Determination of Optimal Sleep Treatment Elements - Pilot

NCT05561790 | Completed

• 1 other identifier: 2016-051-000001-2099-1
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Insomnia Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

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

  Approximately 10 weeks after study entry (randomization)

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

  Approximately 10 weeks after study entry (randomization)

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

  Approximately 10 weeks after study entry (randomization)

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

  Approximately 10 weeks after study entry (randomization)

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

  Approximately 10 weeks after study entry (randomization)

Study Arms (2)

Intervention

EXPERIMENTAL

Administration of sleep hygiene, sleep optimization, stimulus control therapy, deactivation/relaxation training, and cognitive therapy.

Behavioral: eCBT-I

Control

NO INTERVENTION

Waitlist control (sleep diary only); access to treatment after final measurement

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• TrygFonden, Denmark: collaborator
• Enversion A/S: collaborator

Study Sites (1)

Aarhus University

Aarhus, Central Jutland, 8000, Denmark

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Robert Zachariae, DMSc, MSc

  Aarhus University, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: September 30, 2022
• Study Start: September 6, 2022
• Primary Completion: December 3, 2022
• Study Completion: December 3, 2022
• Last Updated: September 14, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: No later than six months after publication, no end date.
• 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.

Locations

DK (1)