Targeted and Tailored Messages to Enhance Depression Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 925
- 试验地点
- 6
- 主要终点
- Process of Care
研究概览
简要总结
This trial consists of two linked substudies.
Substudy 1: Activating Messages for Enhancing Primary Care Practice (AMEP2): Effectiveness Study
Substudy 2: Activating Messages for Enhancing Primary Care Practice (AMEP2): Toxicity Study
The purpose of the Effectiveness Study is to assess the comparative effectiveness of three multimedia educational interventions (a targeted educational video, a tailored interactive multimedia computer program, and an "attention control") for increasing the likelihood that primary care patients with significant depressive symptoms will seek appropriate care (n = 510). The primary study outcomes are provision of minimally acceptable initial care, reductions in depression-related stigma, and improvement in depression symptoms. (See Process of Care and Patient Outcomes in Primary Outcome Measure section.)
The purpose of the Toxicity Study is to assess the potential benefits (reduced stigma) and harms (inappropriate prescribing) associated with three multimedia depression educational interventions when administered to patients with few or no depressive symptoms (n = 308). The primary outcomes relating to this outcome are reducing depression-related stigma and reducing unnecessary prescribing. (See Toxicity in Primary Outcome Measure section.)
Both studies will look at the secondary outcome measure of patient requests for depression treatment.
详细描述
This project is an investigator-initiated study involving two sequential phases and is funded by the National Institute of Mental Health. Phase I included the use of marketing research (i.e. focus groups, adaptive conjoint analysis, and other survey methods) to produce two clinic-based interventions: a public service announcement (PSA) and interactive multimedia computer program (IMCP). The two clinic-based interventions are intended to include messages that will activate patients to talk with their physicians about specific health concerns (depression) and/or any depressive symptoms they've been experiencing. In Phase II (as described in this registration protocol), those interventions will undergo assessment in a randomized controlled effectiveness trial (RCT) in primary care settings in Sacramento and San Francisco.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 25-70
- •Visual acuity and manual dexterity to operate a laptop computer
排除标准
- •Currently being treated for depression with anti-depressant medications
研究组 & 干预措施
Attention Control Video
Two-minute video focusing on common sleep disorders.
干预措施: Sleep Hygiene Video (Behavioral)
Public Service Announcements
Demographically targeted public service announcement
干预措施: Public Service Announcement (Behavioral)
Interactive Multi-Media Computer Program
Personally tailored information about seeking care for depression based on respondent characteristics
干预措施: Interactive Multi-Media Computer Program (Behavioral)
结局指标
主要结局
Process of Care
时间窗: Within 24 hours of intervention delivery (physician post-visit assessment)
Minimally acceptable initial care, meaning 1) antidepressant prescription, 2) referral to a mental health specialist, or 3) follow up within 14 days if PHQ \>= 15 or within 30 days otherwise
Patient Outcomes
时间窗: Stigma: Within 24 hours of intervention delivery (patient post-visit assessment); depression symptoms: 12 weeks
1) Stigma as measured by a scale adapted from Kanter JW, Rusch LC, Brondino MJ. Depression self-stigma: a new measure and preliminary findings. J Nervous Mental Dis 1008; 196(9):663-70, and 2) depression symptoms measured via PHQ-8 scores.
Toxicity
时间窗: Within 24 hours of intervention delivery (patient and physician post-visit assessment, audio-recording of doctor-patient interaction at index visit)
1) Stigma as measured by a scale adapted from Kanter (see above) and 2) antidepressant prescribing by physician
次要结局
- Direct or indirect patient requests for depression treatment(Within 24 hours of intervention delivery (physician post-visit assessment, audio-recording of doctor-patient interaction at index visit))