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Clinical Trials/NCT04621877
NCT04621877
Recruiting
Not Applicable

Lay-Delivered Behavioral Activation in Senior Centers

University of Washington25 sites in 1 country288 target enrollmentJanuary 27, 2021
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
University of Washington
Enrollment
288
Locations
25
Primary Endpoint
Hamilton Rating Scale for Depression (HAM-D)
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 27, 2021
End Date
December 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Patrick Raue

Professor, School of Medicine: Psychiatry: Population Health

University of Washington

Eligibility Criteria

Inclusion Criteria

  • 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.
  • 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 or Spanish
  • 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;

Outcomes

Primary Outcomes

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.

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 Outcomes

  • Client Satisfaction with Treatment (CSQ)- 3 Item(Administered at 3, 6, and 9 weeks after treatment starts)
  • World Health Organization Disability Assessment Schedule (WHODAS II)(Change from Baseline WHODAS-II at 3, 6, 9, 24, and 36 weeks after treatment starts)

Study Sites (25)

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