Effectiveness of a Guided Self-help Intervention for Improving Sleep in University Students

Insomnia Clinical Trial

Official title:

A Study on the Effectiveness of a Guided E-health Sleep and Biological Clock Intervention in University Students (i-Sleep & BioClock)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06023693
• Other study ID #: i-Sleep&BioClockRCT
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: September 2023
• Source: Leiden University Medical Center
• Contact: Laura Pape, MSc.
• Phone: +31 71 527
• Email: l.m.pape[@]fsw.leidenuniv.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized controlled trials aims to assess the effectiveness of an online guided self-help intervention ('i-Sleep & BioClock') based on CBTi principles for university students' sleep problems. The study will involve 192 students with subthreshold insomnia who will be randomized to the intervention or online psychoeducation. The intervention consists of 5 modules completed in about 5 weeks, supported by e-coaches. Outcomes include insomnia severity, mental health symptoms, functioning, quality of life, and academic performance, measured at baseline, post-treatment (6 weeks after baseline), and 18 weeks follow-up.

Description:

Rationale: University students often suffer from sleep problems which affect their mental health and daily functioning. Cognitive behavioural therapy for insomnia (CBTi) has been proven effective in adults, but research in university students is still limited. The investigators hypothesize that a guided e-health self-help intervention based on CBTi principles ('i-Sleep & BioClock') could offer convenient treatment to students with sleep problems by reducing insomnia severity and improving mental health outcomes.

Objective: The aim of this randomized controlled trial is to assess the effectiveness of a guided e-health sleep and biological clock intervention on sleep, mental health symptoms (depression and anxiety), functioning, quality of life, and academic performance in university students.

Study design: This is a two-arm parallel group superiority randomized controlled trial, comparing a guided e-health intervention based on CBTi to online psychoeducation (PE).

Study population: The aim is to include 192 university students (Bachelor, Master and PhD) with at least subthreshold insomnia (Insomnia Severity Index ≥ 10), aged ≥ 16, who are able to speak Dutch or English, and are affiliated to one of the nine participating universities. Students with current suicidal ideation are excluded.

Intervention: The intervention will be a guided e-health intervention based on CBTi principles (i-Sleep & BioClock). It consists of 5 modules, to be completed in about 5 weeks, and is aimed at improving sleep in university students. The intervention will be entirely held online and will be supported by e-coaches.

Main study parameters/endpoints: The primary outcome will be insomnia severity. Secondary outcomes will be depression, anxiety, daily functioning, academic performance, quality of life, and sleep & light exposure diary outcomes. Outcomes will be measured at baseline, at post-treatment (6 weeks after baseline), and at 18 weeks follow-up. Mediators such as shift in chronotype and light exposure will be examined at baseline, mid-treatment, and post-treatment

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 192
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Being fluent in Dutch and/or English

• Being enrolled as a student (Bachelor, Master or PhD) in one of the Caring Universities partner universities

• Being = 16 years old

• Having self-reported sleep problems; Insomnia Severity Index = 10

Exclusion Criteria:

• Regular night shifts (Not being able to comply to the intervention due to regular night shift, meaning work between 2AM and 6AM at least once a week)

• Current risk for suicidal behaviour

Related Conditions & MeSH terms

• Insomnia

Intervention

Behavioral:
• i-Sleep & BioClock
Module 1 Psychoeducation about normal sleep and insomnia, Psychoeducation on the biological clock: the circadian rhythm, chronotypes, zeitgebers, importance of light behaviour Basic sleep hygiene: information about behaviours that are known to promote or impede sleep e.g. performing physical exercise or the use of caffeine Module 2 Sleep restriction and stimulus control: patients are taught to use the bedroom only to sleep and to restrict the time in bed to the average amount of night-time sleep Module 3 Worrying and relaxation: audio files with progressive muscle relaxation exercises are offered and techniques to stop worrying (e.g. thought blocking, evaluation and worry time) Module 4 Erroneous cognitions about sleep: the basics of cognitive behavioural therapy are explained and the most common erroneous ideas about insomnia are discussed Module 5 Summary and plan for the future
• Online Psychoeducation
Online psychoeducation about sleep and the biological clock, basic sleep hygiene

