NCT03246789|CompletedResultsDMC
Reaching and Engaging Depressed Senior Center Clients (REDS)
REDS
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Sponsor study identifier
Secondary identifiers
NIH
interventional
39
1 country
1
Study Start
January 1, 2018
Actual (reported)Primary Completion
June 9, 2020
Actual (reported)Study Completion
June 9, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 9, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 3, 2017
Actual (reported)August 11, 2017
Actual (reported)January 1, 2018
Actual (reported)June 9, 2020
Actual (reported)June 9, 2020
Actual (reported)March 3, 2022
Actual (reported)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.
Change in Assessment of Quality of Life (WHO-QOL)
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.
Change in Satisfaction With Study Intervention (CSQ)
Assessed after REDS sessions completed at six, nine, and twelve weeks after study enrollment.
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.
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.
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.
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.
Weill Cornell Medicine
New York, New York, 10065, United States
George Alexopoulos, MD
Weill Medical College of Cornell University
Patricia Marino, PhD
Weill Medical College of Cornell University
39 participants (actual enrollment reported by the registry).
First Submitted
Effect of Tao Calligraphy Meditation and Energized Water on Depression
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
August 3, 2017
First Posted
August 11, 2017
Study Start
January 1, 2018
Actual (reported)Primary Completion
June 9, 2020
Actual (reported)Study Completion
June 9, 2020
Actual (reported)Last Updated
October 19, 2022
Results First Posted
March 3, 2022
Record last verified: 2022-02
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.
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Source: ClinicalTrials.gov.
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