Lay-Delivered Behavioral Activation in Senior Centers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 288
- 试验地点
- 25
- 主要终点
- Hamilton Rating Scale for Depression (HAM-D)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Client Participants (anticipated enrollment: 288)
- •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
排除标准
- •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
研究组 & 干预措施
Volunteer-delivered Behavioral Activation - "Do More, Feel Better"
"Do More, Feel Better" (DMFB) is a streamlined, simplified version of Behavioral Activation (BA) delivered by lay volunteers to depressed senior center clients.
干预措施: Volunteer-delivered Behavioral Activation (Behavioral)
Master's Level Clinician-delivered Behavioral Activation
Traditional Behavioral Activation (BA) delivered by master's level mental health clinicians
干预措施: Master's level clinician-delivered Behavioral Activation (Behavioral)
结局指标
主要结局
Hamilton Rating Scale for Depression (HAM-D)
时间窗: 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.
Behavioral Activation Scale (BADS)
时间窗: 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.
次要结局
- Client Satisfaction with Treatment (CSQ)- 3 Item(Administered at 3, 6, and 9 weeks after treatment starts)
- World Health Organization Disability Assessment Schedule (WHODAS II)(Change from Baseline WHODAS-II at 3, 6, 9, 24, and 36 weeks after treatment starts)
研究者
Patrick Raue
Professor, School of Medicine: Psychiatry: Population Health
University of Washington