Depression
Conditions
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.
Interventions
Behavioral Activation as delivered by trained volunteers
BEHAVIORALMaster's level clinician-delivered Behavioral Activation
Behavioral Activation as delivered by trained master's level clinicians
Sponsors
National Institute of Mental Health (NIMH)
University of South Florida
Weill Medical College of Cornell University
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Behavioral Activation Scale (BADS) | 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. |
| Hamilton Rating Scale for Depression (HAM-D) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| World Health Organization Disability Assessment Schedule (WHODAS II) | 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. |
| Client Satisfaction with Treatment (CSQ)- 3 Item | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intervention Fidelity | 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. |
Countries
United States
Contacts
Primary ContactBrittany Mosser
Backup ContactDylan Fisher
Outcome results
None listed