NCT04621877

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
288

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable depression

Geographic Reach
1 country

25 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 27, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

4.7 years

First QC Date

November 3, 2020

Last Update Submit

October 10, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • World Health Organization Disability Assessment Schedule (WHODAS II)

    Change from Baseline WHODAS-II at 3, 6, 9, 24, and 36 weeks after treatment starts

  • Client Satisfaction with Treatment (CSQ)- 3 Item

    Administered at 3, 6, and 9 weeks after treatment starts

Other Outcomes (1)

  • Intervention Fidelity

    Weekly for 9 weeks of treatment

Study Arms (2)

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.

Behavioral: Volunteer-delivered Behavioral Activation

Master's Level Clinician-delivered Behavioral Activation

ACTIVE COMPARATOR

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

Behavioral: Master's level clinician-delivered Behavioral Activation

Interventions

Behavioral Activation as delivered by trained volunteers

Volunteer-delivered Behavioral Activation - "Do More, Feel Better"

Behavioral Activation as delivered by trained master's level clinicians

Master's Level Clinician-delivered Behavioral Activation

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Referral to study (stage 1):
  • Age ≥ 60 years.
  • Attends one of 18 participating Seattle, NYC, or Tampa area senior centers.
  • Patient Health Questionnaire (PHQ-9) score of ≥10 via routine screening.
  • Research assessment (stage 2):
  • Clinically-assessed HAM-D\>14
  • Mini-Mental Status Exam (MMSE) ≥ 24 OR modified Telephone Interview for Cognitive Status (mTICS) ≥ 19
  • Off antidepressants or on a stable dose for 12 weeks.
  • Capacity to provide written consent for both research assessment and the BA intervention.

You may not qualify if:

  • Current active suicidal ideation.
  • Presence of psychiatric diagnoses other than unipolar, non-psychotic major depression or generalized anxiety disorder by SCID-V (Structure Clinical Interview for DSM-V).
  • Severe or life-threatening medical illness (e.g., end stage organ failure).
  • Inability to speak English or Spanish
  • Age ≥ 60 years.
  • Attends one of the participating Seattle, NYC, or Tampa-area senior centers.
  • Current major depressive disorder, alcohol or substance abuse, or manic, hypomanic, or psychotic symptoms (SCID-V);
  • Mini-Mental Status Exam (MMSE) ≥ 24 OR modified Telephone Interview for Cognitive Status (mTICS) ≥ 19;
  • Inability to speak and read English or Spanish
  • Master's degree in social work, counseling, marriage/family, or other clinical mental health degree
  • English or Spanish Speaking
  • Capacity to provide consent for all study procedures
  • Willing to audio record study sessions for supervision and evaluation
  • Non-English or Non-Spanish speaking
  • Does not hold a Master's degree in social work, counseling, marriage/family, or other clinical mental health degree
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Brandon Senior Center

Brandon, Florida, 33510, United States

RECRUITING

Gardenville Dining & Activity Center

Gibsonton, Florida, 33534, United States

RECRUITING

Ruskin Senior Center

Ruskin, Florida, 33570, United States

RECRUITING

JL Young Apartments (Senior Housing)

Tampa, Florida, 33604, United States

RECRUITING

Oaks at Riverview Senior Center

Tampa, Florida, 33604, United States

RECRUITING

Jewish Towers Senior Housing

Tampa, Florida, 33609, United States

RECRUITING

Town 'n Country Senior Center

Tampa, Florida, 33615, United States

RECRUITING

Progress Village Senior Center

Tampa, Florida, 33619, United States

RECRUITING

Diana Jones Senior Center

Brooklyn, New York, 11206, United States

ACTIVE NOT RECRUITING

Edie Windsor SAGE Center

New York, New York, 10001, United States

ACTIVE NOT RECRUITING

Hudson Guild Senior Center

New York, New York, 10011, United States

RECRUITING

Lincoln Square Senior Center

New York, New York, 10023, United States

RECRUITING

Goddard Riverside Community Center and NORC

New York, New York, 10024, United States

RECRUITING

Carver Senior Center

New York, New York, 10029, United States

RECRUITING

Dyckman Senior Center

New York, New York, 10034, United States

RECRUITING

Stanley M. Isaacs Neighborhood Center

New York, New York, 10128, United States

ACTIVE NOT RECRUITING

SAGE Center Brooklyn at Stonewall House

New York, New York, 11201, United States

RECRUITING

Enumclaw Senior Center

Enumclaw, Washington, 98022, United States

RECRUITING

Greenwood Senior Center

Seattle, Washington, 98103, United States

ACTIVE NOT RECRUITING

West Seattle Senior Center

Seattle, Washington, 98116, United States

ACTIVE NOT RECRUITING

Southeast Seattle Senior Center

Seattle, Washington, 98118, United States

ACTIVE NOT RECRUITING

GenPride Senior Center

Seattle, Washington, 98122, United States

ACTIVE NOT RECRUITING

Casa Latina

Seattle, Washington, 98144, United States

RECRUITING

Centro de la Raza

Seattle, Washington, 98144, United States

RECRUITING

Pt Defiance Senior Center

Tacoma, Washington, 98407, United States

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Patrick J Raue, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brittany Mosser

CONTACT

Dylan Fisher

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, School of Medicine: Psychiatry: Population Health

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 9, 2020

Study Start

January 27, 2021

Primary Completion

September 30, 2025

Study Completion

December 1, 2025

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

We will deposit participant data into the NIMH informatics infrastructure (e.g., National Data Archive) to enable sharing of clinical research data.

Locations