Internet-Based Cognitive Behavioral Therapy and Physical Activity for Insomnia (INSOMNIAC)

August 28, 2026 updated by: Sören Spörndly-Nees, Uppsala County Council, Sweden
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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:

  • study the feasibility regarding recruitment, randomization and adherence of study protocol.
  • analyse the within-group changes of sleep, physical activity, sedentary time, cognitive impairment, depression and anxiety, from baseline and directly after the intervention.
  • explore participants' experiences of the new treatment and of participating in the study including acceptance of study protocol.

Phase 2: An RCT with the aims to:

  • compare the effects of iCBT-i-PA and iCBT-i immediately after the intervention regarding self-reported and objective measured sleep, physical activity and sedentary time as well as self-reported cognitive impairment, depression, anxiety and pain.
  • compare the effect of iCBT-i-PA and iCBT-i 6 and 12 months after the intervention regarding self-reported and objective measured sleep, physical activity and sedentary time as well as self-reported cognitive impairment, depression, anxiety and pain.
  • evaluate the mediating role of the assessed outcomes on improved sleep.

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.

Study Type

Interventional

Enrollment (Estimated)

355

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Uppsala, Sweden
        • Primary care and health, Region Uppsala
        • Contact:
        • Principal Investigator:
          • Sören Spörndly-Nees, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 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)

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: iCBT-I
Standard care (control): Internet-based cognitive behavioural therapy targeting insomnia
Behavioral: Behavioral: Internet-based cognitive behavioral therapy & physical ACtivity for INSOMNIa (iCBT-I)
Standard care (control): Internet-based cognitive behavioural therapy targeting insomnia
Experimental: iCBT-I-PA
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)
Experimental condition: Internet-based cognitive behavioural therapy targeting insomnia combined with physical activity support

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep: Diary
Time Frame: Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up

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
Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up
Sleep: Device-measured
Time Frame: Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up

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
Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up
Physical activity: Diary
Time Frame: Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up

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)
Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up
Physical activity: Self-report
Time Frame: Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up

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
Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up
Physical activity: Device-measured
Time Frame: Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up

For Phase 1 pilot RCT and Phase 2 full-scale RCT: Device-based physical activity will be measured using the thigh-worn triaxial SENS Motion® accelerometer. The accelerometer will be worn continuously for 9 consecutive days. Physical activity metrics captured will be accelerations, steps, and daily minutes of light, moderate and vigorous physical activity.

Measurement tool: SENS Motion® accelerometer
Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up
Sedentary behaviour: Diary
Time Frame: Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up

For Phase 1 pilot RCT and Phase 2 full-scale RCT: A sedentary behaviour diary will be completed over seven consecutive days along with the physical activity diary. Sedentary behaviour metrics captured will be the duration of sitting, frequency of breaks in sitting, and the most common type of breaks across pre-defined segments of the day (i.e., morning, late morning, lunch, afternoon, dinner, evening, night).

Measurement tool: Part of the Physical Activity Diary (PAD)
Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up
Sedentary behaviour: Self-report
Time Frame: Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up

For Phase 1 pilot RCT and Phase 2 full-scale RCT: Self-reported sedentary behaviour will be measured using a single-item questionnaire capturing regarding the weekly time (in hours) spent sitting during waking hours.

Response options will be Almost all day, 13-15, 10-12, 7-9, 4-6, 1-3 hours and Never.

Measurement tool: Swedish National Board of Health and Welfare questions for sedentary behaviour (SED-GIH)
Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up
Sedentary behaviour: Device-measured
Time Frame: Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up

For Phase 1 pilot RCT and Phase 2 full-scale RCT: Device-based sedentary behaviour will be measured using the thigh-worn triaxial SENS Motion® accelerometer. The accelerometer will be worn continuously for 9 consecutive days. Sedentary behaviour metrics captured will be total minutes of waking hours spent sedentary (sitting or reclining below 1.5 METs) and daily breaks in sedentary time.

Measurement tool: SENS Motion® accelerometer
Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive function
Time Frame: Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up

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)
Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up
Depression
Time Frame: Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up

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)
Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up
Anxiety
Time Frame: Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up

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)
Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up
Pain - Numerical scale
Time Frame: Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala County Council, Sweden

Collaborators

Uppsala University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2032

Study Completion (Estimated)

December 1, 2032

Study Registration Dates

First Submitted

July 1, 2026

First Submitted That Met QC Criteria

August 28, 2026

First Posted (Actual)

August 31, 2026

Study Record Updates

Last Update Posted (Actual)

August 31, 2026

Last Update Submitted That Met QC Criteria

August 28, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-04646-01
  • 20243219 (Other Grant/Funding Number: The Kamprad Falily Foundation for Entrepreneurship, Research and Charity)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to ethical and privacy restrictions, we do not plan on making IPD publicly available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe