Optimization of a Digital Self-guided Psychological Intervention for Insomnia: A Randomized Factorial Experiment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 447
- 试验地点
- 1
- 主要终点
- Engagement with intervention method
研究概览
简要总结
In a previous pilot study, a digital self-guided intervention for insomnia showed preliminary positive effects on insomnia symptoms. In order to optimize the digital self-guided format, this study will evaluate the added value of three treatment features on treatment engagement and insomnia symptoms. The participants will be adults with insomnia. The trial will be a 2x2x2 randomized factorial experiment, where the following features/factors will be manipulated: an optimized graphical user interface (yes or no), an adaptive treatment strategy (yes or no), and daily prompts to use the intervention (yes or no). The factorial experiment will create 8 equally large groups (1:1:1:1:1:1:1:1), who will receive the different combinations of features. The main outcome will be the effect on treatment engagement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded to what condition they are randomized to, and will not receive information concerning what features are being manipulated in the experiment.
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
- •≥ 18 years of age.
- •≥ 15 points on Insomnia Severity Index.
- •Insomnia diagnosis, according to criteria in the Diagnostic and Statistical Manual of mental disorders-5 (somatic/psychiatric comorbidity is allowed).
- •Good understanding of the Swedish language.
- •No practical obstacles to participate in treatment and assessments.
- •Daily access to computer/smart-phone/tablet with Internet access.
- •Can receive phone calls and text messages during the study period.
排除标准
- •Sleep diseases, such as narcolepsy or sleep apnea.
- •Somatic or psychiatric illnesses that either are directly contraindicated for the treatment, require other treatment, or entail symptoms/a functional level making it too difficult to participate in the study.
- •Alcohol/drug abuse, or medication with side effects on sleep (however, sleep medication is allowed).
- •Working nights or night shifts.
研究组 & 干预措施
Digital insomnia intervention
This group receives the following combination of treatment features: optimized graphical user interface (no), adaptive treatment strategy (no), daily prompts (no).
干预措施: Digital self-guided psychological intervention for insomnia (Behavioral)
Digital insomnia intervention + optimized user interface
This group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (no), daily prompts (no).
干预措施: Digital self-guided psychological intervention for insomnia (Behavioral)
Digital insomnia intervention + adaptive treatment strategy
This group receives the following combination of treatment features: optimized graphical user interface (no), adaptive treatment strategy (yes), daily prompts (no).
干预措施: Digital self-guided psychological intervention for insomnia (Behavioral)
Digital insomnia intervention + optimized user interface, adaptive treatment strategy
This group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (yes), daily prompts (no).
干预措施: Digital self-guided psychological intervention for insomnia (Behavioral)
Digital insomnia intervention + daily prompts
This group receives the following combination of treatment features: optimized graphical user interface (no), adaptive treatment strategy (no), daily prompts (yes).
干预措施: Digital self-guided psychological intervention for insomnia (Behavioral)
Digital insomnia intervention + optimized user interface, daily prompts
This group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (no), daily prompts (yes).
干预措施: Digital self-guided psychological intervention for insomnia (Behavioral)
Digital insomnia intervention + adaptive treatment strategy, daily prompts
This group receives the following combination of treatment features: optimized graphical user interface (no), adaptive treatment strategy (yes), daily prompts (yes).
干预措施: Digital self-guided psychological intervention for insomnia (Behavioral)
Digital insomnia intervention + optimized user interface, adaptive treatment strategy, daily prompts
This group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (yes), daily prompts (yes).
干预措施: Digital self-guided psychological intervention for insomnia (Behavioral)
结局指标
主要结局
Engagement with intervention method
时间窗: Immediately after treatment (4 weeks after treatment start)
Treatment engagement questionnaire (self-rated study-specific questionnaire), score range 0-21 (0-7 per item), higher is better
Engagement with intervention method
时间窗: Up to 12 months after treatment
Treatment engagement questionnaire (self-rated study-specific questionnaire), score range 0-21 (0-7 per item), higher is better
次要结局
- Change in Insomnia symptoms(Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start))
- Change in Depression symptoms(Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start))
- Change in Anxiety symptoms(Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start))
- Change in Life quality(Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start))
- Treatment credibility(2 weeks after treatment start (mid-treatment))
- Intervention/system usability(2 weeks after treatment start (mid-treatment))
- Change in Daily function(Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start))
- Treatment satisfaction(Immediately after treatment (4 weeks after treatment start))
- Change in Insomnia symptoms(Change from baseline (right before treatment start) up to 12 months after treatment)
- Change in Depression symptoms(Change from baseline (right before treatment start) up to 12 months after treatment)
- Change in Anxiety symptoms(Change from baseline (right before treatment start) up to 12 months after treatment)
- Change in Life quality(Change from baseline (right before treatment start) up to 12 months after treatment)
- Change in Daily function(Change from baseline (right before treatment start) up to 12 months after treatment)
研究者
Martin Kraepelien
Clinical Psychologist, Principal Investigator, PhD
Karolinska Institutet