Internet-based cognitive behavioural therapy for insomnia (iCBT-I) has shown promise for reducing insomnia symptoms. Additionally, physical activity has long been known to contribute to better sleep. The current protocol describes a planned a two-phased project aiming to examine the effect of a randomised controlled trial, including iCBT-I (standard care) alone or with additional physical activity components (iCBT-I-PA). Adults with sleep problems and insufficient physical activity levels will be included in the 6-8-week intervention. Outcomes measured will include insomnia severity (primary outcome), physical activity, sedentary behaviour, psychological distress, cognitive function and quality of life. Measures will be taken at baseline, immediately post-intervention, and at 6- and 12-month follow-ups. We hypothesise that the iCBT-I-PA group will show greater reductions in insomnia severity and increase physical activity compared to the iCBT-I group.
Design and aims: Internet-based cognitive behavioural therapy for insomnia (iCBT-I) has shown promise for treating insomnia. Physical activity has been proposed as a potential adjuvant to insomnia treatments as it has positive benefits for optimal sleep. An intervention has been developed that incorporates physical activity components into the standard iCBT-I (iCBT-I-PA). The current protocol describes the planned project which consists of two phases: Phase 1 will evaluate the feasibility and acceptability of iCBT-I-PA. The results of the feasibility and acceptability outcomes will inform adjustments to the study procedures ahead of the full-scale trial. Phase 2 will be a full-scale randomised controlled trial (RCT) with the aim to examine the effectiveness of iCBT-I-PA compared to iCBT-I as standard care (control). Phase 1: A pilot RCT with the aims to: * study the feasibility regarding recruitment, randomization and adherence of study protocol. * analyse the within-group changes of sleep, physical activity, sedentary time, cognitive impairment, depression and anxiety, from baseline and directly after the intervention. * explore participants' experiences of the new treatment and of participating in the study including acceptance of study protocol. Phase 2: An RCT with the aims to: * compare the effects of iCBT-i-PA and iCBT-i immediately after the intervention regarding self-reported and objective measured sleep, physical activity and sedentary time as well as self-reported cognitive impairment, depression, anxiety and pain. * compare the effect of iCBT-i-PA and iCBT-i 6 and 12 months after the intervention regarding self-reported and objective measured sleep, physical activity and sedentary time as well as self-reported cognitive impairment, depression, anxiety and pain. * evaluate the mediating role of the assessed outcomes on improved sleep. Methods: Adults (\>18 years) with clinically relevant insomnia (Insomnia Severity Index; ISI; score ≥11) and who are insufficiently physically active (the Swedish National Board of Health and Welfare; NBHW; questions for physical activity; \<150 min of moderate-vigorous physical activity) will be included. Eligible participants will complete baseline assessments before being randomised 1:1 to iCBT-I or iCBT-I-PA. Participants will be informed that they will receive an internet-based insomnia treatment but will be blinded to the specific intervention components and study hypotheses. The psychologists delivering the treatment and the team member managing randomisation will not be blinded after allocation. The intervention will be conducted through the Swedish e-health system 1177 Stöd och Behandling (SoB; support and treatment). The treatment consists of 6 modules completed over 6-8 weeks with weekly assigned individual tasks along with evaluations by the psychologist. The iCBT-I will include education about insomnia, CBT-I strategies for better sleep, application of CBT strategies, and conclusion/summary of the treatment. The iCBT-I-PA will include additional physical activity components based on the Swedish model of physical activity on prescription (FaR), including assessments of physical activity level and health status, physical activity self-registration (diary), goalsetting, activity plan, follow-up, strategies for overcoming barriers, and evaluation. Intervention outcomes will include the insomnia severity as the primary outcome, measured using the ISI. Sleep, physical activity and sedentary behaviour will be measured using diaries: the Physical Activity Diary (PAD) and the Swedish version of