Depression, UnipolarREDSNCT03246789

Reaching and Engaging Depressed Senior Center Clients (REDS)

A study testing Engage-M and Wellness in Mind and Body in people with Depression, Unipolar and Mental Health Disorder, run by Weill Medical College of Cornell University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 55 to 100 years
Conditions the study is for: Depression, Unipolar, Mental Health Disorder
What is being tested?: Engage-M and Wellness in Mind and Body
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2018to 9 Jun 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Weill Cornell Medicine
New York, New York, 10065

Other trials in United States

About this study

Official title: Reaching and Engaging Depressed Senior Center Clients

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.

Read the 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.

Conditions: Depression, Unipolar, Mental Health Disorder
Being tested: Engage-M, Wellness in Mind and Body
Medical subject headings: Depressive Disorder, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Engage-MBehavioural
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 BodyBehavioural
Also called W-MH
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.

Study groups in NCT03246789
Study group	Role	What they receive
Engage-M	Experimental	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. Receives: Behavioral: Engage-M
Wellness in Mind and Body (W-MH)	Active comparator	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. Receives: Behavioral: Wellness in Mind and Body

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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 (1)

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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20189 Jun 2020

First posted11 Aug 2017
Study start1 Jan 2018
Primary completion9 Jun 2020
Study completion9 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Depression, UnipolarStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03246789
Sponsor's protocol ID: 1704018114
Other IDs: P50MH113838
Acronym: REDS
Status last verified: Feb 2022
First submitted: 3 Aug 2017
Last updated: 19 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reaching and Engaging Depressed Senior Center Clients
ClinicalTrials.gov ID: NCT03246789
Acronym / sponsor ID: REDS / 1704018114
Conditions: Depression, Unipolar, Mental Health Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Collaborators: New York City Department for the Aging, National Institute of Mental Health (NIMH)
Study start: 1 Jan 2018 (actual)
Primary completion: 9 Jun 2020 (actual)
Study completion: 9 Jun 2020 (actual)
First posted: 11 Aug 2017 (actual)
Results: Posted 3 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Engage-M	Experimental	Behavioral: Engage-MParticipants 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.
Wellness in Mind and Body (W-MH)	Active comparator	Behavioral: Wellness in Mind and BodyParticipants 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.

Who may qualify

Ages: 55 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (3 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Engage-MEngage 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.	Behavioural	Engage-M
Wellness in Mind and BodyAlso: W-MHAn 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.	Behavioural	Wellness in Mind and Body (W-MH)

Primary outcome

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 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.

1 secondary outcome

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.

Results and safety

Results posted to the registry on 3 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Engage-M	24	24
Wellness in Mind and Body (W-MH)	15	15

Primary outcome: 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.. Mean (Standard Deviation). Unit: score on a scale

Measure	Engage-M n = 24	Wellness in Mind and Body (W-MH) n = 15
Baseline	21.21 (5.38)	21 (3.85)
Week 6	18.5 (5.88)	15.77 (6.18)
Week 9	15.86 (6.78)	15.86 (4.38)
Week 12	15.36 (5.69)	13.21 (6.25)

Engage-M vs Wellness in Mind and Body (W-MH): Mean Difference (Final Values): 2.15 (95% CI -2.09 to 6.39), p = 0.31, t-test, 2 sided

Population analysed: Engage-M: Two participants completed only their baseline assessment. Additionally, two participants did not attend their Week-6 assessment, and one participant did not attend their Week-9 assessment. Wellness in Mind and Body (W-MH): One participant completed only their baseline assessment. Additionally, one participant did not attend their Week-6 assessment.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Each participant was monitored for adverse events for twelve weeks after the completion of their baseline assessment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Engage-M	0 of 24 (0%)	0 of 24 (0%)	0 of 24
Wellness in Mind and Body (W-MH)	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

George Alexopoulos, MD study director

Weill Medical College of Cornell University

Patricia Marino, PhD principal investigator

Weill Medical College of Cornell University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Engage-M and Wellness in Mind and Body in people with Depression, Unipolar and Mental Health Disorder, run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03246789.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022; AzTrials last refreshed its copy on 30 Oct 2026.