Implementation of a Self-Help Depression Program Among Orthopedic Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Proof of Concept - Acceptability measured by number of modules completed on the online program
研究概览
简要总结
The proposed study addresses the potential utility of providing an accessible self-help intervention for patients in a medical setting with an estimated diagnosis of MDD. Specifically, the study will explore whether a) such an intervention can be effectively implemented in a primary care setting and b) patients originally seeking medical attention for an orthopedic problem will be willing to seek psychological treatment and, c) improvement in depression symptoms will lead to improvement in upper and lower extremity functioning.
详细描述
The present project will be an open-label trial to assess the feasibility and acceptability of a self-help intervention among a sample of orthopedic patients. In addition to monitoring the effectiveness of the Deprexis program on depressive symptoms, the proposed project will assess whether a reduction in depressive symptoms will be associated with improvement on patient reported orthopedic impairment. The investigators will enroll 50 adults and the participants will be given the opportunity to participate in 8 weeks of the web-based online Deprexis program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients older than 18 years who present to a surgeon with an upper or lower extremity injury or disability at a participating center (see attached list)
- •A level of clinical depression more than minimal symptoms as defined by a score ≥ 10 on the Patient Health Questionnaire-9 (PHQ-9)
- •Willing and able to provide informed consent and comply with the protocol
排除标准
- •Injury or illness best treated with prompt surgery
研究组 & 干预措施
Deprexis
Participants will complete 8 weeks of online treatment via a web-based program, Deprexis.
干预措施: Deprexis (Behavioral)
结局指标
主要结局
Proof of Concept - Acceptability measured by number of modules completed on the online program
时间窗: 8 Weeks
The primary outcome will be the level of acceptability of the intervention as measured by number of completed modules on the online Deprexis program.
Proof of Concept - Acceptability measured by number of eligible participants that choose to participate
时间窗: 8 weeks
The primary outcome will be the level of acceptability of the intervention as measured by the number of eligible participants who chose to participate in the intervention.
Proof of Concept - Acceptability measured by qualitative feedback
时间窗: 8 Weeks
The primary outcome will be the level of acceptability of the intervention as measured by qualitative feedback following the intervention created by the investigators on how acceptable the study was for the participant.
Proof of Concept - Feasibility measured by qualitative feedback
时间窗: 8 Weeks
The primary outcome will be the level of acceptability of the intervention as measured by qualitative feedback following the intervention created by the investigators on how acceptable the study was for the participant.
Proof of Concept - Feasibility measured by number of eligible participants that choose to participate
时间窗: 8 Weeks
The primary outcome will be the level of feasibility of the intervention as measured by he number of eligible participants who chose to participate in the intervention.
Proof of Concept - Feasibility measured by number of modules completed on the online program
时间窗: 8 Weeks
The primary outcome will be the level of acceptability of the intervention as measured by number of completed modules on the online Deprexis program.
次要结局
- Level of Improvement of Depression (by scores on the PHQ-9)(8 weeks)
- Level of Improvement of Functioning (by scores on the PROMIS Physical Function CAT)(8 weeks)