Clinical trial NCT04621877: Lay-Delivered Behavioral Activation in Senior Centers
Official title: Lay-Delivered Behavioral Activation in Senior Centers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of South Florida
name: Weill Medical College of Cornell University
First posted: 2020-11-09
Enrollment: 288
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hamilton Rating Scale for Depression (HAM-D)
timeFrame: Change from Baseline HAM-D at 3, 6, 9, 24, and 36 weeks after treatment starts
measure: Behavioral Activation Scale (BADS)
timeFrame: Change from Baseline BADS at 3, 6, 9, 24, and 36 weeks after treatment starts
Secondary outcomes:
measure: World Health Organization Disability Assessment Schedule (WHODAS II)
timeFrame: Change from Baseline WHODAS-II at 3, 6, 9, 24, and 36 weeks after treatment starts
measure: Client Satisfaction with Treatment (CSQ)- 3 Item
timeFrame: Administered at 3, 6, and 9 weeks after treatment starts
Other outcomes:
measure: Intervention Fidelity
timeFrame: Weekly for 9 weeks of treatment
Locations:
city: Brandon
country: United States
facility: Brandon Senior Center
state: Florida
city: Gibsonton
country: United States
facility: Gardenville Dining & Activity Center
state: Florida
city: Ruskin
country: United States
facility: Ruskin Senior Center
state: Florida
city: Tampa
country: United States
facility: JL Young Apartments (Senior Housing)
state: Florida
city: Tampa
country: United States
facility: Oaks at Riverview Senior Center
state: Florida
city: Tampa
country: United States
facility: Jewish Towers Senior Housing
state: Florida
city: Tampa
country: United States
facility: Town 'n Country Senior Center
state: Florida
city: Tampa
country: United States
facility: Progress Village Senior Center
state: Florida
city: Brooklyn
country: United States
facility: Diana Jones Senior Center
state: New York
city: New York
country: United States
facility: Edie Windsor SAGE Center
state: New York
city: New York
country: United States
facility: Hudson Guild Senior Center
state: New York
city: New York
country: United States
facility: Lincoln Square Senior Center
state: New York
city: New York
country: United States
facility: Goddard Riverside Community Center and NORC
state: New York
city: New York
country: United States
facility: Carver Senior Center
state: New York
city: New York
country: United States
facility: Dyckman Senior Center
state: New York
city: New York
country: United States
facility: Stanley M. Isaacs Neighborhood Center
state: New York
city: New York
country: United States
facility: SAGE Center Brooklyn at Stonewall House
state: New York
city: Enumclaw
country: United States
facility: Enumclaw Senior Center
state: Washington
city: Seattle
country: United States
facility: Greenwood Senior Center
state: Washington
city: Seattle
country: United States
facility: West Seattle Senior Center
state: Washington
city: Seattle
country: United States
facility: Southeast Seattle Senior Center
state: Washington
city: Seattle
country: United States
facility: GenPride Senior Center
state: Washington
city: Seattle
country: United States
facility: Casa Latina
state: Washington
city: Seattle
country: United States
facility: Centro de la Raza
state: Washington
city: Tacoma
country: United States
facility: Pt Defiance Senior Center
state: Washington
Study officials:
affiliation: University of Washington
name: Patrick J Raue, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.