Reaching and Engaging Depressed Senior Center Clients (REDS)

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Completed
CT.gov ID
NCT03246789
Collaborator
New York City Department for the Aging (Other), National Institute of Mental Health (NIMH) (NIH)
39
1
2
29.2
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Engage-M
  • Behavioral: Wellness in Mind and Body
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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)
Primary Purpose:
Treatment
Official Title:
Reaching and Engaging Depressed Senior Center Clients
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
Jun 9, 2020
Actual Study Completion Date :
Jun 9, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

Active Comparator: 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.

Behavioral: 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.
Other Names:
  • W-MH
  • Outcome Measures

    Primary Outcome Measures

    1. Change in Clinically Significant Depressive Symptoms (MADRS) [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.

    Secondary Outcome Measures

    1. 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.]

      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.

    Other Outcome Measures

    1. Change in Satisfaction With Study Intervention (CSQ) [Assessed after REDS sessions completed at six, nine, and twelve weeks after study enrollment.]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Weill Cornell Medicine New York New York United States 10065

    Sponsors and Collaborators

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

    Investigators

    • Study Director: George Alexopoulos, MD, Weill Medical College of Cornell University
    • Principal Investigator: Patricia Marino, PhD, Weill Medical College of Cornell University

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Weill Medical College of Cornell University
    ClinicalTrials.gov Identifier:
    NCT03246789
    Other Study ID Numbers:
    • 1704018114
    • P50MH113838
    First Posted:
    Aug 11, 2017
    Last Update Posted:
    Mar 3, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Engage-M Wellness in Mind and Body (W-MH)
    Arm/Group Description 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. 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.
    Period Title: Overall Study
    STARTED 24 15
    COMPLETED 24 15
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Engage-M Wellness in Mind and Body (W-MH) Total
    Arm/Group Description 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. 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. Total of all reporting groups
    Overall Participants 24 15 39
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    71.88
    (6.91)
    73.60
    (7.40)
    72.54
    (7.06)
    Sex: Female, Male (Count of Participants)
    Female
    21
    87.5%
    14
    93.3%
    35
    89.7%
    Male
    3
    12.5%
    1
    6.7%
    4
    10.3%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    4
    16.7%
    0
    0%
    4
    10.3%
    Not Hispanic or Latino
    20
    83.3%
    15
    100%
    35
    89.7%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    1
    4.2%
    1
    6.7%
    2
    5.1%
    White
    20
    83.3%
    14
    93.3%
    34
    87.2%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    3
    12.5%
    0
    0%
    3
    7.7%
    Region of Enrollment (participants) [Number]
    United States
    24
    100%
    15
    100%
    39
    100%

    Outcome Measures

    1. Primary Outcome
    Title Change in Clinically Significant Depressive Symptoms (MADRS)
    Description 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.
    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.

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Engage-M Wellness in Mind and Body (W-MH)
    Arm/Group Description 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. 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.
    Measure Participants 24 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)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Engage-M, Wellness in Mind and Body (W-MH)
    Comments Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.31
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.15
    Confidence Interval (2-Sided) 95%
    -2.09 to 6.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Change in Assessment of Quality of Life (WHO-QOL)
    Description 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.
    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.

