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| ID | Type | Description | Link |
|---|---|---|---|
| P50MH113838 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| New York City Department for the Aging | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Engage-M | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Alexopoulos, MD | Weill Medical College of Cornell University | Study Director |
| Patricia Marino, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10065 | United States |
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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Per NIMH guidelines.
All users will first provide to the ALACRITY Center and the co-Investigators with a proposal of hypotheses, variables needed to test these hypotheses, and plans for dissemination of findings. All users will indicate in a signed document: (1) a commitment to using the data only for research purposes; (2) a plan for securing the data; (3) an agreement to either destroying or returning the data once analyses are completed; and (4) an agreement to not share data with other users and to direct all such requests to The ALACRITY Center.
Findings will be reported in scientific meetings and publications promptly. Consistent with NIH policy, publications will be deposited at PubMed Central. The data from this research will be made available for integration with other datasets of the ALACRITY Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Engage-M | 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-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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Engage-M | 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-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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. |
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Each participant was monitored for adverse events for twelve weeks after the completion of their baseline assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Engage-M | 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-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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Patricia Marino | Weill Cornell Institute of Geriatric Psychiatry | (914) 997-8691 | pam2029@med.cornell.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 26, 2021 | Feb 4, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| D006262 | Health |
| ID | Term |
|---|---|
| D011154 | Population Characteristics |
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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.
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|
| Wellness in Mind and Body | Behavioral | 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. |
|
|
| 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. |
| Assessed after REDS sessions completed at six, nine, and twelve weeks after study enrollment. |
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG000 | Engage-M | 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-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. |
| OG001 | 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. 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. |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. |
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| Other Pre-specified | 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.
| Engage-M: 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 did not attend their Week-6 assessment. | Posted | Mean | Standard Deviation | score on a scale | Assessed after REDS sessions completed at six, nine, and twelve weeks after study enrollment. |
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| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | 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. 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. | 0 | 15 | 0 | 15 | 0 | 15 |
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| Baseline - Domain 2 |
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| Baseline - Domain 3 |
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| Baseline - Domain 4 |
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| Week 6 - Domain 1 |
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| Week 6 - Domain 2 |
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| Week 6 - Domain 3 |
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| Week 6 - Domain 4 |
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| Week 9 - Domain 1 |
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| Week 9 - Domain 2 |
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| Week 9 - Domain 3 |
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| Week 9 - Domain 4 |
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| Week 12 - Domain 1 |
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| Week 12 - Domain 2 |
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| Week 12 - Domain 3 |
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| Week 12 - Domain 4 |
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| 0.50 |
| Mean Difference (Final Values) |
| -0.87 |
| 2-Sided |
| 95 |
| -3.48 |
| 1.74 |
| Superiority |
| Domain #3, Week 12 | t-test, 2 sided | 0.02 | Mean Difference (Final Values) | -1.58 | 2-Sided | 95 | -2.88 | -0.28 | Superiority |
| Domain 4, Week 12 | t-test, 2 sided | 0.98 | Mean Difference (Final Values) | -0.05 | 2-Sided | 95 | -3.63 | 3.53 | Superiority |
| Week 6 - #2 |
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| Week 6 - #3 |
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| Week 9 - #1 |
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| Week 9 - #2 |
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| Week 9 - #3 |
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| Week 12 - #1 |
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| Week 12 - #2 |
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| Week 12 - #3 |
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| 0.48 |
| Mean Difference (Final Values) |
| -0.18 |
| 2-Sided |
| 95 |
| -0.69 |
| 0.33 |
| Superiority |
| t-test, 2 sided | 0.48 | Mean Difference (Final Values) | 0.18 | 2-Sided | 95 | -0.33 | 0.69 | Superiority |