Depression, Unipolar, Mental Health Disorder
Conditions
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.
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.
Interventions
BEHAVIORALEngage-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.
BEHAVIORALWellness 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.
Sponsors
New York City Department for the Aging
National Institute of Mental Health (NIMH)
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
55 Years to 100 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| 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. | 15 |
| Total | 39 |
Baseline characteristics
| Characteristic | Engage-M | Total | Wellness in Mind and Body (W-MH) |
|---|---|---|---|
| Age, Continuous | 71.88 years STANDARD_DEVIATION 6.91 | 72.54 years STANDARD_DEVIATION 7.06 | 73.60 years STANDARD_DEVIATION 7.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 4 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 35 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 34 Participants | 14 Participants |
| Region of Enrollment United States | 24 participants | 39 participants | 15 participants |
| Sex: Female, Male Female | 21 Participants | 35 Participants | 14 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 15 |
| other Total, other adverse events | 0 / 24 | 0 / 15 |
| serious Total, serious adverse events | 0 / 24 | 0 / 15 |
Outcome results
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.
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.
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engage-M | Change in Clinically Significant Depressive Symptoms (MADRS) | Week 12 | 15.36 score on a scale | Standard Deviation 5.69 |
| Engage-M | Change in Clinically Significant Depressive Symptoms (MADRS) | Week 6 | 18.5 score on a scale | Standard Deviation 5.88 |
| Engage-M | Change in Clinically Significant Depressive Symptoms (MADRS) | Baseline | 21.21 score on a scale | Standard Deviation 5.38 |
| Engage-M | Change in Clinically Significant Depressive Symptoms (MADRS) | Week 9 | 15.86 score on a scale | Standard Deviation 6.78 |
| Wellness in Mind and Body (W-MH) | Change in Clinically Significant Depressive Symptoms (MADRS) | Baseline | 21 score on a scale | Standard Deviation 3.85 |
| Wellness in Mind and Body (W-MH) | Change in Clinically Significant Depressive Symptoms (MADRS) | Week 12 | 13.21 score on a scale | Standard Deviation 6.25 |
| Wellness in Mind and Body (W-MH) | Change in Clinically Significant Depressive Symptoms (MADRS) | Week 9 | 15.86 score on a scale | Standard Deviation 4.38 |
| Wellness in Mind and Body (W-MH) | Change in Clinically Significant Depressive Symptoms (MADRS) | Week 6 | 15.77 score on a scale | Standard Deviation 6.18 |
Comparison: Week 12p-value: 0.3195% CI: [-2.09, 6.39]t-test, 2 sided
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.
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.
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engage-M | Change in Assessment of Quality of Life (WHO-QOL) | Baseline - Domain 1 | 22.14 score on a scale | Standard Deviation 4.1 |
| Engage-M | Change in Assessment of Quality of Life (WHO-QOL) | Baseline - Domain 2 | 17.81 score on a scale | Standard Deviation 3.43 |
| Engage-M | Change in Assessment of Quality of Life (WHO-QOL) | Baseline - Domain 3 | 8.30 score on a scale | Standard Deviation 2.62 |
| Engage-M | Change in Assessment of Quality of Life (WHO-QOL) | Baseline - Domain 4 | 29.00 score on a scale | Standard Deviation 4.01 |
| Engage-M | Change in Assessment of Quality of Life (WHO-QOL) | Week 6 - Domain 1 | 22.16 score on a scale | Standard Deviation 3.78 |
