Determination of Optimal Sleep Treatment Elements - Pilot

University of Aarhus169 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

169

Conditions

Insomnia Chronic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 11 weeks after study entry (randomization)

Secondary Outcomes

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).