Lay-Delivered Behavioral Activation in Senior Centers

• Sponsor: University of Washington (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04621877
• Collaborator: National Institute of Mental Health (NIMH) (NIH), University of South Florida (Other), Weill Medical College of Cornell University (Other)
• Enrollment: 288
• Locations: 12
• Arms: 2
• Anticipated Duration (Months): 58.1
• Patients Per Site: 24
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Behavioral: Volunteer-delivered Behavioral Activation; Behavioral: Master's level clinician-delivered Behavioral Activation	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 288 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Lay-Delivered Behavioral Activation in Senior Centers
• Actual Study Start Date: Jan 27, 2021
• Anticipated Primary Completion Date: Sep 30, 2025
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.	Behavioral: Volunteer-delivered Behavioral Activation; Behavioral Activation as delivered by trained volunteers
Active Comparator: Master's Level Clinician-delivered Behavioral Activation Traditional Behavioral Activation (BA) delivered by master's level mental health clinicians	Behavioral: Master's level clinician-delivered Behavioral Activation; Behavioral Activation as delivered by trained master's level clinicians

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. 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.

2. 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.

Other Outcome Measures

1. Intervention Fidelity [Weekly for 9 weeks of treatment]

   The "Do More, Feel Better" and BADT-R fidelity forms will be used by external raters to assess each interventionist's fidelity to the respective treatment modality. Global scores range from 0-6, with scores >3 indicating satisfactory levels of fidelity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 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.

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.

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 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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brandon Senior Center	Brandon	Florida	United States	33510
2	JL Young Apartments (Senior Housing)	Tampa	Florida	United States	33604
3	Oaks at Riverview Senior Center	Tampa	Florida	United States	33604
4	Progress Village Senior Center	Tampa	Florida	United States	33619
5	Edie Windsor SAGE Center	New York	New York	United States	10001
6	Goddard Riverside Community Center and NORC	New York	New York	United States	10024
7	Stanley M. Isaacs Neighborhood Center	New York	New York	United States	10128
8	SAGE Center Brooklyn at Stonewall House	New York	New York	United States	11201
9	Greenwood Senior Center	Seattle	Washington	United States	98103
10	West Seattle Senior Center	Seattle	Washington	United States	98116
11	Southeast Seattle Senior Center	Seattle	Washington	United States	98118
12	GenPride Senior Center	Seattle	Washington	United States	98122

Sponsors and Collaborators

• University of Washington
• National Institute of Mental Health (NIMH)
• University of South Florida
• Weill Medical College of Cornell University

Investigators

• Principal Investigator: Patrick J Raue, PhD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Patrick Raue, Professor, School of Medicine: Psychiatry: Population Health, University of Washington
• ClinicalTrials.gov Identifier: NCT04621877
• Other Study ID Numbers: STUDY00011434; R01MH124975
• First Posted: Nov 9, 2020
• Last Update Posted: Jul 28, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Depression

Study Results

No Results Posted as of Jul 28, 2022