Locations

Country	Name	City	State
Netherlands	Leiden Univeristy	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence - Total number of completed modules	Measures though Log Data	Through study completion, an average of 18 weeks
Other	Adherence - Time spent in the platform (in minutes)	Measures though Log Data	Through study completion, an average of 18 weeks
Other	Adherence - Number of logins (total amount)	Measures though Log Data	Through study completion, an average of 18 weeks
Other	Adverse events	1) falling accidents, 2) traffic accidents, or 3) any other accidents related to fatigue or sleepiness, and its consequences	Mid-treatment (T1), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
Other	Stressful life events questionnaire	2 item questionnaire about whether participants experienced life-threatening or serious accident/ illness, death of someone close, physical/sexual violence or abuse or other incidents, and the consequences thereof	Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
Primary	Insomnia Severity Index	7-item self-report instrument to assess insomnia severity, scores 0-28, higher scores indicating more insomnia severity	Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
Secondary	Sleep efficiency (in minutes)	Derived from sleep and light exposure diary	Change from week 1 to week 7
Secondary	Sleep onset latency (in minutes)	Derived from sleep and light exposure diary	Change from week 1 to week 7
Secondary	Wake after sleep onset (in minutes)	Derived from sleep and light exposure diary	Change from week 1 to week 7
Secondary	Early morning awakening (in minutes)	Derived from sleep and light exposure diary	Change from week 1 to week 7
Secondary	Total sleep time (in minutes)	Derived from sleep and light exposure diary	Change from week 1 to week 7
Secondary	Time spent outside (in minutes)	Derived from sleep and light exposure diary	Change from week 1 to week 7
Secondary	Screen use before bed	Yes/ No question. Derived from sleep and light exposure diary	Change from week 1 to week 7
Secondary	Munich Chronotype Questionnaire (MCTQ)	Self-rated scale to assess individual phase of entrainment on work and work-free days, Addresses questions about: bedtime (actual time), time spent in bed awake before deciding to turn off the lights (in minutes), how long it takes to fall asleep (in minutes), wake up time (actual time), get up time (actual time) on work and work-free days. MCTQ uses the midpoint between sleep on- and offset on free days (mid-sleep on free days, MSF) to assess chronotype. The MCTQ chronotype is expressed in local time, in which earlier time refers to earlier chronotype and later time to later chronotype.	Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
Secondary	Patient Health Questionnaire (PHQ-9)	9-items self-report instrument for severity of depressive symptoms, scores ranging from 0-27, higher scores indicating more severe depression	Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
Secondary	Generalised Anxiety Disorder scale (GAD-7)	7-items self-report instrument for severity of anxiety symptoms, scores ranging from 0-21, higher scores indicating more severe anxiety	Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
Secondary	Work and Social Adjustment Scale (WSAS)	5-item self-report instrument for impairment of functioning, scores ranging from 0-40, higher scores indicating more impairment in functioning	Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
Secondary	Mental Health Quality of Life questionnaire (MHQoL)	7-item self report instrument for quality of life measure for use in people with mental health problems, scores ranging from 0-21, higher scores indicating higher quality of life, and MHQoL-VAS visual scale ranging from 0 (worst imaginable psychological wellbeing) to 10 (best imaginable psychological wellbeing)	Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)
Secondary	Dysfunctional beliefs and attitudes about sleep (DBAS-10)	10-item abbreviated measure for dysfunctional beliefs and attitudes about sleep, scored on a scale from 0 (strongly disagree) to 10 (strongly agree)	Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2)
Secondary	Pre-Sleep Arousal Scale (PSAS)	16-item self report instrument for pre-sleep arousal, 5-point Likert Scale, higher scores reflecting more arousal	Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2)
Secondary	Academic performance	Students will be asked about the grade of their last exam (Scale 1-10), the average grade of the past semester (Scale 1-10), whether they failed any exams in the past semester (Yes/No), and their study progression in the past semester in terms of ECTS achieved (30 ECTS per semester, Yes/No)	Baseline (T0), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)