Recruiting

Behavioral Activation

Sponsor:

University of Washington

Code:

NCT04621877

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Volunteer-delivered Behavioral Activation

Master's level clinician-delivered Behavioral Activation

Study Details

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.

Conditions

Depression

Study ID

NCT04621877

Start date

Jan 27, 2021

Status verified date

Oct, 2024

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Sep 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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 Design

Enrollment

288 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

active comparator: Master's Level Clinician-delivered Behavioral Activation

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

Interventions

Volunteer-delivered Behavioral Activation

Behavioral Activation as delivered by trained volunteers

Master's level clinician-delivered Behavioral Activation

Behavioral Activation as delivered by trained master's level clinicians

Primary outcome measure

  • Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: Change from Baseline HAM-D at 3, 6, 9, 24, and 36 weeks after treatment starts ]
  • Behavioral Activation Scale (BADS) [ Time Frame: Change from Baseline BADS at 3, 6, 9, 24, and 36 weeks after treatment starts ]

Central Contacts and Locations

Central contacts

Locations

Brandon Senior Center

Recruiting

Brandon, Florida, United States, 33510

Contacts

Gardenville Dining & Activity Center

Recruiting

Gibsonton, Florida, United States, 33534

Contacts

Ruskin Senior Center

Recruiting

Ruskin, Florida, United States, 33570

Contacts

JL Young Apartments (Senior Housing)

Recruiting

Tampa, Florida, United States, 33604

Contacts

Oaks at Riverview Senior Center

Recruiting

Tampa, Florida, United States, 33604

Contacts

Jewish Towers Senior Housing

Recruiting

Tampa, Florida, United States, 33609

Contacts

Town 'n Country Senior Center

Recruiting

Tampa, Florida, United States, 33615

Contacts

Progress Village Senior Center

Recruiting

Tampa, Florida, United States, 33619

Contacts

Hudson Guild Senior Center

Recruiting

New York, New York, United States, 10011

Contacts

Victoria Micha Weiss

915-507-7672

Lincoln Square Senior Center

Recruiting

New York, New York, United States, 10023

Contacts

Victoria Micha Weiss

915-507-7672

Goddard Riverside Community Center and NORC

Recruiting

New York, New York, United States, 10024

Contacts

Victoria Micha Weiss

915-507-7672

Carver Senior Center

Recruiting

New York, New York, United States, 10029

Contacts

Victoria Micha Weiss

915-507-7672

Dyckman Senior Center

Recruiting

New York, New York, United States, 10034

Contacts

Victoria Micha Weiss

915-507-7672

SAGE Center Brooklyn at Stonewall House

Recruiting

New York, New York, United States, 11201

Contacts

Victoria Micha Weiss

915-507-7672

Enumclaw Senior Center

Recruiting

Enumclaw, Washington, United States, 98022

Contacts

Casa Latina

Recruiting

Seattle, Washington, United States, 98144

Contacts

Bernardo Martinez

206-616-2129dmfb@uw.edu

Centro de la Raza

Recruiting

Seattle, Washington, United States, 98144

Contacts

Bernardo Martinez

206-616-2129dmfb@uw.edu

Pt Defiance Senior Center

Recruiting

Tacoma, Washington, United States, 98407

Contacts

More Information

Sponsor

University of Washington

Last update posted

Oct 15, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2024-10-15.