Feasibility Trial i-Sleep & BioClock Intervention

Feasibility and Preliminary Effectiveness of a Blended E-health Intervention for Improving Sleep and the Biological Clock Among University Students (i-Sleep & BioClock)

Students often suffer from sleep problems and circadian rhythm disruptions which affect their mental health and daily functioning. The aim of this project is to develop, implement and evaluate an e-health intervention that targets the biological clock and improves the sleep patterns of university students in order to prevent the development or exacerbation of mental health problems. The investigators will assess the feasibility, usability and acceptability of the intervention in this pilot trial.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: i-Sleep & BioClock Intervention

Detailed Description

The primary objective of this study is to evaluate the e-health modules, in terms of overall acceptability, feasibility, and usability. The secondary objective is to evaluate preliminary effectiveness on the outcomes mentioned below.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • North Holland
    • Leiden, North Holland, Netherlands, 2333AK
      • Leiden Univeristy

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Being fluent in Dutch and/or English
• Being enrolled as a student (Bachelor, Master or PhD) in one of the seven participating universities (Leiden University, Vrije Universiteit Amsterdam, Utrecht University, Maastricht University, Erasmus University Rotterdam, University of Amsterdam, Inholland University of Applied Sciences)
• Being ≥ 16 years old
• Having self-reported sleep problems; Insomnia Severity Index ≥ 8 (at least subthreshold insomnia)

Exclusion Criteria:

• Current risk for suicidal behaviour

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental; Blended e-health intervention

Behavioral: i-Sleep & BioClock Intervention; The 'i-Sleep & BioClock' intervention aims at improving sleep and the biological clock among university students. It is incorporates evidence-based techniques such as cognitive behavioural therapy for insomnia (CBTi). The intervention has a duration of 5 weeks and consists of five modules: psychoeducation on insomnia, sleep hygiene and the biological clock,; stimulus control and sleep restriction therapy,; worrying and relaxation exercises,; cognitive therapy to change dysfunctional thoughts about sleep, and; summary module, relapse prevention, and plan for the future. The intervention is supported by e-coaches who give personalized written feedback. Students will fill in a sleep & light exposure diary daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity Index	7-item self-report instrument to assess insomnia severity, scores 0-28, higher scores indicating more insomnia severity	Change from baseline (T0) to 7 weeks after baseline (T1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep and light exposure diary	This diary includes measures such as sleep efficiency, sleep onset latency, total sleep time, wake after sleep onset, number of awakenings, early morning awakening, time spent outside, screen use before bedtime)	Change from week 0 (7 days prior to intervention period) to week 8 (7 days after T1)
Munich Chronotype Questionnaire (MCTQ)	Self-rated scale to assess individual phase of entrainment on work and work-free days, Addresses questions about: bedtime, time spent in bed awake before deciding to turn off the lights, how long it takes to fall asleep, wake up time, get up 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	Change from baseline (T0) to 7 weeks after baseline (T1)
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	Change from baseline (T0) to 7 weeks after baseline (T1)
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	Change from baseline (T0) to 7 weeks after baseline (T1)
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	Change from baseline (T0) to 7 weeks after baseline (T1)
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)	Change from baseline (T0) to 7 weeks after baseline (T1)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client Satisfaction Questionnaire (CSQ-8)	8-item self-report questionnaire for client satisfaction with services, total score ranging from 8-32, higher indicating higher satisfaction	7 weeks after baseline (T1)
System Usability Scale (SUS-10)	10-item self-report scale for system usability, five response options for respondents; from strongly agree to strongly disagree, scores ranging from 0-40, higher scores indicating better system usability	7 weeks after baseline (T1)
Working Alliance Inventory for guided Internet interventions (WAI-I)	12-item self-report instrument to capture alliance in guided Internet interventions, 5-point Likert scale ranging from 1 (never) to 5 (always), scores ranging from 12-60, higher scores indicating better alliance	7 weeks after baseline (T1)
Acceptability and usability of the sleep & light exposure diary	11 items on the sleep & light exposure diary, 5 point Likert Scale, scores ranging from 0-44, higher scores indicating better usability and acceptability, one visual scale on usefulness of the diary, 0 (not at all useful) to 10 (Very much useful)	7 weeks after baseline (T1)
Adherence to the program	Will be measured by the total number of completed modules and lessons, time spent in the platform, and the number of logins	Through study completion, on average 7 weeks

Collaborators and Investigators

• Sponsor: Leiden University
• Collaborators: BioClock Consortium; Caring Univeristies
• Investigators: Principal Investigator: Niki Antypa, PhD, Leiden University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: sleep; university students; e-health intervention; CBTi; biological clock
• Other Study ID Numbers: BioClockWP1.4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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