Insomnia Due to Medical ConditionSoV-studienNCT03425942
Internet Administered CBT for Insomnia Comorbid With Chronic Pain
A study testing Internet Cognitive Behavioral Therapy for insomnia (ICBT-i) and Internet Applied Relaxation Techniques (IART-i) in people with Insomnia Due to Medical Condition and Chronic Pain, run by Linkoeping University at 1 site in Sweden.
Trial summary
Cognitive behavioural therapy (CBT), that is designed to be short, concise and user friendly is compared to applied relaxation techniques as treatment for insomnia comorbid with chronic pain. Both treatments are administered via internet and participants are randomized to ether treatment arm. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia Due to Medical Condition, Chronic Pain
- What is being tested?
- Internet Cognitive Behavioral Therapy for insomnia (ICBT-i) and Internet Applied Relaxation Techniques (IART-i)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSweden
- Study dates
- 9 Feb 2018to 14 May 2019
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Insomnia severity index (ISI) score > 14
- Chronic pain
Who cannot join
- Shift worker or employed as a driver, operator of dangerous equipment and such
- Sleep apnea, restless legs syndrome, narcolepsy, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
- Bipolar disorder, psychotic disorders, ongoing substance abuse
- Having received CBT for insomnia during the latest year
- Pregnancy
- Severe somatic disorder (such as ongoing cancer, severe neurological condition, insufficiently treated cardiac condition)
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- Impaired movement to such a degree that going to bed or getting out of bed requires assistance
- Not being able read or wright in Swedish
- Not having an internet-connected computer, cellular phone or tablet
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Rehabilitation medicine, IMH, Linköping University
Linköping, Östergötland County, SE 58185
About this study
Official title: Internet Administered CBT for Insomnia Comorbid With Chronic Pain Compared to Applied Relaxation Techniques - A Randomized Controlled Trial
Cognitive behavioural therapy (CBT), that is designed to be short, concise and user friendly is compared to applied relaxation techniques as treatment for insomnia comorbid with chronic pain. Both treatments are administered via internet and participants are randomized to ether treatment arm.
Read the detailed description
Internet treatment with therapist support means that measurements are collected through the Internet. Participants are recruited from a specialized pain clinic for chronic pain. All patients with sleep complaints (Insomnia Severity Index > 14) at their first visit through 2016-01-01 to 2017-07-31 are asked for participation via mail. Volunteers sign informed consent and undergo a online screening. If matching the inclusion criteria, they are contacted for a telephone interview. Subjects are assessed according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criterion for insomnia disorder, M.I.N.I. (screening for psychiatric comorbidity) and the other inclusion/exclusion criteria. The treatment, that is designed to be short, concise and user friendly as it is meant to be usable as an adjunct treatment to other main interventions for chronic pain. The treatment lasts for five weeks and focuses on the most potent CBT technics for insomnia; sleep restriction and stimulus control.
Randomization is conducted by university staff not otherwise involved in this study. Participants have equal chance to be allocated to ether CBT or applied relaxation techniques (active controls). The relaxation treatment lasts for the same amount of time (five weeks) and is designed to require similar weekly effort. Both groups fill in sleep diaries every week and weekly feedback is provided by master students supervised by clinical psychologists.
The overall hypothesis is that CBT leads to greater symptom reduction (according to the Insomnia Severity Index) compared to applied relaxation techniques.
- Conditions
- Insomnia Due to Medical Condition, Chronic Pain
- Being tested
- Internet Cognitive Behavioral Therapy for insomnia (ICBT-i), Internet Applied Relaxation Techniques (IART-i)
- Keywords
- Cognitive Behavioral Therapy, Applied Relaxation Techniques, Internet treatment
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet Cognitive Behavioral Therapy for insomnia (ICBT-i)Behavioural
This intervention lasts for five weeks. The intervention is internet-based and mainly consists of the most potent CBT technics i.e. sleep restriction and stimulus control. Weekly feedback is provided by master students supervised by clinical psychologists.
