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Lay-Delivered Behavioral Activation in Senior Centers

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ClinicalTrials.gov Identifier: NCT04621877
Recruitment Status : Recruiting
First Posted : November 9, 2020
Last Update Posted : March 15, 2021
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of South Florida
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Patrick Raue, University of Washington

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 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 : February 10, 2021
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 ]
    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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Client Participants 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04621877


Contacts
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Contact: Brittany Mosser 206-543-3350 bmosser@uw.edu
Contact: Dylan Fisher 206-221-7303 dfisher2@uw.edu

Locations
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United States, Washington
Greenwood Senior Center Recruiting
Seattle, Washington, United States, 98103
Contact: Dylan Fisher, BA    206-616-2129    dmfb@uw.edu   
Southeast Seattle Senior Center Recruiting
Seattle, Washington, United States, 98118
Contact: Dylan Fisher, BA    206-616-2129    dmfb@uw.edu   
Sponsors and Collaborators
University of Washington
National Institute of Mental Health (NIMH)
University of South Florida
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Patrick J Raue, PhD University of Washington
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Responsible Party: Patrick Raue, Professor, School of Medicine: Psychiatry: Population Health, University of Washington
ClinicalTrials.gov Identifier: NCT04621877    
Other Study ID Numbers: STUDY00011434
R01MH124975 ( U.S. NIH Grant/Contract )
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms