Determination of Optimal Sleep Treatment Elements - MOST
- Conditions
- Insomnia Chronic
- Registration Number
- NCT05561829
- Lead Sponsor
- University of Aarhus
- Brief Summary
Previous research has shown the efficacy of (combinations of) individual components of cognitive behavioral therapy for insomnia (CBT-I), namely sleep hygiene education, sleep restriction, stimulus control therapy, deactivation/relaxation training, and cognitive therapy. However, their relative effects, i.e., their effects in direct comparison with each other, are yet to be assessed. By means of the Multiphase Optimization Strategy (MOST), this study aims to investigate the components' relative efficacy in order to identify the most effective component or combination of components for digitized treatment of chronic insomnia. A future study will verify this intervention's effect in a randomized controlled trial (RCT).
- Detailed Description
The DOSE Project employs the Multiphase Optimization Strategy (MOST) to evaluate the relative efficacy of the individual cognitive behavioural therapy for insomnia (CBT-I) components. The present study represents the optimization phase of MOST, which aims to identify which combination of CBT-I components produces the best expected outcome, while taking constraints, such as economy, scalability, treatment complexity, and usability, into account.
The main objectives of the DOSE Project are
1. To conduct MOST on a multi-component smartphone or web application targeting insomnia
2. To identify the components and combination of components that demonstrate the best expected obtainable outcome
3. To examine potential moderators of the effect of the individual treatment components on insomnia severity,
4. To determine which application build (i.e., combination of components) is optimal to test in a subsequent RCT.
This study employs a fractional factorial experimental design conducted with individuals experiencing moderate-to-severe insomnia. With random allocation, participants will receive a version of the application in which one or more of the five core CBT-I components (i.e., sleep hygiene education, sleep restriction, stimulus control therapy, deactivation/relaxation training, cognitive therapy) are presented in various combinations. The intervention lasts 10 weeks, including an initial one-week assessment period.
Baseline group differences (concerning socio-demographic, disease-related, and psychosocial data) will be explored to test the success of the randomization. If differences are found, sensitivity analyses will be made to evaluate their possible influence on the results. Main effects will be analysed using Mixed Linear Models (MLMs) based on the intent-to-treat sample, comparing aggregated groups of N = 2 x 320 (e.g., plus/minus sleep restriction or plus/minus sleep hygiene etc.) on all outcome variables. MLMs account for the hierarchical, non-independent nature of the data (i.e., repeated measures nested within patients and treatment conditions), testing the time\*group interaction effect, reflecting the effect of treatment. Moderation analyses will evaluate whether individual differences in various baseline variables (e.g., physical function, expectations, computer proficiency, chronotype, etc.) influence intervention effects.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 489
- Adults (≥18 years)
- Individuals who report moderate-to-severe insomnia symptoms (a score ≥10 on the Insomnia Severity Index, ISI)
- Individuals with access to a smartphone or computer with internet connection
- Individuals who report sufficient technological proficiency (e.g., ability to download apps)
- Children (<18 years)
- Individuals who report mild or no clinically relevant insomnia symptoms (a score <10 on the ISI)
- Individuals who have a shift-work schedule or are on maternity/paternity leave, if this impacts their sleep quality or amount of sleep
- Individuals who are unable to read Danish
- Individuals who report severe physical or psychological comorbidity with known effects on sleep (e.g., psychosis, cardiovascular disease, cancer, COPD)
- Individuals who report other diagnosed sleep or circadian rhythm disorders (e.g., sleep apnea, narcolepsy)
- Individuals who have previously used the "Hvil®"-app
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Insomnia severity post-intervention 11 weeks after study entry (randomization) Assessed with the Insomnia Severity Index (ISI), with scores ranging from 0 to 28, where higher scores indicate higher insomnia severity, and a score equal to or above 10 indicates clinical significance.
Insomnia severity at 6 month follow-up 6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization). Assessed with the Insomnia Severity Index (ISI), with scores ranging from 0 to 28, where higher scores indicate higher insomnia severity, and a score equal to or above 10 indicates clinical significance.
- Secondary Outcome Measures
Name Time Method Daytime fatigue post-intervention 11 weeks after study entry (randomization) Assessed with the Functional Assessment of Chronic Illness Therapy for Fatigue (FACIT-Fatigue), which covers physical fatigue, functional fatigue, and social consequences of fatigue.
Physical and mental functioning at 6-month follow-up 6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization). Assessed with the Short Form Health Survey (SF-12), which addresses different aspects of emotional states and daily activities. The questionnaire allows for sub-scores for mental and physical health to be calculated based on population norms, with higher scores indicating better health.
Sleep diary outcomes post-intervention 11 weeks after study entry (randomization) Assessed with the Consensus Sleep Diary (CSD), which measures sleep- and waking time, sleep onset latency, wakefulness after initial sleep onset, early morning awakenings, and getting-up time, allowing for total sleep time, total time in bed, and sleep efficiency to be calculated.
Sleep quality at 6-month follow-up 6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization). Assessed with the Pittsburgh sleep quality index (PSQI), which measures clinically derived domains of sleep difficulties (i.e., subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction).
Physical and mental functioning post-intervention 11 weeks after study entry (randomization) Assessed with the Short Form Health Survey (SF-12), which addresses different aspects of emotional states and daily activities. The questionnaire allows for sub-scores for mental and physical health to be calculated based on population norms, with higher scores indicating better health.
Psychological distress post-intervention 11 weeks after study entry (randomization) Assessed with the Depression, Anxiety, and Stress Scales-21 (DASS-21), which evaluates the constructs depression, anxiety, and stress on sub-scales.
Health-related well-being post-intervention 11 weeks after study entry (randomization) Assessed with the 5-item World Health Organisation's Well-Being Index (WHO-5).
Health-related well-being at 6-month follow-up 6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization). Assessed with the 5-item World Health Organisation's Well-Being Index (WHO-5).
Sleep quality post-intervention 11 weeks after study entry (randomization) Assessed with the Pittsburgh sleep quality index (PSQI), which measures clinically derived domains of sleep difficulties (i.e., subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction).
Daytime fatigue at 6-month follow-up 6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization). Assessed with the Functional Assessment of Chronic Illness Therapy for Fatigue (FACIT-Fatigue), which covers physical fatigue, functional fatigue, and social consequences of fatigue.
Cognitions about sleep post-intervention 11 weeks after study entry (randomization) Assessed with the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16).
Cognitions about sleep at 6-month follow-up 6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization). Assessed with the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16).
Psychological distress at 6-month follow-up 6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization). Assessed with the Depression, Anxiety, and Stress Scales-21 (DASS-21), which evaluates the constructs depression, anxiety, and stress on sub-scales.
Sleep diary outcomes at 6-month follow-up 6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization). Assessed with the Consensus Sleep Diary (CSD), which measures sleep- and waking time, sleep onset latency, wakefulness after initial sleep onset, early morning awakenings, and getting-up time, allowing for total sleep time, total time in bed, and sleep efficiency to be calculated.
Application usability 11 weeks after study entry (randomization) Assessed with the mHealth App Usability Questionnaire (MAUQ).
Trial Locations
- Locations (1)
Aarhus University
🇩🇰Aarhus, Midtjylland, Denmark
Aarhus University🇩🇰Aarhus, Midtjylland, Denmark