InsomniaNCT05572697
App-delivered Cognitive-behavioral Therapy for Insomnia Among Patients With Musculoskeletal Complaints
A study testing Digital Cognitive-behavioral therapy for insomnia (dCBT-I) in people with Insomnia and Pain, Chronic, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The aim of this randomized clinical trial is to evaluate the effectiveness of app-delivered cognitive-behavioral therapy for insomnia adjunct to inpatient multimodal rehabilitation for individuals with comorbid insomnia and chronic pain, compared with rehabilitation (usual care) only. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Pain, Chronic
- What is being tested?
- Digital Cognitive-behavioral therapy for insomnia (dCBT-I)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteNorway
- Study dates
- 7 Oct 2022to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Taking part in inpatient rehabilitation due to long-term musculoskeletal complaints
- Insomnia Severity Index (ISI) score >11.
Who cannot join
- Not having a smartphone or tablet.
- Individuals with work schedules that includes night shifts during the intervention
- Pregnancy
- Inadequate opportunity to sleep or living circumstances that prevent modification of sleep patterns such as having an infant
- Currently receiving psychological treatment for insomnia
- Medical history of contraindicating use of CBT-I such as epilepsy, recent cardiac surgery, and an attack phase of multiple sclerosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: App-delivered Cognitive-behavioral Therapy for Insomnia Among Patients With Comorbid Musculoskeletal Complaints and Insomnia Referred to 4-week Inpatient Multimodal Rehabilitation
The aim of this randomized clinical trial is to evaluate the effectiveness of app-delivered cognitive-behavioral therapy for insomnia adjunct to inpatient multimodal rehabilitation for individuals with comorbid insomnia and chronic pain, compared with rehabilitation (usual care) only.
Read the detailed description
Insomnia is highly prevalent among patients receiving treatment for long-term musculoskeletal complains. Cognitive-behavioral therapy for insomnia (CBT-I) may be effective for improving sleep quality and pain-related outcomes in these patients, but the availability of this therapy is limited by few trained therapists. In this randomized clinical trial we will evaluate the effectiveness of app-delivered CBT-I adjunct to inpatients multimodal rehabilitation for individuals with comorbid insomnia and chronic pain, compared with rehabilitation (usual care) only. Patients referred to Unicare Helsefort (Norway) with long-term chronic musculoskeletal complains and insomnia are invited to the study. The rehabilitation program consists of 2+2 weeks of inpatient multimodal rehabilitation, where the patients are at home for two weeks between the rehabilitation stays. Participants in the intervention group will receive the (CBT-I) while participating in rehabilitation, while the control group will receive rehabilitation without the app (usual care).
Based on sample size calculation recruiting 15 clusters with 2:1 randomization will achieve 80 % power to detect a 4-point difference between the intervention and usual treatment group on the insomnia severity index (ISI).
Edit 25.08.23: We noted in the review process of a protocol paper that the description of our sample size calculation implied that 150 participants would be included in the study, rather than that 150 potential participants would be screened and that we anticipated that 5 from each group of the 15 clusters would be eligible (i.e. 75 included in the study). We have also revisited the sample size calculations to account for dropouts and low adherence rates known to be a problem in digital interventions. We expect a dropout rate of approximately 20 % and that around 50 % of the participants in the intervention group will complete at least four of the dCBT-I modules. Given that the per-protocol analysis is of particular interest in this study, we aim to recruit 21 clusters to account for the fact that we expect an average of four participants per cluster in the control group to complete the follow-up, and an average of two participants in the intervention group to complete at least four of the modules and attend the follow-up. As total sample size is hard to predict and the sample size is based on number of clusters we have not changed the total enrollment number.
- Conditions
- Insomnia, Pain, Chronic
- Being tested
- Digital Cognitive-behavioral therapy for insomnia (dCBT-I), Usual care
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Cognitive-behavioral therapy for insomnia (dCBT-I)Behavioural
6 week sleep intervention delivered via a smartphone app while taking part in inpatient multimodal rehabilitation for chronic pain lasting 2+2 weeks.
Usual careBehavioural
Inpatient multimodal rehabilitation for chronic pain lasting 2+2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Digital Cognitive-behavioral therapy for insomnia (dCBT-I) | Experimental | In addition to the standard rehabilitation program, participants will receive the sleep intervention delivered via a smartphone app. We will use a Norwegian a program named Assistert Selvhjelp (In English: "Assisted Self-Help"). The app is fully automated and requires no contact with healthcare personnel. It can also be assessed on computers, but in the present project we will use the app-delivered version. It is based on the principles from face-to-face CBT-I including several modules consisting of sleep hygiene, stimulus control sleep restriction, cognitive therapy, and relaxation training. The modules also consist of learning material (e.g., quizzes and materials explaining and educating the patients about important sleep dimensions). Receives: Behavioral: Digital Cognitive-behavioral therapy for insomnia (dCBT-I) |
| Usual care | Active comparator | Participants randomized to usual care will receive the standard inpatient rehabilitation program. This is a traditional rehabilitation program consisting of physical activity, mindfulness excises, psychoeducation and acceptance and commitment therapy. One of the educational sessions is about sleep. Although this educational session overlaps with some of the content included in the intervention (e.g., sleep hygiene, stimulus control), it does not include any of the interactive features of the app. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia
Degree of sleep problems measured by the insomnia severity index (ISI).
