Volunteer-delivered Behavioral Activation
BehavioralBehavioral Activation as delivered by trained volunteers
NCT Number: NCT04621877
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.
Interested in participating?
Request Info60 year and older
All sexes
Interventional
Not applicable
Brandon Senior Center, Brandon, Florida, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Client Participants (anticipated enrollment: 288)
Inclusion criteria
Referral to study (stage 1):
Research assessment (stage 2):
Client Participants Exclusion Criteria:
Volunteer Participants (anticipated enrollment: 36) Inclusion Criteria
Volunteer Participants Exclusion Criteria
Clinician Participants (anticipated enrollment: 36) Inclusion Criteria
Clinician Participants Exclusion Criteria
Behavioral Activation as delivered by trained volunteers
Behavioral Activation as delivered by trained master's level clinicians
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Brittany Mosser
CONTACT
Dylan Fisher
CONTACT
University of Washington
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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