A Pilot Evaluation of the Insomnia Coach Mobile App
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Objective App Usage Data
研究概览
简要总结
This pilot study is designed to test the feasibility, acceptability, and potential effectiveness of a mobile phone application (app) developed by the VA National Center for PTSD (VA NCPTSD) for use by Veterans with insomnia. The primary objective is to assess whether Veterans find the Insomnia Coach app to be satisfactory and feasible to use. Secondary objectives are to determine if use of the app improves subjective sleep quality and sleep parameters (e.g., sleep latency, wake after sleep onset, and total sleep time), as well as other important outcomes (e.g., daily functioning).
详细描述
There are high rates of insomnia among Veterans, particularly those who have been exposed to potentially traumatic situations (i.e., combat exposure) and few receive cognitive-behavioral therapy for insomnia (CBT-I), a first-line treatment for insomnia. Insomnia Coach is a mobile app for individuals with insomnia symptoms. This app provides:
- education about sleep, the development of insomnia, and evidence based behavioral and cognitive strategies
- self-assessment tools measuring insomnia severity and sleep need
- self-monitoring with a daily sleep diary
- self-management tools for relaxation and changing thinking about sleep
- individualized recommendations for a preferable sleep window (i.e., bed and rise times)
- daily reminders for behavioral changes In this pilot randomized controlled trial (RCT), 50 Veterans with significant insomnia symptoms will be recruited using flyers and social media (i.e., Facebook ads) and randomized in equal numbers to receive one of two conditions: 1) the Insomnia Coach mobile app (which is based on cognitive-behavioral therapy for insomnia (CBT-I)) and, 2) a waitlist control.
Objective use of the Insomnia Coach mobile app will be tracked to assess feasibility (i.e., will participants use the app as intended). Participants will complete measures (using Qualtrics) of sleep, insomnia severity, depression and anxiety, and functional well-being at baseline, 6 weeks (posttreatment), and 12 weeks (follow-up). At post-treatment, participants in the Insomnia Coach app condition will also be asked to report their level of satisfaction with the app and to complete a brief qualitative evaluation of their experience using the app. Waitlist control condition participants will be informed about the Insomnia Coach app and provided with information on how to download it after completion of the follow-up assessment (i.e., at 12 weeks).
The aim of this research is to learn whether individuals, particularly Veterans, with insomnia, find Insomnia Coach to be satisfactory and feasible to use. It also aims to assess if use of the app potentially improves subjective sleep quality and sleep parameters (e.g., sleep latency, wake after sleep onset, and total sleep time), as well as other important outcomes (e.g., daily functioning). If this research demonstrates that Insomnia Coach is a promising tool for individuals experiencing sleep difficulties, it has the potential to address a need using a very cost-effective, widely accessible, scalable solution that would warrant more rigorous evaluation (e.g., a full-scale RCT).
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 55
- •Owner of smartphone or tablet with Android or iOS operating system
- •Probable insomnia (i.e., ISI >=10, 3 months or more with sxs, occurring >= 3 days/week, 30 minutes or > with sleep loss)
- •Able to read/write English
- •Internet connection and active email address
排除标准
- •Comorbid sleep disorders (apnea, RLS, narcolepsy)*
- •Started or changed dosage of sleep medications or SSRIs in past 2 months
- •Unstable housing
- •Medical condition identifiably causing sleep problems
- •Significant alcohol/drug use issues
- •Current mania or psychosis
- •Currently severely depressed (PHQ-9 >20)
- •Currently receiving or having recently received insomnia therapy resembling CBT-I
- •Shift working
- •Newborn (3 mos. or younger) living in residence
- •< 5 hours of average total sleep time on 7 days of sleep diaries
结局指标
主要结局
Objective App Usage Data
时间窗: 6 weeks
Composite of app usage data comprised of button taps, sections visited, self-entered data, number of visits and days used, and time spent on the app per visit. Various combinations and aggregations of these behaviors will be explored as best indicators to optimally summarize app use.
Mobile Apps Rating Scale (MARS; Stoyanov et al., 2015)
时间窗: 6 weeks
A 20-item multidimensional, objective measure of app usability. It includes four subscales that measure an app's engagement, functionality, aesthetics, and information quality. All items are rated on a 5-point scale from "1. Inadequate" to "5. Excellent". The scores are tallied up and a mean score out of 5 is given to each of the categories scored.
System Usability Scale (SUS; Brooke, 1986)
时间窗: 6 weeks
A 10-item questionnaire of usability of products and services, including hardware, software, mobile devices, websites and applications. Items are on a 5-point scale numbered 1 to 5. Half of the items are worded negatively and half are worded positively. SUS yields a single number representing a composite measure of the overall usability of the system. To calculate the SUS score, the score contributions from each item are summed. Each item's score contribution will range from 0 to 4. For items 1,3,5,7,and 9 the score contribution is the scale position minus 1. For items 2,4,6,8 and 10, the contribution is 5 minus the scale position. Then the sum of the scores is multiplied by 2.5 to obtain the overall value of SU. SUS scores have a range of 0 to 100.
Qualitative Interview (Kuhn & Miller, 2018)
时间窗: 6 weeks
A 24-question, semi-structured interview to assess users' perceptions of Insomnia Coach.
次要结局
- Insomnia Severity Index (ISI; Bastien et al., 2011)(6 and 12 weeks)
- Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989)(6 and 12 weeks)
- PROMIS-Sleep-Related Impairment (PROMIS-SRI; Buysse et al., 2010)(6 and 12 weeks)
- Consensus Sleep Diary: Change in sleep onset latency (Carney et al., 2012)(6 and 12 weeks)
- Consensus Sleep Diary: Change in wake after sleep onset (Carney et al., 2012)(6 and 12 weeks)
- Consensus Sleep Diary: Change in sleep efficiency (Carney et al., 2012)(6 and 12 weeks)
- Generalized Anxiety Disorder - 7 Item (GAD-7; Spitzer et al., 2006)(6 and 12 weeks)
- Patient Health Questionnaire 8 (PHQ-8; Kroenke et al., 2009)(6 and 12 weeks)
研究者
Eric Kuhn
Clinical Psychologist
VA Palo Alto Health Care System