| Engage-M | Change in Assessment of Quality of Life (WHO-QOL) | Week 6 - Domain 2 | 18.00 score on a scale | Standard Deviation 3.35 |
| Engage-M | Change in Assessment of Quality of Life (WHO-QOL) | Week 6 - Domain 3 | 8.92 score on a scale | Standard Deviation 2.14 |
| Engage-M | Change in Assessment of Quality of Life (WHO-QOL) | Week 6 - Domain 4 | 31.42 score on a scale | Standard Deviation 4.34 |
| Engage-M | Change in Assessment of Quality of Life (WHO-QOL) | Week 9 - Domain 1 | 22.67 score on a scale | Standard Deviation 2.37 |
| Engage-M | Change in Assessment of Quality of Life (WHO-QOL) | Week 9 - Domain 2 | 18.19 score on a scale | Standard Deviation 3.28 |
| Engage-M | Change in Assessment of Quality of Life (WHO-QOL) | Week 9 - Domain 3 | 9.08 score on a scale | Standard Deviation 2.68 |
| Engage-M | Change in Assessment of Quality of Life (WHO-QOL) | Week 9 - Domain 4 | 31.43 score on a scale | Standard Deviation 4.04 |
| Engage-M | Change in Assessment of Quality of Life (WHO-QOL) | Week 12 - Domain 1 | 20.68 score on a scale | Standard Deviation 4.19 |
| Engage-M | Change in Assessment of Quality of Life (WHO-QOL) | Week 12 - Domain 2 | 17.59 score on a scale | Standard Deviation 3.84 |
| Engage-M | Change in Assessment of Quality of Life (WHO-QOL) | Week 12 - Domain 3 | 8.69 score on a scale | Standard Deviation 2.55 |
| Engage-M | Change in Assessment of Quality of Life (WHO-QOL) | Week 12 - Domain 4 | 30.18 score on a scale | Standard Deviation 4.69 |
| Wellness in Mind and Body (W-MH) | Change in Assessment of Quality of Life (WHO-QOL) | Week 12 - Domain 4 | 30.23 score on a scale | Standard Deviation 5.33 |
| Wellness in Mind and Body (W-MH) | Change in Assessment of Quality of Life (WHO-QOL) | Baseline - Domain 1 | 20.87 score on a scale | Standard Deviation 3.23 |
| Wellness in Mind and Body (W-MH) | Change in Assessment of Quality of Life (WHO-QOL) | Week 9 - Domain 1 | 22.08 score on a scale | Standard Deviation 4.42 |
| Wellness in Mind and Body (W-MH) | Change in Assessment of Quality of Life (WHO-QOL) | Baseline - Domain 2 | 17.50 score on a scale | Standard Deviation 3.03 |
| Wellness in Mind and Body (W-MH) | Change in Assessment of Quality of Life (WHO-QOL) | Week 12 - Domain 1 | 22.15 score on a scale | Standard Deviation 3.76 |
| Wellness in Mind and Body (W-MH) | Change in Assessment of Quality of Life (WHO-QOL) | Baseline - Domain 3 | 9.36 score on a scale | Standard Deviation 1.43 |
| Wellness in Mind and Body (W-MH) | Change in Assessment of Quality of Life (WHO-QOL) | Week 9 - Domain 2 | 19.08 score on a scale | Standard Deviation 4.41 |
| Wellness in Mind and Body (W-MH) | Change in Assessment of Quality of Life (WHO-QOL) | Baseline - Domain 4 | 30.80 score on a scale | Standard Deviation 3.76 |
| Wellness in Mind and Body (W-MH) | Change in Assessment of Quality of Life (WHO-QOL) | Week 12 - Domain 3 | 10.27 score on a scale | Standard Deviation 1.27 |
| Wellness in Mind and Body (W-MH) | Change in Assessment of Quality of Life (WHO-QOL) | Week 6 - Domain 1 | 21.00 score on a scale | Standard Deviation 3.57 |
| Wellness in Mind and Body (W-MH) | Change in Assessment of Quality of Life (WHO-QOL) | Week 9 - Domain 3 | 10.00 score on a scale | Standard Deviation 1.49 |
| Wellness in Mind and Body (W-MH) | Change in Assessment of Quality of Life (WHO-QOL) | Week 6 - Domain 2 | 18.83 score on a scale | Standard Deviation 2.52 |
| Wellness in Mind and Body (W-MH) | Change in Assessment of Quality of Life (WHO-QOL) | Week 12 - Domain 2 | 18.46 score on a scale | Standard Deviation 3.67 |
| Wellness in Mind and Body (W-MH) | Change in Assessment of Quality of Life (WHO-QOL) | Week 6 - Domain 3 | 9.00 score on a scale | Standard Deviation 2.49 |
