Evaluating the Effectiveness of a Self-management Transdiagnostic Cognitive, Behavioral, Circadian Treatment on Patient Centered Outcomes Such as Self-efficacy, Pain Control and Overall Quality of Life in the Young Adult Chronic Pain Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Study compliance to DOZE app intervention/Sleep diary
研究概览
简要总结
The overarching aim of the Young Adult Clinic (YAC) study is to evaluate the DOZE app, a digital, transdiagnostic behavioral sleep medicine and self-management approach in young adult patients (ages 18-25) with chronic pain.
详细描述
Sleep, activity, and pain interactions have the potential to impact almost all important protective and regulatory processes in the body. Long-term sleep disruption is associated with increased pain sensitivity, prolonged pain duration, and development of chronic pain. Degree of pain relief can directly impact the quality and disruption of sleep, mood, behavior, social participation, and has a devastating impact on Health Related Quality of Life (HRQL).
Transdiagnostic behavioral sleep medicine and self-management is a behavioral modification approach and is currently a frontline therapy like Cognitive behavioral therapy for insomnia (CBTi) in adults with sleep disorders. However, it is still in early stages of development for adolescent and young adult populations, and less so for youth with co-morbid mental and physical health conditions and chronic pain.
Primary aim: Assess the feasibility of implementing the DOZE app.
Secondary aim:
- To examine the variance in effectiveness outcomes, including sleep health, pain, and overall Health Related Quality of Life (HRQL).
- To determine the required sample size for a future definitive trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Young adult patients aged 18 - 25 years old, who have
- •Non-malignant chronic pain lasting more than 3 months, with
- •Clinically assessed as having a sleep disorder
- •English speaking with
- •Access to a mobile phone or a computer with internet access.
排除标准
- •Patients who require urgent CBT treatment as per their health care provider
- •Patients who have received CBT in the past 3 months
- •Patients participating in other psychological treatments and/or drug trials during the study
- •Patients who have other significant medical conditions- Life threatening (e.g. cancer), neurological conditions (e.g. epilepsy)
- •Patients who have other significant psychiatric conditions-Severe depression or active suicide intent
- •Situations resulting in forced sleep disruption or derangement of sleep schedule such as night shift work > 2 nights per week in the past 3months
- •Pregnancy or breastfeeding.
- •Inability to communicate with health care providers or the research personnel
- •Inability to fill out self-report questionnaires, study materials, or follow instructions.
研究组 & 干预措施
Intervention arm
A cohort of YAC patients to be studied, pre & post-intervention, prospectively. All participants will be assigned to the intervention (complete DOZE app: Sleep diary and DOZE modules).
干预措施: DOZE app (Behavioral)
结局指标
主要结局
Study compliance to DOZE app intervention/Sleep diary
时间窗: 10 weeks
Number of Participants completing/using the DOZE app and completing the sleep diary daily during 10 weeks study intervention
Study recruitment/retention
时间窗: 12 weeks
Number of Participants recruited/dropping out of study (accrual/dropout rates)
Study DOZE app treatment evaluation
时间窗: 12 weeks
Participants' scoring on a 5 point Likert scale pre and post study intervention
Issues and concerns reported via phone calls and emails (Fidelity)
时间窗: 12 weeks
Issues and concerns reported while using the intervention tracked by a research assistant, control strategy or outcome measures will be monitored. Can the intervention, and outcome measures be completed as planned or patient not comply with use.
次要结局
- Patient reported improvement in sleep(12 weeks)
- Patient reported improvement in Health Related Quality Of Life(12 weeks)
- Patient reported Global Impression of Change(12 weeks)
- Patient reported improvement in pain(12 weeks)