Lay-Delivered Behavioral Activation in Senior Centers

Not Applicable

Recruiting

• Conditions: Depression
• Interventions: Behavioral: Master's level clinician-delivered Behavioral Activation; Behavioral: Volunteer-delivered Behavioral Activation

• Registration Number: NCT04621877
• Lead Sponsor: University of Washington

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-09
• Study Start: 2021-01-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Master's Level Clinician-delivered Behavioral Activation	Master's level clinician-delivered Behavioral Activation	Traditional Behavioral Activation (BA) delivered by master's level mental health clinicians
Volunteer-delivered Behavioral Activation - "Do More, Feel Better"	Volunteer-delivered Behavioral Activation	"Do More, Feel Better" (DMFB) is a streamlined, simplified version of Behavioral Activation (BA) delivered by lay volunteers to depressed senior center clients.

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for Depression (HAM-D)	Change from Baseline HAM-D at 3, 6, 9, 24, and 36 weeks after treatment starts	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.
Behavioral Activation Scale (BADS)	Change from Baseline BADS at 3, 6, 9, 24, and 36 weeks after treatment starts	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.

Secondary Outcome Measures

Name	Time	Method
Client Satisfaction with Treatment (CSQ)- 3 Item	Administered at 3, 6, and 9 weeks after treatment starts	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.
World Health Organization Disability Assessment Schedule (WHODAS II)	Change from Baseline WHODAS-II at 3, 6, 9, 24, and 36 weeks after treatment starts	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.

Trial Locations

Locations (25)

Gardenville Dining & Activity Center; 🇺🇸 Gibsonton, Florida, United States

Ruskin Senior Center; 🇺🇸 Ruskin, Florida, United States

Jewish Towers Senior Housing; 🇺🇸 Tampa, Florida, United States

Town 'n Country Senior Center; 🇺🇸 Tampa, Florida, United States

Diana Jones Senior Center; 🇺🇸 Brooklyn, New York, United States

Hudson Guild Senior Center; 🇺🇸 New York, New York, United States

Lincoln Square Senior Center; 🇺🇸 New York, New York, United States

Carver Senior Center; 🇺🇸 New York, New York, United States

Dyckman Senior Center; 🇺🇸 New York, New York, United States

Enumclaw Senior Center; 🇺🇸 Enumclaw, Washington, United States

Casa Latina; 🇺🇸 Seattle, Washington, United States

Centro de la Raza; 🇺🇸 Seattle, Washington, United States

Pt Defiance Senior Center; 🇺🇸 Tacoma, Washington, United States

Brandon Senior Center; 🇺🇸 Brandon, Florida, United States

JL Young Apartments (Senior Housing); 🇺🇸 Tampa, Florida, United States

Oaks at Riverview Senior Center; 🇺🇸 Tampa, Florida, United States

Progress Village Senior Center; 🇺🇸 Tampa, Florida, United States

Edie Windsor SAGE Center; 🇺🇸 New York, New York, United States

Goddard Riverside Community Center and NORC; 🇺🇸 New York, New York, United States

Stanley M. Isaacs Neighborhood Center; 🇺🇸 New York, New York, United States

SAGE Center Brooklyn at Stonewall House; 🇺🇸 New York, New York, United States

Greenwood Senior Center; 🇺🇸 Seattle, Washington, United States

West Seattle Senior Center; 🇺🇸 Seattle, Washington, United States

Southeast Seattle Senior Center; 🇺🇸 Seattle, Washington, United States

GenPride Senior Center; 🇺🇸 Seattle, Washington, United States