST for Late Life Depression (Engage)
Stepped, Reward-exposure Based Therapy vs. PST in Late Life Depression
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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New York
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White Plains, New York, Förenta staterna, 10605
- Weill Medical College of Cornell University
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Washington
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Seattle, Washington, Förenta staterna, 98195
- University of Washington Department of Psychiatry and Behavioral Sciences
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / 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.
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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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Depression
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: George Alexopoulos, M.D., Weill Medical College of Cornell University
- Huvudutredare: Patricia Arean, PhD, UW
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STUDY00001739
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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