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Internet-Based Cognitive Behavioral Therapy and Physical Activity for Insomnia

NCT07794943 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 355

Last updated 2026-08-31

No results posted yet for this 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.

Conditions

  • Insomnia Disorders
  • Physical Inactivity

Interventions

BEHAVIORAL

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

Behavioral: Internet-based cognitive behavioral therapy & physical ACtivity for INSOMNIa (iCBT-I)

Standard care (control): Internet-based cognitive behavioural therapy targeting insomnia

Sponsors & Collaborators

  • Uppsala University

    collaborator OTHER

  • Uppsala County Council, Sweden

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2032-12-31
Completion
2032-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07794943 on ClinicalTrials.gov