Measured: 3 months of follow-up
Secondary outcomes (9)
Insomnia
Difference in the proportion of participants that achieves an 8-point improvement in their Insomnia Severity Index -score between inpatient multidisciplinary rehabilitation + dCBT-I (intervention group) and inpatient multidisciplinary rehabilitation only (control group).
Measured: Measured at 3, 6 and 12 months of follow-up, main assessment at 3 months
Insomnia
Degree of sleep problems measured by the insomnia severity index (ISI).
Measured: 6 and 12 months of follow-up
Health-related quality of life
Measured by the EuroQol EQ5D-5L questionnaire
Measured: 3, 6 and 12 months of follow-up, main assessment at 3 months
Pain intensity
Scored from 0-100 on a visual analogue scale
Measured: 3, 6 and 12 months of follow-up, main assessment at 3 months
Sick leave
Registry data from the National Insurance Administration (NAV).
Measured: 12 months of follow-up
Use of sleep and pain medications
Data from the national prescription registry
Measured: 12 months of follow-up
Physical function
Measured by the Patient-Specific Functional Scale (PSFS). Scored 0-10.
Measured: 3, 6 and 12 months of follow-up, main assessment at 3 months
Fatigue
Scored from 0-100 on a visual analogue scale
Measured: 3, 6 and 12 months of follow-up, main assessment at 3 months
Physical activity
Physical activity measured by a questionnaire adapted from the Trøndelag Health Study (HUNT Study) which consists of three questions about frequency, duration and intensity of physical activity per week.
Measured: Measured at 3, 6 and 12 months of follow-up, main assessment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start7 Oct 2022
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized clinical trial with two parallel arms
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lene Aasdahl, Principal investigator, Norwegian University of Science and TechnologySolveig K Grudt, Study chair, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572697
- Sponsor's protocol ID
- 496297
- Status last verified
- Jul 2026
- First submitted
- 5 Oct 2022
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Skarpsno ES, Simpson MR, Seim A, Hrozanova M, Bakoy MA, Klevanger NE, Aasdahl L. App-Delivered Cognitive-Behavioral Therapy for Insomnia Among Patients with Comorbid Musculoskeletal Complaints and Insomnia Referred to 4-Week Inpatient Multimodal Rehabilitation: Protocol for a Randomized Clinical Trial. Nat Sci Sleep. 2023 Oct 11;15:799-809. doi: 10.2147/NSS.S419520. eCollection 2023.
PubMed 37850197
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- App-delivered Cognitive-behavioral Therapy for Insomnia Among Patients With Comorbid Musculoskeletal Complaints and Insomnia Referred to 4-week Inpatient Multimodal Rehabilitation
- ClinicalTrials.gov ID
- NCT05572697
- Acronym / sponsor ID
- 496297
- Conditions
- Insomnia, Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this randomized clinical trial is to evaluate the effectiveness of app-delivered cognitive-behavioral therapy for insomnia adjunct to inpatient multimodal rehabilitation for individuals with comorbid insomnia and chronic pain, compared with rehabilitation (usual care) only.
Detailed description
Insomnia is highly prevalent among patients receiving treatment for long-term musculoskeletal complains. Cognitive-behavioral therapy for insomnia (CBT-I) may be effective for improving sleep quality and pain-related outcomes in these patients, but the availability of this therapy is limited by few trained therapists. In this randomized clinical trial we will evaluate the effectiveness of app-delivered CBT-I adjunct to inpatients multimodal rehabilitation for individuals with comorbid insomnia and chronic pain, compared with rehabilitation (usual care) only. Patients referred to Unicare Helsefort (Norway) with long-term chronic musculoskeletal complains and insomnia are invited to the study. The rehabilitation program consists of 2+2 weeks of inpatient multimodal rehabilitation, where the patients are at home for two weeks between the rehabilitation stays. Participants in the intervention group will receive the (CBT-I) while participating in rehabilitation, while the control group will receive rehabilitation without the app (usual care).
Based on sample size calculation recruiting 15 clusters with 2:1 randomization will achieve 80 % power to detect a 4-point difference between the intervention and usual treatment group on the insomnia severity index (ISI).
