NCT04621877 Lay-Delivered Behavioral Activation in Senior Centers
| NCT ID | NCT04621877 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 288 participants |
| Start Date | 2021-01-27 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 288 participants in total. It began in 2021-01-27 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Patrick J Raue, PhD
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT04621877 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04621877 currently recruiting?
Yes, NCT04621877 is actively recruiting participants. Contact the research team at dmfb@uw.edu for enrollment information.
Where is the NCT04621877 trial being conducted?
This trial is being conducted at Brandon, United States, Gibsonton, United States, Ruskin, United States, Tampa, United States and 11 additional locations.
Who is sponsoring the NCT04621877 clinical trial?
NCT04621877 is sponsored by University of Washington. The principal investigator is Patrick J Raue, PhD at University of Washington. The trial plans to enroll 288 participants.
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