the Consensus Sleep Diary (S-CSD); the SENS Motion accelerometer, and the self-reported NBHW for physical activity and sedentary behaviour. Additionally, self-reported measures of cognitive function (Work Ability Index; WAI; and British Columbia Cognitive Complaints Inventory; BC-CCI), depression (Montgomery and Asberg Depression Rating Scale; MADRS), anxiety (Generalises Anxiety Disorder-7; GAD-7) and pain (Numeric Rating Scale for Pain; NRS) will be collected. The outcomes will be assessed at baseline, post-intervention, and at 6- and 12-month follow-ups. Analysis approach: Phase 1: Feasibility will be assessed through a number of trial process outcomes, including recruitment, retention, adherence and fidelity. Acceptability will be assessed though qualitative sub-study using semi-structured interviews with participants who were randomised to iCBT-I-PA. Preliminary, exploratory analyses will focus on within-group directional changes over time to help inform the full-scale intervention. Phase 2: For the full-scale RCT, baseline demographics will be summarised descriptively by treatment condition. The analyses will include t-tests, linear mixed-effects models (LMM) and/or repeated measures analysis of variance (ANOVA) to compare the effects of iCBT-I and iCBT-I-PA. The effects will be examined as the immediate change from pre- to post-intervention, and long-term changes from pre-intervention to 6- and 12-month follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
355
Experimental condition: Internet-based cognitive behavioural therapy targeting insomnia combined with physical activity support
Standard care (control): Internet-based cognitive behavioural therapy targeting insomnia
Primary care and health, Region Uppsala
Uppsala, Sweden
Feasibility: Pilot RCT recruitment rate
For Phase 1 pilot RCT only: Recruitment rate will be assessed as the average rate of participant recruitment as participants per week throughout the pilot RCT. Measurement tool: Study screening and enrolment log.
Time frame: Following recruitment to randomisation of the final pilot participant (up to 52 weeks).
Feasibility: Pilot RCT consent rate
For Phase 1 pilot RCT only: Consent rate will be assessed as the proportion of eligible/recruited participants who consent to participate. Measurement tool: Study screening and consent log.
Time frame: Following recruitment to randomisation of the final pilot participant (up to 52 weeks).
Feasibility: Pilot RCT adherence rate
For Phase 1 pilot RCT only: Intervention adherence will be assessed as the proportion of participants completing ≥3 modules (50% of intervention), the minimum number required for an expected change in insomnia outcomes. Measurement tool: The number of completed modules indicated by study clinician.
Time frame: Baseline and post-intervention measure (6-8 weeks)
Feasibility: Pilot RCT data collection completion rate
For Phase 1 pilot RCT only: Data collection completion will be assessed as the proportion of randomised participants who provide complete outcome data at baseline, post-intervention, 6 months, and 12 months. Measurement tool: the outcome assessment database.
Time frame: Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up
Feasibility: Pilot RCT retention rate
For Phase 1 pilot RCT only: Retention will be assessed as the proportion of randomised participants who have not withdrawn and who complete the follow-up assessments at 6 and 12 months. Measurement tool: The participant tracking and follow-up log.
Time frame: 6 and 12 months follow-up after intervention
Feasibility: Pilot RCT intervention fidelity rate
For Phase 1 pilot RCT only: Intervention fidelity will be assessed as the percentage of planned intervention components delivered as intended. Measurement tool: Study-specific intervention fidelity checklist completed by study clinicians and platform delivery records.
Time frame: Post-intervention (6-8 weeks)
Acceptability: Pilot RCT acceptability of the iCBT-I-PA intervention assessed by semi-structured interview
For Phase 1 pilot RCT only: Acceptability will be assessed using semi-structured interviews with participants randomised to the iCBT-I-PA condition who completed at least the baseline measures. Interviews will explore participants' experiences of the intervention and pilot RCT procedures, including acceptability of the intervention, randomisation, outcome assessments, follow-up schedule, and barriers and facilitators to engagement. Measurement tool: Semi-structured interview topic. Themes identified using thematic analysis.
