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Reaching and Engaging Depressed Senior Center Clients (REDS) (REDS)

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ClinicalTrials.gov Identifier: NCT03246789
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : February 22, 2018
Sponsor:
Collaborators:
New York City Department for the Aging
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
The purpose of this study is to test the feasibility of two types of group therapy sessions. The research is being done because the researchers are trying to learn if these approaches could be used by therapist in the community social service agencies to treat older adults with depression. There are two study groups. One group is a form of group therapy called "Engage-M", which encourages subjects to engage in physical and social activities that they find pleasurable or rewarding. One group is another form of group therapy called, "Wellness in Mind and Body", which focuses on education and de-stigmatization of health and mental health conditions.

Condition or disease Intervention/treatment Phase
Depression, Unipolar Mental Health Disorder Behavioral: Engage-M Behavioral: Wellness in Mind and Body Not Applicable

Detailed Description:

In response to the large numbers of senior center clients who suffer from untreated depression, we have partnered with the NYC Department for the Aging (DFTA) to develop SMART-MH, a community care model that can be embedded in senior centers to improve recognition, referral, and adherence to depression treatment. The investigators also developed and tested Engage, a stepped-care therapy streamlined to use "reward exposure" as its principal intervention based on the assumption that dysfunction of the reward networks is central to the pathogenesis of depression. With senior center partners and a mobile technology team, the investigators redesigned Engage-M so that it can be used in a group format by licensed clinical social workers (LCSWs) of Senior Centers. Mobile technology provides probes for client adherence and offers to therapists easy to review summary records of mood, activity, and social interaction that can be used to target their sessions. The investigators have integrated SMART-MH and Engage-M into a comprehensive community care model "Reaching and Engaging Depressed Senior Center Clients" (REDS).

The specific aims of this developmental project are to: 1. Finalize the REDS protocol and assess feasibility of training; 2. Prepare an Operations' Manual; 3. Examine reach, feasibility, and acceptability of REDS; 4. Examine engagement of behavioral targets and preliminary effectiveness; and 5. Collect information on REDS cost, barriers to implementation, and potential savings in health care utilization.

The investigators will randomly assign four senior centers to offer either Engage-M (N=40), the treatment offered by REDS (1 individual and 8 weekly group sessions) or 8 group sessions "Wellness in Mind and Body" plus mental health referral (W-MH; N=20). The participants will have clinically significant depressive symptoms (PHQ-9>10) and will be older and middle-aged adults (55+); 12.6% of the NYC senior center clients are aged 55-65 years. Clients will be identified by senior center staff trained in SMART-MH strategies. The investigators will offer additional training to staff of all centers on SMART-MH outreach, depression screening, and treatment engagement. The investigators will train and provide weekly supervision to 2 or more LCSWs per center of the two centers assigned to Engage-M. The investigators will not offer training or supervision to senior center staff leading the groups of W-MH but will provide oversight so that clients receive mental health referrals and are encouraged to attend weekly Wellness group meetings.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Investigators will randomly assign four senior centers to offer either Engage-M (N=40), the treatment offered by REDS (1 individual and 8 weekly group sessions) or 8 group sessions "Wellness in Mind and Body" plus mental health referral (W-MH; N=20). Participants will have clinically significant depressive symptoms (PHQ-9>10) and will be older and middle-aged adults (55+). Clients will be identified by senior center staff trained in SMART-MH strategies. Investigators will offer additional training to staff of all centers on SMART-MH outreach, depression screening, and treatment engagement. Investigators will train and provide weekly supervision to 2 or more LCSWs per center of the two centers assigned to Engage-M. Investigators will not offer training or supervision to senior center staff leading the groups of W-MH but will provide oversight so that clients receive mental health referrals and are encouraged to attend weekly Wellness group meetings.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reaching and Engaging Depressed Senior Center Clients
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: Engage-M
Participants will meet individually with a therapist once before beginning weekly group sessions for eight weeks. Each weekly session will last approximately 50 minutes. Study investigators have trained Engage-M therapists to provide participants with a group therapy approach called Engage-M. During the weekly therapy sessions, therapists will encourage participants to engage in physical and social activities that you find pleasurable or rewarding.
Behavioral: Engage-M
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.

