Lay-Delivered Behavioral Activation in Senior Centers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Lay-Delivered Behavioral Activation in Senior Centers

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Volunteer-delivered Behavioral Activation
* Behavioral: Master's level clinician-delivered Behavioral Activation


Participation Criteria
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Eligibility Criteria
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Client Participants (anticipated enrollment: 288) Inclusion Criteria: Referral to study (stage 1): Age ≥ 60 years. Attends one of 18 participating Seattle, NYC, or Tampa 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. 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. Clinician Participants (anticipated enrollment: 36) Inclusion Criteria Master's degree in social work, counseling, marriage/family, or other clinical mental health degree English 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 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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Volunteer-delivered Behavioral Activation - Do More, Feel Better<br>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<br>* Behavioral Activation as delivered by trained volunteers<br>|
| Active Comparator: Master's Level Clinician-delivered Behavioral Activation<br>Traditional Behavioral Activation (BA) delivered by master's level mental health clinicians | Behavioral: Master's level clinician-delivered Behavioral Activation<br>* Behavioral Activation as delivered by trained master's level clinicians<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for Depression (HAM-D) | 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. | Change from Baseline HAM-D at 3, 6, 9, 24, and 36 weeks after treatment starts | 
| Behavioral Activation Scale (BADS) | 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. | Change from Baseline BADS at 3, 6, 9, 24, and 36 weeks after treatment starts | 

Secondary Outcome Measures

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