search
Back to results

Lay-Delivered Behavioral Activation in Senior Centers

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Volunteer-delivered Behavioral Activation
Master's level clinician-delivered Behavioral Activation
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brandon Senior CenterRecruiting
  • JL Young Apartments (Senior Housing)Recruiting
  • Oaks at Riverview Senior CenterRecruiting
  • Progress Village Senior CenterRecruiting
  • Edie Windsor SAGE Center
  • Goddard Riverside Community Center and NORCRecruiting
  • Stanley M. Isaacs Neighborhood Center
  • SAGE Center Brooklyn at Stonewall HouseRecruiting
  • Greenwood Senior Center
  • West Seattle Senior CenterRecruiting
  • Southeast Seattle Senior Center
  • GenPride Senior CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

Master's Level Clinician-delivered Behavioral Activation

Arm Description

"Do More, Feel Better" (DMFB) is a streamlined, simplified version of Behavioral Activation (BA) delivered by lay volunteers to depressed senior center clients.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

World Health Organization Disability Assessment Schedule (WHODAS II)
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.
Client Satisfaction with Treatment (CSQ)- 3 Item
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.

Full Information

First Posted
November 3, 2020
Last Updated
July 25, 2022
Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH), University of South Florida, Weill Medical College of Cornell University
search

1. Study Identification

Unique Protocol Identification Number
NCT04621877
Brief Title
Lay-Delivered Behavioral Activation in Senior Centers
Official Title
Lay-Delivered Behavioral Activation in Senior Centers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 27, 2021 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH), University of South Florida, Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Volunteer-delivered Behavioral Activation - "Do More, Feel Better"
Arm Type
Experimental
Arm Description
"Do More, Feel Better" (DMFB) is a streamlined, simplified version of Behavioral Activation (BA) delivered by lay volunteers to depressed senior center clients.
Arm Title
Master's Level Clinician-delivered Behavioral Activation
Arm Type
Active Comparator
Arm Description
Traditional Behavioral Activation (BA) delivered by master's level mental health clinicians
Intervention Type
Behavioral
Intervention Name(s)
Volunteer-delivered Behavioral Activation
Intervention Description
Behavioral Activation as delivered by trained volunteers
Intervention Type
Behavioral
Intervention Name(s)
Master's level clinician-delivered Behavioral Activation
Intervention Description
Behavioral Activation as delivered by trained master's level clinicians
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression (HAM-D)
Description
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.
Time Frame
Change from Baseline HAM-D at 3, 6, 9, 24, and 36 weeks after treatment starts
Title
Behavioral Activation Scale (BADS)
Description
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.
Time Frame
Change from Baseline BADS at 3, 6, 9, 24, and 36 weeks after treatment starts
Secondary Outcome Measure Information:
Title
World Health Organization Disability Assessment Schedule (WHODAS II)
Description
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.
Time Frame
Change from Baseline WHODAS-II at 3, 6, 9, 24, and 36 weeks after treatment starts
Title
Client Satisfaction with Treatment (CSQ)- 3 Item
Description
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.
Time Frame
Administered at 3, 6, and 9 weeks after treatment starts
Other Pre-specified Outcome Measures:
Title
Intervention Fidelity
Description
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.
Time Frame
Weekly for 9 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Client Participants (anticipated enrollment: 288) Inclusion Criteria: Referral to study (stage 1): Age ≥ 60 years. Attends one of 18 participating Seattle, NYC, or Tampa 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. Client Participants Exclusion Criteria: 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. Volunteer Participants (anticipated enrollment: 36) Inclusion Criteria Age ≥ 60 years. Attends one of the participating Seattle, NYC, or Tampa-area senior centers. Volunteer Participants Exclusion Criteria 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. Clinician Participants (anticipated enrollment: 36) Inclusion Criteria Master's degree in social work, counseling, marriage/family, or other clinical mental health degree English Speaking Capacity to provide consent for all study procedures Willing to audio record study sessions for supervision and evaluation Clinician Participants Exclusion Criteria Non-English speaking Does not hold a Master's degree in social work, counseling, marriage/family, or other clinical mental health degree Unable to provide consent Unwilling to audio record study sessions for supervision and evaluation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brittany Mosser
Phone
206-543-3350
Email
bmosser@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dylan Fisher
Phone
206-221-7303
Email
dfisher2@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick J Raue, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brandon Senior Center
City
Brandon
State/Province
Florida
ZIP/Postal Code
33510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Goldsworthy
Phone
813-974-3576
Email
domorefeelbetter@usf.edu
Facility Name
JL Young Apartments (Senior Housing)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Goldsworthy
Phone
813-974-3576
Email
domorefeelbetter@usf.edu
Facility Name
Oaks at Riverview Senior Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Goldsworthy
Phone
813-974-3576
Email
domorefeelbetter@usf.edu
Facility Name
Progress Village Senior Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33619
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Goldsworthy
Phone
813-974-3576
Email
domorefeelbetter@usf.edu
Facility Name
Edie Windsor SAGE Center
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Goddard Riverside Community Center and NORC
City
New York
State/Province
New York
ZIP/Postal Code
10024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiana Seresinhe
Phone
844-999-8746
Ext
720
Email
kms4003@med.cornell.edu
Facility Name
Stanley M. Isaacs Neighborhood Center
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
SAGE Center Brooklyn at Stonewall House
City
New York
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiana Seresinhe
Phone
844-999-8746
Ext
720
Email
kms4003@med.cornell.edu
Facility Name
Greenwood Senior Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98103
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
West Seattle Senior Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98116
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dylan Fisher, BA
Phone
206-616-2129
Email
dmfb@uw.edu
Facility Name
Southeast Seattle Senior Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98118
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
GenPride Senior Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dylan Fisher, BA
Phone
206-616-2129
Email
dmfb@uw.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will deposit participant data into the NIMH informatics infrastructure (e.g., National Data Archive) to enable sharing of clinical research data.
Citations:
PubMed Identifier
35998966
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.
Results Reference
derived

Learn more about this trial

Lay-Delivered Behavioral Activation in Senior Centers

We'll reach out to this number within 24 hrs