Edit 25.08.23: We noted in the review process of a protocol paper that the description of our sample size calculation implied that 150 participants would be included in the study, rather than that 150 potential participants would be screened and that we anticipated that 5 from each group of the 15 clusters would be eligible (i.e. 75 included in the study). We have also revisited the sample size calculations to account for dropouts and low adherence rates known to be a problem in digital interventions. We expect a dropout rate of approximately 20 % and that around 50 % of the participants in the intervention group will complete at least four of the dCBT-I modules. Given that the per-protocol analysis is of particular interest in this study, we aim to recruit 21 clusters to account for the fact that we expect an average of four participants per cluster in the control group to complete the follow-up, and an average of two participants in the intervention group to complete at least four of the modules and attend the follow-up. As total sample size is hard to predict and the sample size is based on number of clusters we have not changed the total enrollment number.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized clinical trial with two parallel arms
| Arm | Type | Receives |
|---|---|---|
| Digital Cognitive-behavioral therapy for insomnia (dCBT-I) | Experimental | Behavioral: Digital Cognitive-behavioral therapy for insomnia (dCBT-I)In addition to the standard rehabilitation program, participants will receive the sleep intervention delivered via a smartphone app. We will use a Norwegian a program named Assistert Selvhjelp (In English: "Assisted Self-Help"). The app is fully automated and requires no contact with healthcare personnel. It can also be assessed on computers, but in the present project we will use the app-delivered version. It is based on the principles from face-to-face CBT-I including several modules consisting of sleep hygiene, stimulus control sleep restriction, cognitive therapy, and relaxation training. The modules also consist of learning material (e.g., quizzes and materials explaining and educating the patients about important sleep dimensions). |
| Usual care | Active comparator | Behavioral: Usual careParticipants randomized to usual care will receive the standard inpatient rehabilitation program. This is a traditional rehabilitation program consisting of physical activity, mindfulness excises, psychoeducation and acceptance and commitment therapy. One of the educational sessions is about sleep. Although this educational session overlaps with some of the content included in the intervention (e.g., sleep hygiene, stimulus control), it does not include any of the interactive features of the app. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Taking part in inpatient rehabilitation due to long-term musculoskeletal complaints
- Insomnia Severity Index (ISI) score >11.
Key exclusion criteria (6 listed)
- Not having a smartphone or tablet.
- Individuals with work schedules that includes night shifts during the intervention
- Pregnancy
- Inadequate opportunity to sleep or living circumstances that prevent modification of sleep patterns such as having an infant
- Currently receiving psychological treatment for insomnia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Cognitive-behavioral therapy for insomnia (dCBT-I)6 week sleep intervention delivered via a smartphone app while taking part in inpatient multimodal rehabilitation for chronic pain lasting 2+2 weeks. | Behavioural | Digital Cognitive-behavioral therapy for insomnia (dCBT-I) |
| Usual careInpatient multimodal rehabilitation for chronic pain lasting 2+2 weeks. | Behavioural | Usual care |
Primary outcome
Insomnia
Time frame: 3 months of follow-up
Degree of sleep problems measured by the insomnia severity index (ISI).
9 secondary outcomes
Insomnia
Time frame: Measured at 3, 6 and 12 months of follow-up, main assessment at 3 months
Insomnia
Time frame: 6 and 12 months of follow-up
Health-related quality of life
Time frame: 3, 6 and 12 months of follow-up, main assessment at 3 months
Pain intensity
Time frame: 3, 6 and 12 months of follow-up, main assessment at 3 months
Sick leave
Time frame: 12 months of follow-up
Use of sleep and pain medications
Time frame: 12 months of follow-up
Physical function
Time frame: 3, 6 and 12 months of follow-up, main assessment at 3 months
Fatigue
Time frame: 3, 6 and 12 months of follow-up, main assessment at 3 months
Physical activity
Time frame: Measured at 3, 6 and 12 months of follow-up, main assessment at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Derived from this study: PubMed 37850197Skarpsno ES, Simpson MR, Seim A, Hrozanova M, Bakoy MA, Klevanger NE, Aasdahl L. App-Delivered Cognitive-Behavioral Therapy for Insomnia Among Patients with Comorbid Musculoskeletal Complaints and Insomnia Referred to 4-Week Inpatient Multimodal Rehabilitation: Protocol for a Randomized Clinical Trial. Nat Sci Sleep. 2023 Oct 11;15:799-809. doi: 10.2147/NSS.S419520. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lene Aasdahl principal investigator
Norwegian University of Science and Technology
Solveig K Grudt study chair
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Cognitive-behavioral therapy for insomnia (dCBT-I) in people with Insomnia and Pain, Chronic, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia (time frame: 3 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05572697, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.