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 : August 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Depression, Unipolar Mental Health Disorder||Behavioral: Engage-M Behavioral: Wellness in Mind and Body||Not Applicable|
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|
|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)|
|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|
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.
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
- 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).
- 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.
- 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.
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
|Contact: Patricia Marino, PhDemail@example.com|
|United States, New York|
|Weill Cornell Medicine||Recruiting|
|New York, New York, United States, 10065|
|Contact: George Alexopoulos, MD 914-997-4331|
|Study Director:||George Alexopoulos, MD||Weill Medical College of Cornell University|
|Principal Investigator:||Patricia Marino, PhD||Weill Medical College of Cornell University|