Lay-Delivered Behavioral Activation in Senior Centers

NCT ID: NCT04621877

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-27

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Volunteer-delivered Behavioral Activation

Intervention Type BEHAVIORAL

Behavioral Activation as delivered by trained volunteers

Master's Level Clinician-delivered Behavioral Activation

Traditional Behavioral Activation (BA) delivered by master's level mental health clinicians

Group Type ACTIVE_COMPARATOR

Master's level clinician-delivered Behavioral Activation

Intervention Type BEHAVIORAL

Behavioral Activation as delivered by trained master's level clinicians

Interventions

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Volunteer-delivered Behavioral Activation

Behavioral Activation as delivered by trained volunteers

Intervention Type BEHAVIORAL

Master's level clinician-delivered Behavioral Activation

Behavioral Activation as delivered by trained master's level clinicians

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.


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


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

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


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


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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Patrick Raue

Professor, School of Medicine: Psychiatry: Population Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrick J Raue, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Brandon Senior Center

Brandon, Florida, United States

Site Status RECRUITING

Gardenville Dining & Activity Center

Gibsonton, Florida, United States

Site Status RECRUITING

Ruskin Senior Center

Ruskin, Florida, United States

Site Status RECRUITING

JL Young Apartments (Senior Housing)

Tampa, Florida, United States

Site Status RECRUITING

Oaks at Riverview Senior Center

Tampa, Florida, United States

Site Status RECRUITING

Jewish Towers Senior Housing

Tampa, Florida, United States

Site Status RECRUITING

Town 'n Country Senior Center

Tampa, Florida, United States

Site Status RECRUITING

Progress Village Senior Center

Tampa, Florida, United States

Site Status RECRUITING

Diana Jones Senior Center

Brooklyn, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Edie Windsor SAGE Center

New York, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Hudson Guild Senior Center

New York, New York, United States

Site Status RECRUITING

Lincoln Square Senior Center

New York, New York, United States

Site Status RECRUITING

Goddard Riverside Community Center and NORC

New York, New York, United States

Site Status RECRUITING

Carver Senior Center

New York, New York, United States

Site Status RECRUITING

Dyckman Senior Center

New York, New York, United States

Site Status RECRUITING

Stanley M. Isaacs Neighborhood Center

New York, New York, United States

Site Status ACTIVE_NOT_RECRUITING

SAGE Center Brooklyn at Stonewall House

New York, New York, United States

Site Status RECRUITING

Enumclaw Senior Center

Enumclaw, Washington, United States

Site Status RECRUITING

Greenwood Senior Center

Seattle, Washington, United States

Site Status ACTIVE_NOT_RECRUITING

West Seattle Senior Center

Seattle, Washington, United States

Site Status ACTIVE_NOT_RECRUITING

Southeast Seattle Senior Center

Seattle, Washington, United States

Site Status ACTIVE_NOT_RECRUITING

GenPride Senior Center

Seattle, Washington, United States

Site Status ACTIVE_NOT_RECRUITING

Casa Latina

Seattle, Washington, United States

Site Status RECRUITING

Centro de la Raza

Seattle, Washington, United States

Site Status RECRUITING

Pt Defiance Senior Center

Tacoma, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Brittany Mosser

Role: CONTACT

206-616-2129

Dylan Fisher

Role: CONTACT

206-616-2129

Facility Contacts

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Mary Goldsworthy

Role: primary

813-974-3576

Mary Goldsworthy

Role: primary

813-974-3576

Mary Goldsworthy

Role: primary

813-974-3576

Mary Goldsworthy

Role: primary

813-974-3576

Mary Goldsworthy

Role: primary

813-974-3576

Melody Espinosa

Role: primary

813-396-2758

Melody Espinosa

Role: primary

813-396-2758

Mary Goldsworthy

Role: primary

813-974-3576

Victoria Micha Weiss

Role: primary

915-507-7672

Victoria Micha Weiss

Role: primary

915-507-7672

Victoria Micha Weiss

Role: primary

915-507-7672

Victoria Micha Weiss

Role: primary

915-507-7672

Victoria Micha Weiss

Role: primary

915-507-7672

Victoria Micha Weiss

Role: primary

915-507-7672

Dylan Fisher

Role: primary

206-616-2129

Bernardo Martinez

Role: primary

206-616-2129

Bernardo Martinez

Role: primary

206-616-2129

Dylan Fisher

Role: primary

206-616-2129

References

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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.

Reference Type DERIVED
PMID: 35998966 (View on PubMed)

Other Identifiers

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R01MH124975

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00011434

Identifier Type: -

Identifier Source: org_study_id

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