Time frame: Post-intervention (6-8 weeks)
Insomnia severity
For Phase 1 pilot RCT and Phase 2 full-scale RCT: Insomnia severity will be the primary outcome that the intervention will aim to change. Insomnia severity will be measured using the Insomnia Severity Index (ISI). The ISI comprises seven items, measuring the severity and impact of insomnia and the extent to which it interferes with the individual's daily life. The ISI is scored on a 5-point Likert scale (0="Not at all", 4="Very much"). A sum score represents overall insomnia severity, ranging from 0 to 28. Measurement tool: The Insomnia Severity Index (ISI)
Time frame: Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up
Sleep: Diary
For Phase 1 pilot RCT and Phase 2 full-scale RCT: Sleep will be measured using a sleep diary: the Swedish version of the Core Consensus Sleep Diary (S-CSD). The S-CSD is a diary completed daily in the morning to assess nightly variation in sleep quality based on subjective sleep patterns. The S-CSD will yield Sleep Onset Latency, Wake After Sleep Onset, Total Sleep Time, Time in Bed, Sleep Efficiency, number of awakenings, and subjective sleep quality. Measurement tool: The Swedish version of the Core Consensus Sleep Diary
Time frame: Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up
Sleep: Device-measured
For Phase 1 pilot RCT and Phase 2 full-scale RCT: Sleep will be measured using a device-based measure, the thigh-worn triaxial SENS Motion® accelerometer. The accelerometer will be worn continuously for 9 consecutive days. Sleep metrics captured will be total sleep time, sleep onset/offset, sleep efficiency, and number of awakenings. Measurement tool: SENS Motion® accelerometer
Time frame: Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up
Physical activity: Diary
For Phase 1 pilot RCT and Phase 2 full-scale RCT: Physical activity will be measured using a physical activity diary. The physical activity diary will be completed over seven consecutive days. Physical activity metrics captured will be the types of physical activities, their duration (in minutes) and perceived exertion (the Borg Rating of Perceived Exertion scale; 6-20; 6=no exertion, 20=maximal exertion). Measurement tool: Physical Activity Diary (PAD)
Time frame: Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up
Physical activity: Self-report
For Phase 1 pilot RCT and Phase 2 full-scale RCT: Self-reported physical activity will be measured using a two-item questionnaire capturing the time (in minutes) spent weekly on daily-life physical activity and structured physical activity, respectively. For daily-life physical activity, response options will be 0, \<30, 30-60, 60-90, 90-120 and \>120 minutes. For structured physical activity, response options will be 0, \<30, 30-60, 60-90, 90-150, 150-300 and \>300 minutes. Measurement tool: the Swedish National Board of Health and Welfare questions for physical activity
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Time frame: Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up
Physical activity: Device-measured
For Phase 1 pilot RCT and Phase 2 full-scale RCT: Device-based physical activity will be measured using the thigh-worn triaxial SENS Motion® accelerometer. The accelerometer will be worn continuously for 9 consecutive days. Physical activity metrics captured will be accelerations, steps, and daily minutes of light, moderate and vigorous physical activity. Measurement tool: SENS Motion® accelerometer
Time frame: Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up
Sedentary behaviour: Diary
For Phase 1 pilot RCT and Phase 2 full-scale RCT: A sedentary behaviour diary will be completed over seven consecutive days along with the physical activity diary. Sedentary behaviour metrics captured will be the duration of sitting, frequency of breaks in sitting, and the most common type of breaks across pre-defined segments of the day (i.e., morning, late morning, lunch, afternoon, dinner, evening, night). Measurement tool: Part of the Physical Activity Diary (PAD)
Time frame: Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up
Sedentary behaviour: Self-report
For Phase 1 pilot RCT and Phase 2 full-scale RCT: Self-reported sedentary behaviour will be measured using a single-item questionnaire capturing regarding the weekly time (in hours) spent sitting during waking hours. Response options will be Almost all day, 13-15, 10-12, 7-9, 4-6, 1-3 hours and Never. Measurement tool: Swedish National Board of Health and Welfare questions for sedentary behaviour (SED-GIH)
Time frame: Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up
Sedentary behaviour: Device-measured
For Phase 1 pilot RCT and Phase 2 full-scale RCT: Device-based sedentary behaviour will be measured using the thigh-worn triaxial SENS Motion® accelerometer. The accelerometer will be worn continuously for 9 consecutive days. Sedentary behaviour metrics captured will be total minutes of waking hours spent sedentary (sitting or reclining below 1.5 METs) and daily breaks in sedentary time. Measurement tool: SENS Motion® accelerometer
Time frame: Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up