NCT04621877 · University of Washington
Lay-Delivered Behavioral Activation in Senior Centers
What this study is about
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).
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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;
- Inability to speak and read English or Spanish Clinician Participants (anticipated enrollment: 36) Inclusion Criteria
- Master's degree in social work, counseling, marriage/family, or other clinical mental health degree
- English or Spanish 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 or Non-Spanish 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
Where
- Brandon, Florida
- Gibsonton, Florida
- Ruskin, Florida
- Tampa, Florida
- Brooklyn, New York
- New York, New York
- Enumclaw, Washington
- Seattle, Washington
- Tacoma, Washington
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 15, 2024 · Source of record for eligibility and locations