Internet-Based Cognitive Behavioral Therapy and Physical Activity for Insomnia

NCT07794943 | Not Yet Recruiting

• 2 other identifiers: 2024-04646-0120243219
• Study Type: interventional
• Target: 355
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Insomnia; Sleep; Physical activity; iCBT-I; Digital intervention; Cognitive behavioural therapy

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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)

  Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up

Secondary Outcomes (8)

• Sleep: Diary

  Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up

• Sleep: Device-measured

  Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up

• Physical activity: Diary

  Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up

• Physical activity: Self-report

  Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up

• Physical activity: Device-measured

  Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up

Other Outcomes (4)

• Cognitive function

  Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up

• Depression

  Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up

• Anxiety

  Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up

Study Arms (2)

iCBT-I

ACTIVE COMPARATOR

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

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

iCBT-I-PA

EXPERIMENTAL

Experimental condition: Internet-based cognitive behavioural therapy targeting insomnia combined with physical activity

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

Interventions

Internet-based cognitive behavioral therapy & physical ACtivity for INSOMNIa (iCBT-I-PA) BEHAVIORAL

Experimental condition: Internet-based cognitive behavioural therapy targeting insomnia combined with physical activity support

iCBT-I-PA

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

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

iCBT-I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Experiencing clinically relevant insomnia (Insomnia Severity Index score \>10)
• Do not meet the recommended levels of physical activity (weekly 150-300 minutes of moderate intensity physical activity or 75-150 minutes of vigorous physical activity)

You may not qualify if:

• Have any ongoing diagnosed medical conditions known to affect PA participation as assessed by intervention clinician.
• Increased risk for suicide as assessed by intervention clinician.

Sponsors & Collaborators

• Uppsala County Council, Sweden: lead
• Uppsala University: collaborator

Study Sites (1)

Primary care and health, Region Uppsala

Uppsala, Sweden

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sedentary Behavior; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Sören Spörndly-Nees, PhD

CONTACT

+46 722073089; soren.sporndly-nees@regionuppsala.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be aware of the treatment but will not be aware of the different conditions included in the RCT.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research supervisor

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: August 31, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2032
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)