DOSE: Determination of Optimal Sleep Treatment Elements - MOST

• Sponsor: University of Aarhus (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05561829
• Collaborator: TrygFonden, Denmark (Industry), Enversion A/S (Other)
• Enrollment: 640
• Location: 1
• Arms: 16
• Anticipated Duration (Months): 12.7
• Patients Per Site Per Month: 50.2

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Insomnia Chronic	Behavioral: Sleep Optimization; Behavioral: Stimulus Control Therapy; Behavioral: Relaxation Training; Behavioral: Cognitive Therapy; Behavioral: Sleep Hygiene Education	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 640 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Determination of Optimal Sleep Treatment Elements (The DOSE Project)
• Actual Study Start Date: Sep 8, 2022
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sleep Hygiene Administration of sleep hygiene education (single intervention)	Behavioral: 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.
Experimental: Cognitive Therapy Administration of cognitive therapy only (single intervention)	Behavioral: 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.
Experimental: Relaxation Training Administration of relaxation training only (single intervention)	Behavioral: 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.
Experimental: Relaxation Training, Cognitive Therapy, Sleep Hygiene Administration of relaxation training, cognitive therapy, and sleep hygiene education (3 interventions)	Behavioral: 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.; Behavioral: 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.; Behavioral: 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.
Experimental: Stimulus Control Administration of stimulus control therapy only (single intervention)	Behavioral: 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.
Experimental: Stimulus Control, Cognitive Therapy, Sleep Hygiene Administration of stimulus control therapy, cognitive therapy, and sleep hygiene education (3 interventions)	Behavioral: 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.; Behavioral: 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.; Behavioral: 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.
Experimental: Stimulus Control, Relaxation Training, Sleep Hygiene Administration of stimulus control therapy, relaxation training, and sleep hygiene education (3 interventions)	Behavioral: 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.; Behavioral: 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.; Behavioral: 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.
Experimental: Stimulus Control, Relaxation Training, Cognitive Therapy Administration of stimulus control therapy, relaxation training, and cognitive therapy (3 interventions)	Behavioral: 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.; Behavioral: 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.; Behavioral: 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.
Experimental: Sleep Optimization Administration of sleep optimization only (single 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.
Experimental: Sleep Optimization, Cognitive Therapy, Sleep Hygiene Administration of sleep optimization, cognitive therapy, and sleep hygiene education (3 interventions)	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.; Behavioral: 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.; Behavioral: 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.
Experimental: Sleep Optimization, Relaxation Training, Sleep Hygiene Administration of sleep optimization, relaxation training, and sleep hygiene education (3 interventions)	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.; Behavioral: 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.; Behavioral: 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.
Experimental: Sleep Optimization, Relaxation Training, Cognitive Therapy Administration of sleep optimization, relaxation training, and cognitive therapy (3 interventions)	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.; Behavioral: 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.; Behavioral: 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.
Experimental: Sleep Optimization, Stimulus Control, Sleep Hygiene Administration of sleep optimization, stimulus control therapy, and sleep hygiene education (3 interventions)	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.; Behavioral: 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.; Behavioral: 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.
Experimental: Sleep Optimization, Stimulus Control, Cognitive Therapy Administration of sleep optimization, stimulus control therapy, and cognitive therapy (3 interventions)	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.; Behavioral: 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.; Behavioral: 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.
Experimental: Sleep Optimization, Stimulus Control, Relaxation Training Administration of sleep optimization, stimulus control therapy, and relaxation training (3 interventions)	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.; Behavioral: 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.; Behavioral: 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.
Experimental: Sleep Optimization, Stimulus Control, Relaxation Training, Cognitive Therapy, Sleep Hygiene Administration of sleep optimization, stimulus control therapy, relaxation training, cognitive therapy, and sleep hygiene education (5 interventions)	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.; Behavioral: 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.; Behavioral: 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.; Behavioral: 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.; Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. 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.

2. 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.

3. 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).

4. 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).

5. 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.

6. 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.

7. Cognitions about sleep post-intervention [11 weeks after study entry (randomization)]

   Assessed with the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16).

8. 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).

9. 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.

10. 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.

11. 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.

12. 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.

13. 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).

14. 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).

15. Application usability [11 weeks after study entry (randomization)]

    Assessed with the mHealth App Usability Questionnaire (MAUQ).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University	Aarhus	Midtjylland	Denmark	8000

Sponsors and Collaborators

• University of Aarhus
• TrygFonden, Denmark
• Enversion A/S

Investigators

• Principal Investigator: Robert Zachariae, DMSc, MSc, Aarhus University, Aarhus University Hospital

Study Documents (Full-Text)

None provided.

More Information

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• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT05561829
• Other Study ID Numbers: 2016-051-000001-2099-2
• First Posted: Sep 30, 2022
• Last Update Posted: Dec 15, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Dec 15, 2022