Internet-Based Cognitive Behavioral Therapy and Physical Activity for Insomnia
Internet-Based Cognitive Behavioral Therapy and Physical Activity for Insomnia
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:
Phase 2: An RCT with the aims to:
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.
Inclusion Criteria:
Exclusion Criteria:
soren.sporndly-nees@regionuppsala.se+46 722073089