Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Insomnia: a Randomized Controlled Trial With Internal Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Pain interference
研究概览
简要总结
The goal of this clinical trial is to assess the efficacy of a digital behavioral therapy for insomnia (dBTi) in people with chronic low back pain and insomnia. The main question it aims to answer is whether a 3 week period of dBTi can improve pain-related interference 6 weeks from commencement.
Researchers will compare the treatment (dBTi) to an active control (Sleep health education modules) to see if there is a significant difference in outcomes at baseline and end-of-study (6 weeks).
详细描述
This study is an online, open-labelled, two-arm, parallel-group randomized controlled trial with embedded internal pilot study of dBTi (SleepFix) versus sleep health education control in adults with chronic low back pain (LBP) and insomnia.
To be enrolled in the study, participants are required to complete online pre-screening survey followed by a telephone screening interview with further questions and to verbally explain to participants what is required of them in this study. After interview screening, participants will receive an online baseline questionnaire to complete. Once completed, participants will be randomised to one of two study arms. The treatment arm consists of a dBTi intervention using the SleepFix mobile application. The dBTi intervention takes a minimum of 3 weeks to complete with participants allowed to use SleepFix for longer if they wish. Participants randomized to the control arm will be provide sleep health education through email released weekly during the 3-weeks of intervention treatment. Treatment control participants will receive access to SleepFix once end-of-study questionnaire has been completed.
The study will be conducted online via secure platforms with recruitment primarily through social media advertisements. The study will be coordinated from the Woolcock Institute of Medical Research, Sydney, Glebe, NSW, 2037, Australia.
Phase 1 of the study is an internal pilot study which will assess the feasibility of recruitment, data collection and reporting. The following stop-go progression criteria will be used to determine whether we proceed to phase 2 which will continue recruitment until the sample size is reached (n = 134) to determine our primary outcomes. We will:
- Go if >40% of total sample size (n = 54) are randomized to study arms within 6-months from recruitment start date.
- Stop if >40% of randomized participants fail to complete week 6 end-of-study questionnaires at 6 months from recruitment start date.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Researchers responsible for randomization and data-analysis will be blinded to the study arms.
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 aged ≥ 18 years.
- •Chronic low back pain (pain in lower back region which has been present for 3 months or more).
- •Able to give informed online consent.
- •Insomnia Severity Index Score >
- •English fluency.
- •Access to a smartphone and willingness/proficiency to use a mobile app for healthcare.
排除标准
- •Currently experiencing sciatica or other neuropathic pain condition OR inflammatory condition of the spine/vertebral column.
- •Shift-workers. Regular work that falls outside the hours between 7am and 6pm.
- •Trans-meridian travel to a destination with >2 hours' time-difference (within last 7-days and will subjective reports that they are not experiencing jet lag).
- •Serious medical and/or psychiatric illnesses/disorders (e.g. Major Depressive Disorder, epilepsy, bipolar disorder, heart failure, dementia).
- •Sleep disorders (includes: Obstructive Sleep Apnoea, Sleep Behaviour Disorder (i.e sleep talking/walking, REM), Circadian Rhythm Disorder, Restless leg syndrome, Narcolepsy or Bruxism).
- •Sleep devices (e.g. CPAP)
- •Currently receiving psychotherapy for insomnia including Cognitive Behavioural Therapy (CBT).
- •Professional driver or operate heavy machinery;
研究组 & 干预措施
Treatment
Three weeks of sleep retraining therapy - behavioral component of cognitive behavioral therapy for insomnia. This will be self-delivered by participants digitally using the smart phone App 'SleepFix'.
干预措施: sleep retraining therapy (Behavioral)
Control
Sleep health education modules delivered each week for three weeks. Modules contain information about sleep and insomnia; how insomnia affects other aspects of life; what activities influence health sleep (sleep hygiene) and information designed to dispel false beliefs about sleep
干预措施: sleep health education modules (Other)
结局指标
主要结局
Pain interference
时间窗: 6 weeks
Brief Pain Inventory (BPI) - pain interference is a subscale of the BPI consisting of 7 items which assess the extent to which pain interferes with: general activity; mood; walking; work (at home or outside); relationships; sleep; and enjoyment of life. BPI items are reported using an 11-point Likert type scale. (0 = "does not interfere"; 10 = "interferes completely"). Responses are summed to provide a global interference score between 0 and 70.
次要结局
- Patient Health Questionnaire-2 (PHQ-2)(6 weeks)
- Pain intensity(6 weeks)
- Insomnia severity index (ISI)(6 weeks)
- General Anxiety Disorder-7 (GAD-7)(6 weeks)
- EuroQol five-dimensional (EQ-5D)(6 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(6 weeks)
- Pain-related beliefs and attitudes about sleep (PBAS)(6 weeks)