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Completed

NCT Number: NCT01698255

Psychotherapy for Late Life Depression

This randomized pilot study will test the feasibility of a behavioral intervention for late life depression. Enrolled participants will receive 9 weeks of a specialized form of psychotherapy we call "ENGAGE" or standard of care psychotherapy. ENGAGE is a stepped care psychotherapy based on what is currently known about older adults' response to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until individuals recover from their depression. The treatment components of ENGAGE were selected to match the most common problems seen in older adults with depression. They include instructing the participant in basic problem solving techniques and encouraging re-engagement in rewarding activities.

Participants will be depressed, older adult clients of Westchester Jewish Community Services or outpatient research subjects recruited by the Cornell Institute of Geriatric Psychiatry. In addition to receiving therapy, study participants will also undergo research assessments at the beginning of the study and then at weeks 6 and 9.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Westchester Jewish Community Services, Hartsdale, New York, United States

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About this study

A concern about existing psychotherapies is that, while effective in depression, community clinicians find them difficult to implement in older people, particularly those with medical illnesses or disability. As a consequence evidence-based psychotherapies are utilized by a small number of specialized clinicians and offered to small number of select patients.

ENGAGE approaches these problems with a four prong strategy: 1) It developed a brief treatment program consisting of psychotherapeutic components of known efficacy. 2) Among them, ENGAGE selected components most pertinent to older adults. 3) ENGAGE distilled and simplified these components so that they can be accessible to most depressed older patients and taught to large numbers of clinicians. 4) To further simplify and personalize its administration, ENGAGE relies on a stepped approach focusing on engagement in rewarding social and physical activities (a form of behavioral activation), and when needed, adding techniques for management of emotionality (emotional control), negativity bias, and apathy. The self-correcting and least restrictive nature of stepped care approaches has appeal from patient cost/time efficiency and personalized treatment perspective. This project aims to further develop ENGAGE, to study the feasibility of training professionals (master's level social workers) offering care to depressed elderly patients in the community, to obtain preliminary data of its efficacy compared to community-based therapy (CT), and to prepare for an effectiveness (R01) study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(WJCS Participants):

  • Current client of Westchester Jewish Community Services;
  • Age 60 years or older;
  • Diagnosis of depression as determined by WJCS therapists;
  • Command of English sufficient to participate in talking therapy;

Inclusion criteria

(Cornell Participants):

  • Age 60 years or older;
  • Depression as determined by a Patient Health Questionnaire-9 score of 6 or higher (with at least one item being "depressed mood" or "loss of interest/pleasure");
  • Command of English sufficient to participate in talking therapy;

Exclusion criteria

  • Dementia: Mini Mental State Exam score below 24 or clinical diagnosis of dementia by Diagnostic and Statistical Manual IV;
  • High suicide risk, i.e. intent or plan to attempt suicide in near future;
  • History of psychiatric diagnoses other than major depressive disorder or generalized anxiety disorder (including bi-polar depression, psychotic depression, schizoaffective disorders).

Treatment and study plan

Engage

Behavioral

Standard of Care Psychotherapy

Behavioral

Primary outcomes

  1. Change in Depression

    Time frame: 3 months

    To compare the effectiveness of the ENGAGE intervention in reducing depressive symptoms with that of the standard of care psychotherapy. We will assess severity of depression at Baseline. 6 weeks and 3 months using the Hamilton Depression Rating Scale as the primary measure.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: ENGAGE-II

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 2, 2012
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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