Clinical trial NCT03246789: Reaching and Engaging Depressed Senior Center Clients (REDS)
Official title: Reaching and Engaging Depressed Senior Center Clients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Unipolar
Mental Health Disorder
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: New York City Department for the Aging
name: National Institute of Mental Health (NIMH)
First posted: 2017-08-11
Enrollment: 39
Sex: ALL
Minimum age (years): 55
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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).

Primary outcomes:
measure: Change in Clinically Significant Depressive Symptoms (MADRS)
timeFrame: 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.
Secondary outcomes:
measure: Change in Assessment of Quality of Life (WHO-QOL)
timeFrame: 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.
Other outcomes:
measure: Change in Satisfaction With Study Intervention (CSQ)
timeFrame: Assessed after REDS sessions completed at six, nine, and twelve weeks after study enrollment.
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: George Alexopoulos, MD
role: STUDY_DIRECTOR
affiliation: Weill Medical College of Cornell University
name: Patricia Marino, PhD
role: PRINCIPAL_INVESTIGATOR
References: