Lay-Delivered Behavioral Activation in Senior Centers

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.

Study Overview

• Status: Recruiting
• Conditions: Depression
• Intervention / Treatment: Behavioral: Volunteer-delivered Behavioral Activation; Behavioral: Master's level clinician-delivered Behavioral Activation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 288
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brittany Mosser; Phone Number: 206-616-2129; Email: dmfb@uw.edu
• Study Contact Backup: Name: Dylan Fisher; Phone Number: 206-616-2129; Email: dmfb@uw.edu

Study Locations

• United States
  • Florida
    • Brandon, Florida, United States, 33510
      • Recruiting
      • Brandon Senior Center
      • Contact: Mary Goldsworthy; Phone Number: 813-974-3576; Email: domorefeelbetter@usf.edu
    • Gibsonton, Florida, United States, 33534
      • Recruiting
      • Gardenville Dining & Activity Center
      • Contact: Mary Goldsworthy; Phone Number: 813-974-3576; Email: domorefeelbetter@usf.edu
    • Ruskin, Florida, United States, 33570
      • Recruiting
      • Ruskin Senior Center
      • Contact: Mary Goldsworthy; Phone Number: 813-974-3576; Email: domorefeelbetter@usf.edu
    • Tampa, Florida, United States, 33604
      • Recruiting
      • JL Young Apartments (Senior Housing)
      • Contact: Mary Goldsworthy; Phone Number: 813-974-3576; Email: domorefeelbetter@usf.edu
    • Tampa, Florida, United States, 33604
      • Recruiting
      • Oaks at Riverview Senior Center
      • Contact: Mary Goldsworthy; Phone Number: 813-974-3576; Email: domorefeelbetter@usf.edu
    • Tampa, Florida, United States, 33619
      • Recruiting
      • Progress Village Senior Center
      • Contact: Mary Goldsworthy; Phone Number: 813-974-3576; Email: domorefeelbetter@usf.edu
    • Tampa, Florida, United States, 33609
      • Recruiting
      • Jewish Towers Senior Housing
      • Contact: Melody Espinosa; Phone Number: 813-396-2758; Email: domorefeelbetter@usf.edu
    • Tampa, Florida, United States, 33615
      • Recruiting
      • Town 'n Country Senior Center
      • Contact: Melody Espinosa; Phone Number: 813-396-2758; Email: domorefeelbetter@usf.edu
  • New York
    • Brooklyn, New York, United States, 11206
      • Active, not recruiting
      • Diana Jones Senior Center
    • New York, New York, United States, 10001
      • Active, not recruiting
      • Edie Windsor SAGE Center
    • New York, New York, United States, 10024
      • Recruiting
      • Goddard Riverside Community Center and NORC
      • Contact: Victoria Micha Weiss; Phone Number: 915-507-7672
    • New York, New York, United States, 10128
      • Active, not recruiting
      • Stanley M. Isaacs Neighborhood Center
    • New York, New York, United States, 11201
      • Recruiting
      • SAGE Center Brooklyn at Stonewall House
      • Contact: Victoria Micha Weiss; Phone Number: 915-507-7672
    • New York, New York, United States, 10011
      • Recruiting
      • Hudson Guild Senior Center
      • Contact: Victoria Micha Weiss; Phone Number: 915-507-7672
    • New York, New York, United States, 10023
      • Recruiting
      • Lincoln Square Senior Center
      • Contact: Victoria Micha Weiss; Phone Number: 915-507-7672
    • New York, New York, United States, 10029
      • Recruiting
      • Carver Senior Center
      • Contact: Victoria Micha Weiss; Phone Number: 915-507-7672
    • New York, New York, United States, 10034
      • Recruiting
      • Dyckman Senior Center
      • Contact: Victoria Micha Weiss; Phone Number: 915-507-7672
  • Washington
    • Enumclaw, Washington, United States, 98022
      • Recruiting
      • Enumclaw Senior Center
      • Contact: Dylan Fisher; Phone Number: 206-616-2129; Email: dmfb@uw.edu
    • Seattle, Washington, United States, 98103
      • Active, not recruiting
      • Greenwood Senior Center
    • Seattle, Washington, United States, 98118
      • Active, not recruiting
      • Southeast Seattle Senior Center
    • Seattle, Washington, United States, 98116
      • Active, not recruiting
      • West Seattle Senior Center
    • Seattle, Washington, United States, 98122
      • Active, not recruiting
      • GenPride Senior Center
    • Seattle, Washington, United States, 98144
      • Recruiting
      • Casa Latina
      • Contact: Bernardo Martinez; Phone Number: 206-616-2129; Email: dmfb@uw.edu
    • Seattle, Washington, United States, 98144
      • Recruiting
      • Centro de la Raza
      • Contact: Bernardo Martinez; Phone Number: 206-616-2129; Email: dmfb@uw.edu
    • Tacoma, Washington, United States, 98407
      • Recruiting
      • Pt Defiance Senior Center
      • Contact: Dylan Fisher; Phone Number: 206-616-2129; Email: dmfb@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Client Participants (anticipated enrollment: 288)

