Psychotherapy for Late Life Depression (ENGAGE-II)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Weill Medical College of Cornell University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01698255
First received: August 2, 2012
Last updated: September 12, 2013
Last verified: September 2013

August 2, 2012
September 12, 2013
March 2012
April 2014   (final data collection date for primary outcome measure)
Change in Depression [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01698255 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Psychotherapy for Late Life Depression
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Depression
  • Behavioral: ENGAGE
  • Behavioral: Standard of Care Psychotherapy
  • Experimental: ENGAGE

    ENGAGE is a stepped care psychotherapy based on what is known about how older adults respond 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 people are recovered from their depression. The steps of ENGAGE are:

    1. basic social and physical engagement, which has been found to be a very effective depression strategy for most older adults;
    2. the addition of strategies to address clinical features of depression interfering with treatment engagement, namely affect regulation, pessimism, and disorganization.
    Intervention: Behavioral: ENGAGE
  • Active Comparator: Standard of Care Psychotherapy
    The comparison group for this study will be the current standard of care psychotherapy offered by Westchester Jewish Community Services (WJCS) therapists. This type of psychotherapy is often supportive or eclectic in nature. Therapists will focus on helping the subject to express feelings and focus on strengths and abilities in working through current difficulties and transitions. Therapists assigned to provide standard psychotherapy to eligible participants will receive training and supervision from WJCS staff consistent with agency practice.
    Intervention: Behavioral: Standard of Care Psychotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
April 2014
April 2014   (final data collection date for primary outcome measure)

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).
Both
60 Years and older
No
Contact: Patrick J Raue, Ph.D. 914-997-8384 praue@med.cornell.edu
United States
 
NCT01698255
P30 MH085943-05, 11108011880
Yes
Weill Medical College of Cornell University
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Not Provided
Weill Medical College of Cornell University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP