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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH124975 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| University of South Florida | OTHER |
| Weill Medical College of Cornell University | OTHER |
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In response to large numbers of senior center clients who suffer untreated depression and the dearth of geriatric mental health providers, the investigators have simplified Behavioral Activation to be delivered by lay volunteers ("Do More, Feel Better"; DMFB). The focus of Behavioral Activation is to guide clients to reengage in daily pleasant and rewarding activities, and reduce depressive symptoms. If the investigators can show that the lay delivery model has positive impact in comparison to MSW-delivered Behavioral Activation, the investigators will have identified an effective intervention that can be used by a large untapped workforce of older adult volunteers across the nation.
This Collaborative R01 application (UW, Cornell, USF) proposes to conduct an effectiveness trial of lay-delivered Behavioral Activation ("Do More, Feel Better"; DMFB), in comparison to MSW-delivered Behavioral Activation (MSW BA), for depressed (PHQ-9>10 and Ham-D>14) older (60+) senior center clients. The primary aim tests the effectiveness of DMFB, in comparison to MSW BA, on increasing overall activity level (target) and reducing depression symptoms. The investigators will test whether increased activity level predicts greater reduction in depression severity and whether increased activity's impact on depression is non-inferior across conditions. Secondarily, the investigators will test hypotheses associated with overall functioning, satisfaction with treatment, and client-level moderators. Lastly the investigators will explore longer-term client outcomes, delivery cost, and preparing for sustainability by exploring client, provider, and center factors related to intervention fidelity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volunteer-delivered Behavioral Activation - "Do More, Feel Better" | Experimental | "Do More, Feel Better" (DMFB) is a streamlined, simplified version of Behavioral Activation (BA) delivered by lay volunteers to depressed senior center clients. |
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| Master's Level Clinician-delivered Behavioral Activation | Active Comparator | Traditional Behavioral Activation (BA) delivered by master's level mental health clinicians |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volunteer-delivered Behavioral Activation | Behavioral | Behavioral Activation as delivered by trained volunteers |
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| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Rating Scale for Depression (HAM-D) | The HAM-D will be used as measure of depressive symptom severity. The HAM-D is a clinically administered measure and has been validated in a variety of psychiatric populations. | Change from Baseline HAM-D at 3, 6, 9, 24, and 36 weeks after treatment starts |
| Behavioral Activation Scale (BADS) | The BADS will be used as the primary target measure, and yields a total score reflecting level of engagement in reinforcing activities. The BADS has shown good psychometric properties; studies have validated the BADS as a mechanism by which behavioral activation interventions reduces depression. | Change from Baseline BADS at 3, 6, 9, 24, and 36 weeks after treatment starts |
| Measure | Description | Time Frame |
|---|---|---|
| World Health Organization Disability Assessment Schedule (WHODAS II) | The World Health Organization Disability Assessment Schedule II (WHODAS II)-12 item form will be used to assess overall functioning. This instrument is cross-culturally applicable and treats all disorders at parity when determining level of functioning. The WHODAS II assesses 6 domains: a. understanding and communicating; b. getting around; c. self-care; d. getting along with others; e. household and work activities; and f. participation in society. Each domain has factor loading of at least 0.70 and the items also load on a general disability factor which will be used in this proposal. |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Fidelity | The "Do More, Feel Better" and BADT-R fidelity forms will be used by external raters to assess each interventionist's fidelity to the respective treatment modality. Global scores range from 0-6, with scores >3 indicating satisfactory levels of fidelity. | Weekly for 9 weeks of treatment |
Client Participants (anticipated enrollment: 288)
Inclusion Criteria:
Referral to study (stage 1):
Research assessment (stage 2):
Client Participants Exclusion Criteria:
Volunteer Participants (anticipated enrollment: 36) Inclusion Criteria
Volunteer Participants Exclusion Criteria
Clinician Participants (anticipated enrollment: 36) Inclusion Criteria
Clinician Participants Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brittany Mosser | Contact | 206-616-2129 | dmfb@uw.edu | |
| Dylan Fisher | Contact | 206-616-2129 | dmfb@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Patrick J Raue, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brandon Senior Center | Recruiting | Brandon | Florida | 33510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35998966 | Derived | Raue PJ, Sirey JA, Gum A, Hawrilenko M, Fisher DM. Protocol for a collaborative randomised effectiveness trial of lay-delivered versus clinician-delivered behavioural activation in senior centres. BMJ Open. 2022 Aug 23;12(8):e066497. doi: 10.1136/bmjopen-2022-066497. |
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We will deposit participant data into the NIMH informatics infrastructure (e.g., National Data Archive) to enable sharing of clinical research data.
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| Master's level clinician-delivered Behavioral Activation | Behavioral | Behavioral Activation as delivered by trained master's level clinicians |
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| Change from Baseline WHODAS-II at 3, 6, 9, 24, and 36 weeks after treatment starts |
| Client Satisfaction with Treatment (CSQ)- 3 Item | The 3-item version of the Client Satisfaction Questionnaire (CSQ) will be used as a patient self-report measure of satisfaction with study interventions. The CSQ has high internal consistency and successfully distinguishes degrees of satisfaction even at the high end. | Administered at 3, 6, and 9 weeks after treatment starts |
| Gardenville Dining & Activity Center | Recruiting | Gibsonton | Florida | 33534 | United States |
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| Ruskin Senior Center | Recruiting | Ruskin | Florida | 33570 | United States |
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| JL Young Apartments (Senior Housing) | Recruiting | Tampa | Florida | 33604 | United States |
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| Oaks at Riverview Senior Center | Recruiting | Tampa | Florida | 33604 | United States |
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| Jewish Towers Senior Housing | Recruiting | Tampa | Florida | 33609 | United States |
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| Town 'n Country Senior Center | Recruiting | Tampa | Florida | 33615 | United States |
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| Progress Village Senior Center | Recruiting | Tampa | Florida | 33619 | United States |
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| Diana Jones Senior Center | Active, not recruiting | Brooklyn | New York | 11206 | United States |
| Edie Windsor SAGE Center | Active, not recruiting | New York | New York | 10001 | United States |
| Hudson Guild Senior Center | Recruiting | New York | New York | 10011 | United States |
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| Lincoln Square Senior Center | Recruiting | New York | New York | 10023 | United States |
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| Goddard Riverside Community Center and NORC | Recruiting | New York | New York | 10024 | United States |
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| Carver Senior Center | Recruiting | New York | New York | 10029 | United States |
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| Dyckman Senior Center | Recruiting | New York | New York | 10034 | United States |
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| Stanley M. Isaacs Neighborhood Center | Active, not recruiting | New York | New York | 10128 | United States |
| SAGE Center Brooklyn at Stonewall House | Recruiting | New York | New York | 11201 | United States |
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| Enumclaw Senior Center | Recruiting | Enumclaw | Washington | 98022 | United States |
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| Greenwood Senior Center | Active, not recruiting | Seattle | Washington | 98103 | United States |
| West Seattle Senior Center | Active, not recruiting | Seattle | Washington | 98116 | United States |
| Southeast Seattle Senior Center | Active, not recruiting | Seattle | Washington | 98118 | United States |
| GenPride Senior Center | Active, not recruiting | Seattle | Washington | 98122 | United States |
| Casa Latina | Recruiting | Seattle | Washington | 98144 | United States |
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| Centro de la Raza | Recruiting | Seattle | Washington | 98144 | United States |
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| Pt Defiance Senior Center | Recruiting | Tacoma | Washington | 98407 | United States |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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