Active Comparator: Wellness in Mind and Body (W-MH)
Participants will meet with a therapist for group therapy once a week for eight weeks. Each weekly session will last approximately 50 minutes. During these weekly sessions, the therapist will educate participants about health and mental health.
Behavioral: Wellness in Mind and Body
An active intervention focusing on psychoeducation and de-stigmatization of health and mental health conditions. These sessions are commonly part of senior centers programs. W-MH will offer mental health referral to a clinic or primary care physician as part of senior center procedures for clients with positive PHQ-9s.
Other Name: W-MH




Primary Outcome Measures :
  1. Change in clinically significant depressive symptoms (MADRS) [ Time Frame: These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study to document change in depressive symptoms. ]
    In both conditions, the reduction of clinically significant depressive symptoms as measured on the Montgomery Asberg Depression Rating Scale (MADRS).


Secondary Outcome Measures :
  1. Change in assessment of quality of life (WHO-QOL) [ Time Frame: These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study to document change in assessment of quality of life. ]
    In both conditions, improvement in assessment of quality of life measured by the World Health Organization Quality of Life (WHOQOL) scale.


Other Outcome Measures:
  1. Change in satisfaction with study intervention (CSQ) [ Time Frame: Assessed after REDS sessions completed at six, nine, and twelve weeks after study enrollment. ]
    Client satisfaction with study intervention as measured by the Client Satisfaction Questionnaire (CSQ) in both treatments.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 55 years+
  • PHQ-9≥10
  • English or Spanish speaking
  • MMSE ≥ 24
  • Capacity to provide written consent for both research assessment and the Engage-M intervention.

Exclusion Criteria:

  • Current active suicidal ideation defined by MADRS Suicide Item ≥ 4 (Probably better off dead. Suicidal thoughts are common, and suicide is considered as a possible solution, but without specific plans or intention).
  • Presence of psychiatric diagnoses other than unipolar, non-psychotic major depression pr generalized anxiety disorder by SCID-V.
  • Severe or life-threatening medical illness (e.g. end-stage organ failure).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03246789


Contacts
Contact: Patricia Marino, PhD 914-997-8691 pam2029@med.cornell.edu

Locations
United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: George Alexopoulos, MD    914-997-4331      
Sponsors and Collaborators
Weill Medical College of Cornell University
New York City Department for the Aging
National Institute of Mental Health (NIMH)
Investigators
Study Director: George Alexopoulos, MD Weill Medical College of Cornell University

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03246789     History of Changes
Other Study ID Numbers: 1704018114
P50MH113838 ( U.S. NIH Grant/Contract )
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The Center will share its data via the NIMH Data Archive (NDA). The resource sharing plan is formulated in accordance with the NDA Data Sharing Terms and Conditions. Further, the Center will use NDA technologies to submit data in accordance with the NDA Data Sharing Terms and Conditions.

The investigators will comply with NIMH's procedures for data deposition into NDCT, and will let NDCT policies dictate the timetable upon which and avenues through which others will be allowed to access those data. Investigators will make the dataset available to other researchers after the main results have been published. Investigators will de-identify the data in the final datasets prior to release for sharing. To ensure data and participant security, investigators will make the data available to users only under a data-sharing agreement.

Time Frame: Per NIMH guidelines.
Access Criteria:

All users will first provide to the ALACRITY Center and the co-Investigators with a proposal of hypotheses, variables needed to test these hypotheses, and plans for dissemination of findings. All users will indicate in a signed document: (1) a commitment to using the data only for research purposes; (2) a plan for securing the data; (3) an agreement to either destroying or returning the data once analyses are completed; and (4) an agreement to not share data with other users and to direct all such requests to The ALACRITY Center.

Findings will be reported in scientific meetings and publications promptly. Consistent with NIH policy, publications will be deposited at PubMed Central. The data from this research will be made available for integration with other datasets of the ALACRITY Center.


Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Mental Disorders
Depressive Disorder
Mood Disorders