Reaching and Engaging Depressed Senior Center Clients (REDS)

Mental Health Disorder Clinical Trial

— REDS  

Official title:

Reaching and Engaging Depressed Senior Center Clients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03246789
• Other study ID #: 1704018114
• Secondary ID: P50MH113838
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: June 9, 2020

Study information

• Verified date: February 2022
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 9, 2020
• Est. primary completion date: June 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Depression, Unipolar
• Depressive Disorder
• Mental Disorders
• Mental Health Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute of Mental Health (NIMH), New York City Department for the Aging

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Satisfaction With Study Intervention (CSQ)	Client satisfaction with study intervention as measured by the Client Satisfaction Questionnaire (CSQ) in both treatments. The questionnaire comprises three questions, rated on a scale of 1-4. A higher score indicates a greater degree of client satisfaction.; To what extent has the study therapist met your needs? 4=Almost all of my needs have been met 3=Most of my needs have been met 2=Some of my needs have been met 1=None of my needs have been met; In an overall sense, how satisfied are you with the services that you have received? 4=Very satisfied 3=Mostly satisfied 2=Indifferent or mildly dissatisfied 1=Quite dissatisfied; If you were to seek help again, would you come back to the study therapist you are currently seeing? 4=Yes, definitely 3=Yes, I think so 2=No, I don't think so 1=No, definitely not	Assessed after REDS sessions completed at six, nine, and twelve weeks after study enrollment.
Primary	Change in Clinically Significant Depressive Symptoms (MADRS)	In both conditions, the change in clinically significant depressive symptoms as measured on the Montgomery Asberg Depression Rating Scale (MADRS). The scale captures the severity of ten common symptoms of depression. The combined score yields a value between 0-60. Higher scores indicate more severe depression, which benchmarks as follows: 0 to 6: normal/symptoms absent; 7 to 19: mild depression; 20 to 34: moderate depression; >34: severe depression.	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	Change in Assessment of Quality of Life (WHO-QOL)	In both conditions, change in assessment of quality of life is measured by the World Health Organization Quality of Life (WHOQOL) scale. This scale measures quality of life across four domains: 1) Physical Health 2) Psychological 3) Social relationships and 4) Environment. A higher score in any domain indicates a better outcome, and min/max values for each domain are as follows: 1) 7-35 2) 6-30 3) 3-15 4) 8-40.	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.