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Engage-M Wellness in Mind and Body (W-MH)
    Arm/Group Description 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. 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.
    Measure Participants 24 15
    Baseline - Domain 1
    22.14
    (4.10)
    20.87
    (3.23)
    Baseline - Domain 2
    17.81
    (3.43)
    17.50
    (3.03)
    Baseline - Domain 3
    8.30
    (2.62)
    9.36
    (1.43)
    Baseline - Domain 4
    29.00
    (4.01)
    30.80
    (3.76)
    Week 6 - Domain 1
    22.16
    (3.78)
    21.00
    (3.57)
    Week 6 - Domain 2
    18.00
    (3.35)
    18.83
    (2.52)
    Week 6 - Domain 3
    8.92
    (2.14)
    9.00
    (2.49)
    Week 6 - Domain 4
    31.42
    (4.34)
    30.25
    (5.05)
    Week 9 - Domain 1
    22.67
    (2.37)
    22.08
    (4.42)
    Week 9 - Domain 2
    18.19
    (3.28)
    19.08
    (4.41)
    Week 9 - Domain 3
    9.08
    (2.68)
    10.00
    (1.49)
    Week 9 - Domain 4
    31.43
    (4.04)
    29.69
    (4.52)
    Week 12 - Domain 1
    20.68
    (4.19)
    22.15
    (3.76)
    Week 12 - Domain 2
    17.59
    (3.84)
    18.46
    (3.67)
    Week 12 - Domain 3
    8.69
    (2.55)
    10.27
    (1.27)
    Week 12 - Domain 4
    30.18
    (4.69)
    30.23
    (5.33)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Engage-M, Wellness in Mind and Body (W-MH)
    Comments Domain #1, Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.28
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.47
    Confidence Interval (2-Sided) 95%
    -4.22 to 1.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Engage-M, Wellness in Mind and Body (W-MH)
    Comments Domain #2, Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.50
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.87
    Confidence Interval (2-Sided) 95%
    -3.48 to 1.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Engage-M, Wellness in Mind and Body (W-MH)
    Comments Domain #3, Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.02
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.58
    Confidence Interval (2-Sided) 95%
    -2.88 to -0.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Engage-M, Wellness in Mind and Body (W-MH)
    Comments Domain 4, Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.98
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.05
    Confidence Interval (2-Sided) 95%
    -3.63 to 3.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Other Pre-specified Outcome
    Title Change in Satisfaction With Study Intervention (CSQ)
    Description 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
    Time Frame Assessed after REDS sessions completed at six, nine, and twelve weeks after study enrollment.

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Engage-M Wellness in Mind and Body (W-MH)
    Arm/Group Description 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. 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.
    Measure Participants 22 14
    Week 6 - #1
    2.80
    (1.06)
    2.23
    (0.73)
    Week 6 - #2
    3.35
    (0.88)
    2.77
    (0.93)
    Week 6 - #3
    3.50
    (0.76)
    3.69
    (0.48)
    Week 9 - #1
    3.00
    (1.00)
    2.43
    (0.65)
    Week 9 - #2
    3.57
    (0.75)
    3.14
    (0.77)
    Week 9 - #3
    3.70
    (0.57)
    3.50
    (0.76)
    Week 12 - #1
    2.68
    (0.95)
    2.71
    (0.83)
    Week 12 - #2
    3.18
    (0.80)
    3.36
    (0.63)
    Week 12 - #3
    3.68
    (0.72)
    3.50
    (0.76)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Engage-M, Wellness in Mind and Body (W-MH)
    Comments Domain #1, Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.92
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.03
    Confidence Interval (2-Sided) 95%
    -0.64 to 0.58
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Engage-M, Wellness in Mind and Body (W-MH)
    Comments Domain #2, Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.48
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.18
    Confidence Interval (2-Sided) 95%
    -0.69 to 0.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Engage-M, Wellness in Mind and Body (W-MH)
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.48
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.18
    Confidence Interval (2-Sided) 95%
    -0.33 to 0.69
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame Each participant was monitored for adverse events for twelve weeks after the completion of their baseline assessment.
    Adverse Event Reporting Description
    Arm/Group Title Engage-M Wellness in Mind and Body (W-MH)
    Arm/Group Description 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. 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.
    All Cause Mortality
    Engage-M Wellness in Mind and Body (W-MH)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/24 (0%) 0/15 (0%)
    Serious Adverse Events
    Engage-M Wellness in Mind and Body (W-MH)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/24 (0%) 0/15 (0%)
    Other (Not Including Serious) Adverse Events
    Engage-M Wellness in Mind and Body (W-MH)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/24 (0%) 0/15 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Patricia Marino
    Organization Weill Cornell Institute of Geriatric Psychiatry
    Phone (914) 997-8691
    Email pam2029@med.cornell.edu
    Responsible Party:
    Weill Medical College of Cornell University
    ClinicalTrials.gov Identifier:
    NCT03246789
    Other Study ID Numbers:
    • 1704018114
    • P50MH113838
    First Posted:
    Aug 11, 2017
    Last Update Posted:
    Mar 3, 2022
    Last Verified:
    Feb 1, 2022