Determination of Optimal Sleep Treatment Elements - Pilot (DOSE)

Determination of Optimal Sleep Treatment Elements (The DOSE Project)

Previous research has shown the efficacy of (combinations of) individual components of cognitive behavioral therapy for insomnia (CBT-I), namely sleep hygiene education, sleep optimization, 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.

In this pilot study, a smartphone and web application developed to treat insomnia using these treatment components will be tested.

Two future studies will investigate the components' relative efficacy in order to identify the most effective component or combination of components for digitized treatment of chronic insomnia by means of the Multiphase Optimization Strategy (MOST), and verify this intervention's effect in a randomized controlled trial (RCT).

Study Overview

• Status: Completed
• Conditions: Insomnia Chronic
• Intervention / Treatment: Behavioral: eCBT-I

Detailed Description

As a pilot study for a Multiphase Optimization Strategy (MOST) study, the current study will assess the effects of a newly developed smartphone and web application for digitized cognitive behavioural therapy for insomnia (eCBT-I). All treatment components, i.e., sleep hygiene education, sleep optimization, stimulus control therapy, deactivation/relaxation training, and cognitive therapy, will be tested in order to receive feedback on the functioning of the application as well as to get an initial impression of possible treatment effects.

• Study Type: Interventional
• Enrollment (Actual): 169
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Midtjylland
    • Aarhus, Midtjylland, Denmark, 8000
      • Aarhus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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, e.g., during the beta test phase

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Administration of sleep hygiene, sleep optimization, stimulus control therapy, deactivation/relaxation training, and cognitive therapy.	Behavioral: eCBT-I; Automated digital administration of sleep hygiene, sleep optimization, stimulus control therapy, deactivation/relaxation training, and cognitive therapy modules via mobile or web application, lasting approximately six weeks.
No Intervention: Control; Waitlist control (sleep diary only); access to treatment after final measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Cognitions about sleep post-intervention	Assessed with the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16).	11 weeks after study entry (randomization)
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)
Sleep diary assessed sleep efficiency (SE) at end of intervention	Based on the Consensus Sleep Diary (CSD) which measures bedtime, rise-time, sleep- and waking time, sleep onset latency, wakefulness after initial sleep onset, allowing for total sleep time, total time in bed, and sleep efficiency to be calculated. SE is calculated as the proportion of time spent asleep out of time spent in bed in percent (TST/TiB*100).	Approximately 10 weeks after study entry (randomization)
Sleep diary assessed sleep onset latency (SOL) at end of intervention	Assessed with the Consensus Sleep Diary (CSD)	Approximately 10 weeks after study entry (randomization)
Sleep diary assessed wake after sleep onset (WASO) at end of intervention	Assessed with the Consensus Sleep Diary (CSD)	Approximately 10 weeks after study entry (randomization)
Sleep diary assessed nocturnal awakenings (NA) at end of intervention	Assessed with the Consensus Sleep Diary (CSD)	Approximately 10 weeks after study entry (randomization)
Sleep diary assessed total sleep time (TST) at end of intervention	Based on the Consensus Sleep Diary (CSD) which measures bedtime, rise-time, sleep- and waking time, sleep onset latency, wakefulness after initial sleep onset, allowing for total sleep time to be calculated.	Approximately 10 weeks after study entry (randomization)
Sleep diary assessed time in bed (TiB) at end of intervention	Based on the Consensus Sleep Diary (CSD) which measures bedtime, rise-time, sleep- and waking time, sleep onset latency, wakefulness after initial sleep onset, allowing for time in bed to be calculated.	Approximately 10 weeks after study entry (randomization)
Usability post-intervention	Assessed with the mHealth App Usability Questionnaire (MAUQ).	11 weeks after study entry (randomization)

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: TrygFonden, Denmark; Enversion A/S
• Investigators: Principal Investigator: Robert Zachariae, DMSc, MSc, Aarhus University, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2022
• Primary Completion (Actual): December 3, 2022
• Study Completion (Actual): December 3, 2022

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2016-051-000001-2099-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

All individual participant data collected during the study will be made available in an irreversibly anonymized form. However, only data of those participants can be shared who have explicitly given consent to this as part of their informed consent to study participation. This means that it may not be possible to share all data underlying a certain publication.

Data will be shared exclusively for research purposes.

• IPD Sharing Time Frame: No later than six months after publication, no end date.
• IPD Sharing Access Criteria: Data will be shared exclusively with other researchers and for research purposes only. Researchers requesting the data will have to provide a methodologically sound research proposal clarifying how the data will be used and for what purpose.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No