Internet-Based Cognitive Behavioral Therapy and Physical Activity for Insomnia

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.

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.

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.

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.

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

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

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)

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

Cognitive function

For Phase 1 pilot RCT and Phase 2 full-scale RCT: Cognitive function will be measured using the British Columbia Cognitive Complaints Inventory (BC-CCI), a six-item scale of perceived cognitive difficulties underlying depression, including memory, attention and concentration. Example item: "Forgetfulness / Memory Problems". The items are scored from 0=Not at all to 3=Very much. The sum of the six item scores ranges from 0 to 18. Higher scores indicate more severe perceived cognitive difficulties. Measurement tool: the British Columbia Cognitive Complaints Inventory (BC-CCI)

Depression

For Phase 1 pilot RCT and Phase 2 full-scale RCT: Depression will be measured using the Montgomery-Åsberg Depression Rating Scale (MADRS-S), a nine-item self-report measure assessing the severity of depressive symptoms, with higher scores indicating greater symptom severity. Example item: "Concentration difficulties". The items are scored from 0=Item-specific lowest/No symptom anchor to 6=Item-specific most severe anchor. The sum of the nine item scores ranges from 0 to 54. Higher scores indicate greater depressive symptom severity. Measurement tool: the Montgomery-Åsberg Depression Rating Scale (MADRS-S)

Anxiety

For Phase 1 pilot RCT and Phase 2 full-scale RCT: Anxiety will be measured using the Generalized Anxiety Disorder 7-item scale assessing the severity of generalized anxiety symptoms over the past two weeks. Example item: "Feeling nervous, anxious, or on edge". The response options will be from 0=Not at all to 3=Nearly every day. The sum of the seven item scores ranges from 0 to 21. Higher scores indicate greater severity/frequency of anxiety symptoms. Measurement tool: the Generalized Anxiety Disorder scale (GAD-7)

Pain - Numerical scale

For Phase 1 pilot RCT and Phase 2 full-scale RCT: Pain will be measured using the single-item Numerical Rating Scale for Pain (NRS-P), assessing pain severity and the extent to which pain interferes with daily functioning. The item is scored from 0=No pain to 10=Worst pain imaginable. A higher score indicates greater pain and interference. Measurement tool: the Numerical Rating Scale for Pain (NRS-P)