Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D (Aim 2)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- System usability
研究概览
简要总结
The purpose of this study is to determine the extent to which an online pathway to depression treatment (iPath*D) is acceptable and usable to patients receiving cancer treatment who report symptoms of depression.
详细描述
The investigators will determine the extent to which an online pathway to depression treatment (iPath*D) is acceptable and usable to patients receiving cancer treatment who report symptoms of depression. iPath*D will be designed to increase screening, mental health literacy, and treatment access. Patients will access their iPath*D account online to review their PHQ-9 score and its interpretation, followed by an interactive depression decision aid comparing information on a range of online and in-person treatment options. Upon review of the decision aid, participants will be able to directly connect to a treatment path via embedded hyperlinks in the decision aid.
The investigators will determine the usability, acceptability, and feasibility of iPath*D. The investigators will explore the hypothesis that iPath*D will be highly usable, acceptable to patients, feasible to implement, and will result in improved mental health literacy, and greater treatment access. The tool for the study was developed during a preliminary portion (Aim 1) of the project, under D-H IRB number STUDY02001240 .
This approach uses an open-label, single arm pilot, with adult patients receiving treatment for cancer in a rural cancer clinic, St Johnsbury, VT (Dartmouth Cancer Center North) (n=30) with moderate-severe depression, Aim 2 of the project.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Adults (≥18 years)
- •New patients who are beginning treatment at Dartmouth Cancer Center North and returning for their chemo teach or radiation simulation visit
- •Can communicate in English
- •PHQ-9 ≥10 and ≤27
排除标准
- •Mild Depression (PHQ-9 ≥10)
- •Individuals who screen positive for suicidal ideation with method, intent, plan or a recent prior suicide/self-harm attempt, as determined by a positive endorsement of items 3, 4, 5 or 6 on the Columbia-Suicide Severity Rating Scale (C-SSR).
- •Individuals with bipolar disorder or psychosis (documented in the EMR)
- •Individuals currently receiving treatment for a mental health condition (documented in the EMR or self-reported during eligibility screening)
- •Significant cognitive impairment (Callahan's Six Item Screener of cognitive function ≤ 4; Self-reported during eligibility screening)
研究组 & 干预措施
iPath*D
An online platform that connects patients screening positive for clinically significant depression in cancer settings to a range of online and inperson evidence-based treatments, facilitated by an interactive DA.
干预措施: iPath*D (Other)
结局指标
主要结局
System usability
时间窗: 2 weeks
System Usability Scale (10 items; mean ≥68/100),
Acceptability of intervention
时间窗: 2 weeks
Acceptability of Intervention Measure (4 items), mean ≥4/5
Feasibility of intervention
时间窗: 2 weeks
Feasibility of Intervention Measure (4 items), mean ≥4/5
Change in Mental Health Literacy (MHL)
时间窗: Baseline, 2 weeks
A modified 10-item version for the validated multiple choice questionnaire (MCQ) for depression assesses treatment knowledge, understanding \& beliefs. Higher scores indicate higher MHL.
Change in number of patients selecting a treatment path to access
时间窗: 2 weeks, 4 weeks, 6 weeks
Click on link to access online treatment service \| indicate in self-report survey accessing local resources
次要结局
- Decisional regret (exploratory outcome)(6 weeks)
- Change in treatment initiation (exploratory outcome)(2 weeks, 4 weeks, 6 weeks)
- Change in PHQ-9 completion (exploratory outcome)(Baseline, 2 weeks, 4 weeks, 6 weeks)
- Change in treatment adherence (exploratory outcome)(2 weeks, 4 weeks, 6 weeks)
- Change in quality of life (exploratory outcome)(Baseline, 6 weeks)
- Change in PHQ-9 score (exploratory outcome)(Baseline, 2 weeks, 4 weeks, 6 weeks)
研究者
Paul J. Barr
Associate Professor
Trustees of Dartmouth College