Inclusion Criteria:

Referral to study (stage 1):

1. Age ≥ 60 years.
2. Attends one of 18 participating Seattle, NYC, or Tampa area senior centers.
3. Patient Health Questionnaire (PHQ-9) score of ≥10 via routine screening.

Research assessment (stage 2):

1. Clinically-assessed HAM-D>14
2. Mini-Mental Status Exam (MMSE) ≥ 24 OR modified Telephone Interview for Cognitive Status (mTICS) ≥ 19
3. Off antidepressants or on a stable dose for 12 weeks.
4. Capacity to provide written consent for both research assessment and the BA intervention.

Client Participants Exclusion Criteria:

1. Current active suicidal ideation.
2. Presence of psychiatric diagnoses other than unipolar, non-psychotic major depression or generalized anxiety disorder by SCID-V (Structure Clinical Interview for DSM-V).
3. Severe or life-threatening medical illness (e.g., end stage organ failure).
4. Inability to speak English or Spanish

Volunteer Participants (anticipated enrollment: 36) Inclusion Criteria

1. Age ≥ 60 years.
2. Attends one of the participating Seattle, NYC, or Tampa-area senior centers.

Volunteer Participants Exclusion Criteria

1. Current major depressive disorder, alcohol or substance abuse, or manic, hypomanic, or psychotic symptoms (SCID-V);
2. Mini-Mental Status Exam (MMSE) ≥ 24 OR modified Telephone Interview for Cognitive Status (mTICS) ≥ 19;
3. Inability to speak and read English or Spanish

Clinician Participants (anticipated enrollment: 36) Inclusion Criteria

1. Master's degree in social work, counseling, marriage/family, or other clinical mental health degree
2. English or Spanish Speaking
3. Capacity to provide consent for all study procedures
4. Willing to audio record study sessions for supervision and evaluation

Clinician Participants Exclusion Criteria

1. Non-English or Non-Spanish speaking
2. Does not hold a Master's degree in social work, counseling, marriage/family, or other clinical mental health degree
3. Unable to provide consent
4. Unwilling to audio record study sessions for supervision and evaluation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Volunteer-delivered Behavioral Activation - "Do More, Feel Better"; "Do More, Feel Better" (DMFB) is a streamlined, simplified version of Behavioral Activation (BA) delivered by lay volunteers to depressed senior center clients.	Behavioral: Volunteer-delivered Behavioral Activation; Behavioral Activation as delivered by trained volunteers
Active Comparator: Master's Level Clinician-delivered Behavioral Activation; Traditional Behavioral Activation (BA) delivered by master's level mental health clinicians	Behavioral: Master's level clinician-delivered Behavioral Activation; Behavioral Activation as delivered by trained master's level clinicians

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH); University of South Florida; Weill Medical College of Cornell University
• Investigators: Principal Investigator: Patrick J Raue, PhD, University of Washington

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2021
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 9, 2020

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: STUDY00011434; R01MH124975 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will deposit participant data into the NIMH informatics infrastructure (e.g., National Data Archive) to enable sharing of clinical research data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No