Trial Outcomes & Findings for Reaching and Engaging Depressed Senior Center Clients (REDS) (NCT NCT03246789)
NCT ID: NCT03246789
Last Updated: 2022-10-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
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.
Results posted on
2022-10-19
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
15
|
|
Overall Study
COMPLETED
|
24
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reaching and Engaging Depressed Senior Center Clients (REDS)
Baseline characteristics by cohort
| Measure |
Engage-M
n=24 Participants
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.
|
Wellness in Mind and Body (W-MH)
n=15 Participants
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
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.88 years
STANDARD_DEVIATION 6.91 • n=5 Participants
|
73.60 years
STANDARD_DEVIATION 7.40 • n=7 Participants
|
72.54 years
STANDARD_DEVIATION 7.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
15 participants
n=7 Participants
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
Engage-M
n=24 Participants
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.
|
Wellness in Mind and Body (W-MH)
n=15 Participants
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.
|
|---|---|---|
|
Change in Clinically Significant Depressive Symptoms (MADRS)
Baseline
|
21.21 score on a scale
Standard Deviation 5.38
|
21 score on a scale
Standard Deviation 3.85
|
|
Change in Clinically Significant Depressive Symptoms (MADRS)
Week 6
|
18.5 score on a scale
Standard Deviation 5.88
|
15.77 score on a scale
Standard Deviation 6.18
|
|
Change in Clinically Significant Depressive Symptoms (MADRS)
Week 9
|
15.86 score on a scale
Standard Deviation 6.78
|
15.86 score on a scale
Standard Deviation 4.38
|
|
Change in Clinically Significant Depressive Symptoms (MADRS)
Week 12
|
15.36 score on a scale
Standard Deviation 5.69
|
13.21 score on a scale
Standard Deviation 6.25
|
SECONDARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
Engage-M
n=24 Participants
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.
|
Wellness in Mind and Body (W-MH)
n=15 Participants
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.
|
|---|---|---|
|
Change in Assessment of Quality of Life (WHO-QOL)
Baseline - Domain 1
|
22.14 score on a scale
Standard Deviation 4.10
|
20.87 score on a scale
Standard Deviation 3.23
|
|
Change in Assessment of Quality of Life (WHO-QOL)
Baseline - Domain 2
|
17.81 score on a scale
Standard Deviation 3.43
|
17.50 score on a scale
Standard Deviation 3.03
|
|
Change in Assessment of Quality of Life (WHO-QOL)
Baseline - Domain 3
|
8.30 score on a scale
Standard Deviation 2.62
|
9.36 score on a scale
Standard Deviation 1.43
|
|
Change in Assessment of Quality of Life (WHO-QOL)
Baseline - Domain 4
|
29.00 score on a scale
Standard Deviation 4.01
|
30.80 score on a scale
Standard Deviation 3.76
|
|
Change in Assessment of Quality of Life (WHO-QOL)
Week 6 - Domain 1
|
22.16 score on a scale
Standard Deviation 3.78
|
21.00 score on a scale
Standard Deviation 3.57
|
|
Change in Assessment of Quality of Life (WHO-QOL)
Week 6 - Domain 2
|
18.00 score on a scale
Standard Deviation 3.35
|
18.83 score on a scale
Standard Deviation 2.52
|
|
Change in Assessment of Quality of Life (WHO-QOL)
Week 6 - Domain 3
|
8.92 score on a scale
Standard Deviation 2.14
|
9.00 score on a scale
Standard Deviation 2.49
|
|
Change in Assessment of Quality of Life (WHO-QOL)
Week 6 - Domain 4
|
31.42 score on a scale
Standard Deviation 4.34
|
30.25 score on a scale
Standard Deviation 5.05
|
|
Change in Assessment of Quality of Life (WHO-QOL)
Week 9 - Domain 1
|
22.67 score on a scale
Standard Deviation 2.37
