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NCT Number: NCT05561790

Determination of Optimal Sleep Treatment Elements - Pilot

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).

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Key information

Conditions

Insomnia Chronic Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University

Aarhus, Central Jutland, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eCBT-I

Behavioral

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.

Primary outcomes

  1. Insomnia severity post-intervention

    Time frame: 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.

Secondary outcomes

  1. Sleep diary assessed sleep efficiency (SE) at end of intervention

    Time frame: Approximately 10 weeks after study entry (randomization)

    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).

  2. Sleep diary assessed sleep onset latency (SOL) at end of intervention

    Time frame: Approximately 10 weeks after study entry (randomization)

    Assessed with the Consensus Sleep Diary (CSD)

  3. Sleep diary assessed wake after sleep onset (WASO) at end of intervention

    Time frame: Approximately 10 weeks after study entry (randomization)

    Assessed with the Consensus Sleep Diary (CSD)

  4. Sleep diary assessed nocturnal awakenings (NA) at end of intervention

    Time frame: Approximately 10 weeks after study entry (randomization)

    Assessed with the Consensus Sleep Diary (CSD)

  5. Sleep diary assessed total sleep time (TST) at end of intervention

    Time frame: Approximately 10 weeks after study entry (randomization)

    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.

  6. Sleep diary assessed time in bed (TiB) at end of intervention

    Time frame: Approximately 10 weeks after study entry (randomization)

    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.

  7. Daytime fatigue post-intervention

    Time frame: 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.

  8. Cognitions about sleep post-intervention

    Time frame: 11 weeks after study entry (randomization)

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

  9. Psychological distress post-intervention

    Time frame: 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.

  10. Usability post-intervention

    Time frame: 11 weeks after study entry (randomization)

    Assessed with the mHealth App Usability Questionnaire (MAUQ).

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Enversion A/S
  • TrygFonden, Denmark

Registry information

Official study title

Determination of Optimal Sleep Treatment Elements (The DOSE Project)

Acronym: DOSE

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 30, 2022
Registry last updated
Sep 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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