Determination of Optimal Sleep Treatment Elements - MOST

Insomnia Chronic Clinical Trial

— DOSE  

Official title:

Determination of Optimal Sleep Treatment Elements (The DOSE Project)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05561829
• Other study ID #: 2016-051-000001-2099-2
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 8, 2022
• Est. completion date: May 2024

Study information

• Verified date: December 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 489
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Insomnia Chronic

Intervention

Behavioral:
• Sleep Optimization
Automated digital administration of a sleep optimization module via mobile or web application, lasting approximately six weeks. Based on the participant's situation and needs, sleep restriction, sleep compression, or circadian-rhythm normalization is advised and conducted. The aim is to optimise the participant's sleep efficiency.
• Stimulus Control Therapy
Automated digital administration of a stimulus control therapy module via mobile or web application, lasting approximately six weeks. The aim is to strengthen associations between sleep and the sleep environment and to eliminate conditioning of non-sleep behavior and the sleep environment.
• Relaxation Training
Automated digital administration of a relaxation training module via mobile or web application, lasting approximately six weeks. The aim is to reduce somatic tension and limit intrusive thought processes that interfere with sleep.
• Cognitive Therapy
Automated digital administration of a cognitive therapy module via mobile or web application, lasting approximately six weeks. The aim is to identify, challenge, and modify dysfunctional beliefs about sleep.
• Sleep Hygiene Education
Automated digital administration of a sleep hygiene education module via mobile or web application, lasting approximately six weeks. The aim is to identify and modify environmental and lifestyle factors that may interfere with sleep.

Locations

Country	Name	City	State
Denmark	Aarhus University	Aarhus	Midtjylland

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Enversion A/S, TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

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* Note: There are 48 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia severity post-intervention	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.	11 weeks after study entry (randomization)
Primary	Insomnia severity at 6 month follow-up	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.	6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).
Secondary	Sleep diary outcomes post-intervention	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.	11 weeks after study entry (randomization)
Secondary	Sleep diary outcomes at 6-month follow-up	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.	6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).
Secondary	Sleep quality post-intervention	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).	11 weeks after study entry (randomization)
Secondary	Sleep quality at 6-month follow-up	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).	6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).
Secondary	Daytime fatigue post-intervention	Assessed with the Functional Assessment of Chronic Illness Therapy for Fatigue (FACIT-Fatigue), which covers physical fatigue, functional fatigue, and social consequences of fatigue.	11 weeks after study entry (randomization)
Secondary	Daytime fatigue at 6-month follow-up	Assessed with the Functional Assessment of Chronic Illness Therapy for Fatigue (FACIT-Fatigue), which covers physical fatigue, functional fatigue, and social consequences of fatigue.	6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).
Secondary	Cognitions about sleep post-intervention	Assessed with the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16).	11 weeks after study entry (randomization)
Secondary	Cognitions about sleep at 6-month follow-up	Assessed with the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16).	6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).
Secondary	Physical and mental functioning post-intervention	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.	11 weeks after study entry (randomization)
Secondary	Physical and mental functioning at 6-month follow-up	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.	6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).
Secondary	Psychological distress post-intervention	Assessed with the Depression, Anxiety, and Stress Scales-21 (DASS-21), which evaluates the constructs depression, anxiety, and stress on sub-scales.	11 weeks after study entry (randomization)
Secondary	Psychological distress at 6-month follow-up	Assessed with the Depression, Anxiety, and Stress Scales-21 (DASS-21), which evaluates the constructs depression, anxiety, and stress on sub-scales.	6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).
Secondary	Health-related well-being post-intervention	Assessed with the 5-item World Health Organisation's Well-Being Index (WHO-5).	11 weeks after study entry (randomization)
Secondary	Health-related well-being at 6-month follow-up	Assessed with the 5-item World Health Organisation's Well-Being Index (WHO-5).	6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).
Secondary	Application usability	Assessed with the mHealth App Usability Questionnaire (MAUQ).	11 weeks after study entry (randomization)