Internet-Based Cognitive Behavioral Therapy and Physical Activity for Insomnia

Condition(s) studied

Investigational drug(s) / intervention(s)

Internet-based cognitive behavioral therapy & physical ACtivity for INSOMNIa (iCBT-I-PA): Experimental condition: Internet-based cognitive behavioural therapy targeting insomnia combined with physical activity support

Behavioral: Internet-based cognitive behavioral therapy & physical ACtivity for INSOMNIa (iCBT-I): Standard care (control): Internet-based cognitive behavioural therapy targeting insomnia

Study summary

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.

Eligibility

Primary outcome measure(s)

• Feasibility: Pilot RCT recruitment rate — Following recruitment to randomisation of the final pilot participant (up to 52 weeks).
  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 — Following recruitment to randomisation of the final pilot participant (up to 52 weeks).
  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 — Baseline and post-intervention measure (6-8 weeks)
  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 — Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up
  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.
• Feasibility: Pilot RCT retention rate — 6 and 12 months follow-up after intervention
  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.
• Feasibility: Pilot RCT intervention fidelity rate — Post-intervention (6-8 weeks)
  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.
• Acceptability: Pilot RCT acceptability of the iCBT-I-PA intervention assessed by semi-structured interview — Post-intervention (6-8 weeks)
  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.
• Insomnia severity — Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up
  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)

Trial sites (1)

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