| Wellness in Mind and Body (W-MH) | Change in Assessment of Quality of Life (WHO-QOL) | Week 9 - Domain 4 | 29.69 score on a scale | Standard Deviation 4.52 |
| Wellness in Mind and Body (W-MH) | Change in Assessment of Quality of Life (WHO-QOL) | Week 6 - Domain 4 | 30.25 score on a scale | Standard Deviation 5.05 |
Comparison: Domain #1, Week 12p-value: 0.2895% CI: [-4.22, 1.28]t-test, 2 sided
Comparison: Domain #2, Week 12p-value: 0.595% CI: [-3.48, 1.74]t-test, 2 sided
Comparison: Domain #3, Week 12p-value: 0.0295% CI: [-2.88, -0.28]t-test, 2 sided
Comparison: Domain 4, Week 12p-value: 0.9895% CI: [-3.63, 3.53]t-test, 2 sided
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. 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
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engage-M | Change in Satisfaction With Study Intervention (CSQ) | Week 6 - #1 | 2.80 score on a scale | Standard Deviation 1.06 |
| Engage-M | Change in Satisfaction With Study Intervention (CSQ) | Week 6 - #2 | 3.35 score on a scale | Standard Deviation 0.88 |
| Engage-M | Change in Satisfaction With Study Intervention (CSQ) | Week 6 - #3 | 3.50 score on a scale | Standard Deviation 0.76 |
| Engage-M | Change in Satisfaction With Study Intervention (CSQ) | Week 9 - #1 | 3.00 score on a scale | Standard Deviation 1 |
| Engage-M | Change in Satisfaction With Study Intervention (CSQ) | Week 9 - #2 | 3.57 score on a scale | Standard Deviation 0.75 |
| Engage-M | Change in Satisfaction With Study Intervention (CSQ) | Week 9 - #3 | 3.70 score on a scale | Standard Deviation 0.57 |
| Engage-M | Change in Satisfaction With Study Intervention (CSQ) | Week 12 - #1 | 2.68 score on a scale | Standard Deviation 0.95 |
| Engage-M | Change in Satisfaction With Study Intervention (CSQ) | Week 12 - #2 | 3.18 score on a scale | Standard Deviation 0.8 |
| Engage-M | Change in Satisfaction With Study Intervention (CSQ) | Week 12 - #3 | 3.68 score on a scale | Standard Deviation 0.72 |
| Wellness in Mind and Body (W-MH) | Change in Satisfaction With Study Intervention (CSQ) | Week 9 - #1 | 2.43 score on a scale | Standard Deviation 0.65 |
| Wellness in Mind and Body (W-MH) | Change in Satisfaction With Study Intervention (CSQ) | Week 6 - #1 | 2.23 score on a scale | Standard Deviation 0.73 |
| Wellness in Mind and Body (W-MH) | Change in Satisfaction With Study Intervention (CSQ) | Week 9 - #3 | 3.50 score on a scale | Standard Deviation 0.76 |
| Wellness in Mind and Body (W-MH) | Change in Satisfaction With Study Intervention (CSQ) | Week 6 - #2 | 2.77 score on a scale | Standard Deviation 0.93 |
| Wellness in Mind and Body (W-MH) | Change in Satisfaction With Study Intervention (CSQ) | Week 12 - #2 | 3.36 score on a scale | Standard Deviation 0.63 |
| Wellness in Mind and Body (W-MH) | Change in Satisfaction With Study Intervention (CSQ) | Week 6 - #3 | 3.69 score on a scale | Standard Deviation 0.48 |
| Wellness in Mind and Body (W-MH) | Change in Satisfaction With Study Intervention (CSQ) | Week 12 - #1 | 2.71 score on a scale | Standard Deviation 0.83 |
| Wellness in Mind and Body (W-MH) | Change in Satisfaction With Study Intervention (CSQ) | Week 12 - #3 | 3.50 score on a scale | Standard Deviation 0.76 |
| Wellness in Mind and Body (W-MH) | Change in Satisfaction With Study Intervention (CSQ) | Week 9 - #2 | 3.14 score on a scale | Standard Deviation 0.77 |
Comparison: Domain #1, Week 12p-value: 0.9295% CI: [-0.64, 0.58]t-test, 2 sided
Comparison: Domain #2, Week 12p-value: 0.4895% CI: [-0.69, 0.33]t-test, 2 sided
p-value: 0.4895% CI: [-0.33, 0.69]t-test, 2 sided