|
22.08 score on a scale
Standard Deviation 4.42
|
|
Change in Assessment of Quality of Life (WHO-QOL)
Week 9 - Domain 2
|
18.19 score on a scale
Standard Deviation 3.28
|
19.08 score on a scale
Standard Deviation 4.41
|
|
Change in Assessment of Quality of Life (WHO-QOL)
Week 9 - Domain 3
|
9.08 score on a scale
Standard Deviation 2.68
|
10.00 score on a scale
Standard Deviation 1.49
|
|
Change in Assessment of Quality of Life (WHO-QOL)
Week 9 - Domain 4
|
31.43 score on a scale
Standard Deviation 4.04
|
29.69 score on a scale
Standard Deviation 4.52
|
|
Change in Assessment of Quality of Life (WHO-QOL)
Week 12 - Domain 1
|
20.68 score on a scale
Standard Deviation 4.19
|
22.15 score on a scale
Standard Deviation 3.76
|
|
Change in Assessment of Quality of Life (WHO-QOL)
Week 12 - Domain 2
|
17.59 score on a scale
Standard Deviation 3.84
|
18.46 score on a scale
Standard Deviation 3.67
|
|
Change in Assessment of Quality of Life (WHO-QOL)
Week 12 - Domain 3
|
8.69 score on a scale
Standard Deviation 2.55
|
10.27 score on a scale
Standard Deviation 1.27
|
|
Change in Assessment of Quality of Life (WHO-QOL)
Week 12 - Domain 4
|
30.18 score on a scale
Standard Deviation 4.69
|
30.23 score on a scale
Standard Deviation 5.33
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed after REDS sessions completed at six, nine, and twelve weeks after study enrollment.Population: 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.
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. 1. 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 2. 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 3. 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
Outcome measures
| Measure |
Engage-M
n=22 Participants
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.
|
Wellness in Mind and Body (W-MH)
n=14 Participants
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.
|
|---|---|---|
|
Change in Satisfaction With Study Intervention (CSQ)
Week 6 - #1
|
2.80 score on a scale
Standard Deviation 1.06
|
2.23 score on a scale
Standard Deviation 0.73
|
|
Change in Satisfaction With Study Intervention (CSQ)
Week 6 - #2
|
3.35 score on a scale
Standard Deviation 0.88
|
2.77 score on a scale
Standard Deviation 0.93
|
|
Change in Satisfaction With Study Intervention (CSQ)
Week 6 - #3
|
3.50 score on a scale
Standard Deviation 0.76
|
3.69 score on a scale
Standard Deviation 0.48
|
|
Change in Satisfaction With Study Intervention (CSQ)
Week 9 - #1
|
3.00 score on a scale
Standard Deviation 1.00
|
2.43 score on a scale
Standard Deviation 0.65
|
|
Change in Satisfaction With Study Intervention (CSQ)
Week 9 - #2
|
3.57 score on a scale
Standard Deviation 0.75
|
3.14 score on a scale
Standard Deviation 0.77
|
|
Change in Satisfaction With Study Intervention (CSQ)
Week 9 - #3
|
3.70 score on a scale
Standard Deviation 0.57
|
3.50 score on a scale
Standard Deviation 0.76
|
|
Change in Satisfaction With Study Intervention (CSQ)
Week 12 - #1
|
2.68 score on a scale
Standard Deviation 0.95
|
2.71 score on a scale
Standard Deviation 0.83
|
|
Change in Satisfaction With Study Intervention (CSQ)
Week 12 - #2
|
3.18 score on a scale
Standard Deviation 0.80
|
3.36 score on a scale
Standard Deviation 0.63
|
|
Change in Satisfaction With Study Intervention (CSQ)
Week 12 - #3
|
3.68 score on a scale
Standard Deviation 0.72
|
3.50 score on a scale
Standard Deviation 0.76
|
Adverse Events
Engage-M
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wellness in Mind and Body (W-MH)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Patricia Marino
Weill Cornell Institute of Geriatric Psychiatry
Phone: (914) 997-8691
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place