Improving Depression Via E-Health Access (IDEA) Study: Evaluating Uptake and Efficacy of Self-Help e-Mental Health Interventions in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Clinician/Administrator views related to interventions as assessed by qualitative interviews
研究概览
简要总结
The researchers are doing this study to learn more about which online self-help resources, including a smartphone app, an online program, or an informational website, primary care patients with depression are likely to choose and whether the chosen tool will improve their depressive symptoms and wellbeing. The researchers would also like to know how likely someone is to use the resources and their satisfaction with the resources.
详细描述
Participants will be using a self-help resource for the 6-week study period. A Care Manager will contact participants by phone, once a week, for about 5-10 minutes at a pre-arranged time. Participation will be needed for 10 weeks in total (6 weeks of active participation and a survey 1-month after the study intervention ends).
Subscription-based self-help resources being tested during the study will not be freely available after the study period. However, the researchers will share information on how to access these resources for a fee after the study period to all participants.
In addition to the time above, the researchers will collect information from participant's medical records for another 10 months after participation. The entire study is expected to last about 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who are English-speaking
- •Individuals with a Patient Health Questionnaire 9 (PHQ9) score greater than or equal to 11 or diagnosis of moderate to severe depression determined by the Care Manager during her initial psychiatric evaluation and by the study PI during panel review will supersede a low PHQ9 score.
- •Individuals with have daily internet access and a smartphone;
- •Individuals who agree to periodic contact with the care manager and study team.
排除标准
- •Individuals who have cognitive impairment that would preclude use of self-help resources
- •Individuals with already using an electronic mental health resource;
- •Individuals with unstable medical illness, e.g. active cancer;
- •Individuals with severe psychiatric symptoms (marked suicidality, psychotic symptoms, severe substance abuse)
结局指标
主要结局
Clinician/Administrator views related to interventions as assessed by qualitative interviews
时间窗: Up to approximately 18 months
Interviews are semi-structured and audio recorded
Patient preference and satisfaction with the intervention as assessed by qualitative interviews
时间窗: Up to approximately 14 months
Interviews are semi-structured and audio recorded
Change in level of functioning as assessed with the Sheehan Disability Scale (SDS)
时间窗: At baseline (before choosing an intervention) and at week 6 (when they complete the intervention)
The Sheehan Disability Scale (SDS) is a 5-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on a continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)
Patient preference, use and satisfaction of the intervention as assessed by timed structured survey
时间窗: Up to 14 months
Care manager experiences of the intervention as assessed by qualitative interviews
时间窗: Up to approximately 18 months
Interviews are semi-structured and audio recorded
Change in severity of symptoms of depression as assessed with the Patient Health Questionnaire 9 (PHQ-9) score
时间窗: At baseline (before choosing an intervention) and at week 6 (when they complete the intervention)
The PHQ-9 is an instrument for screening, diagnosing, monitoring and measuring the severity of depression: The PHQ-9 has a range of scores from 0-27. Depression Severity: 0- none, 1-4 minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Patient frequency and duration of intervention use and satisfaction as assessed by weekly structured survey
时间窗: Up to 14 months
Structured survey conducted weekly.
Patient frequency of intervention use as assessed by self-report use of tools
时间窗: Up to 14 months
As recorded in participants' printed copy of their mood-logs from the app or program.
次要结局
未报告次要终点
研究者
Jennifer Severe
Assistant Professor of Psychiatry
University of Michigan