Internet Applied Relaxation Techniques (IART-i)Behavioural
This intervention lasts for five weeks. The intervention is internet-based and consists of different common applied relaxation exercises and treatments. Weekly feedback is provided by master students supervised by clinical psychologists.
| Study group | Role | What they receive |
|---|---|---|
| Internet CBT for insomnia | Experimental | The intervention consists of Internet-based Cognitive Behavioral Therapy for insomnia (ICBT-i) (the main components are sleep restriction and stimulus control) for five consecutive weeks. Receives: Behavioral: Internet Cognitive Behavioral Therapy for insomnia (ICBT-i) |
| Internet ART for insomnia | Active comparator | The intervention consists of internet-based applied relaxation exercises/techniques (ART) (different and commonly used) for five consecutive weeks.The acronyme for this intervention is (IART-i). Receives: Behavioral: Internet Applied Relaxation Techniques (IART-i) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
Measures degree of insomnia. Range 0-28 where a higher value indicates worse sleep.
Measured: Change from baseline insomnia severity (ISI) at 6 months
Secondary outcomes (6)
Sleep diary
Basis for sleep latency, total sleep time, wake time after sleep onset and sleep efficiency.
Measured: Daily during treatment (five weeks).
The Karolinska Sleepiness Scale (KSS)
Measures sleepiness on a single item numeric rating scale. Range 1-9, where a higher value indicates more sleepiness.
Measured: Change from baseline sleepiness (KSS) at 5 weeks
Patient Health Questionnaire (PHQ-9)
Measures depressive symptoms. Range 0-27, where a higher value indicates more depressive symptoms.
Measured: Change from baseline health (PHQ-9) at 6 months
Generalised Anxiety Disorder 7-item scale (GAD-7)
Measures anxiety symptoms. Range 0-21 where a higher value indicates more anxiety.
Measured: Change from baseline anxiety (GAD-7) at 6 months
Pain intensity (NRS)
Eleven stepped numeric rating scale (NRS) for average pain last seven days. Higher values indicate higher pain intensity.
Measured: Change from baseline pain intensity (NRS) at 6 months
Pain Disability Index (PDI)
Quantifying pain related disability. Range 0-70 where a higher value indicates more disability.
Measured: Change from baseline disability (PDI) at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start9 Feb 2018
- Primary completion7 May 2019
- Study completion14 May 2019
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 Insomnia Due to Medical ConditionStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bjorn Gerdle, Linkoeping University
- Investigators
- Björn Gerdle, MD, PhD, Principal investigator, Rehabilitation medicine, IMH, Linköping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425942
- Sponsor's protocol ID
- LIU-002
- Acronym
- SoV-studien
- Status last verified
- Jan 2021
- First submitted
- 24 Jan 2018
- Last updated
- 11 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wiklund T, Molander P, Lindner P, Andersson G, Gerdle B, Dragioti E. Internet-Delivered Cognitive Behavioral Therapy for Insomnia Comorbid With Chronic Pain: Randomized Controlled Trial. J Med Internet Res. 2022 Apr 29;24(4):e29258. doi: 10.2196/29258.
PubMed 35486418
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Administered CBT for Insomnia Comorbid With Chronic Pain Compared to Applied Relaxation Techniques - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03425942
- Acronym / sponsor ID
- SoV-studien / LIU-002
- Conditions
- Insomnia Due to Medical Condition, Chronic Pain
- Keywords
- Cognitive Behavioral Therapy, Applied Relaxation Techniques, Internet treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 7 May 2019 (actual)
- Study completion
- 14 May 2019 (actual)
- First posted
- 8 Feb 2018 (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.
Cognitive behavioural therapy (CBT), that is designed to be short, concise and user friendly is compared to applied relaxation techniques as treatment for insomnia comorbid with chronic pain. Both treatments are administered via internet and participants are randomized to ether treatment arm.
Detailed description
Internet treatment with therapist support means that measurements are collected through the Internet. Participants are recruited from a specialized pain clinic for chronic pain. All patients with sleep complaints (Insomnia Severity Index > 14) at their first visit through 2016-01-01 to 2017-07-31 are asked for participation via mail. Volunteers sign informed consent and undergo a online screening. If matching the inclusion criteria, they are contacted for a telephone interview. Subjects are assessed according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criterion for insomnia disorder, M.I.N.I. (screening for psychiatric comorbidity) and the other inclusion/exclusion criteria. The treatment, that is designed to be short, concise and user friendly as it is meant to be usable as an adjunct treatment to other main interventions for chronic pain. The treatment lasts for five weeks and focuses on the most potent CBT technics for insomnia; sleep restriction and stimulus control.
Randomization is conducted by university staff not otherwise involved in this study. Participants have equal chance to be allocated to ether CBT or applied relaxation techniques (active controls). The relaxation treatment lasts for the same amount of time (five weeks) and is designed to require similar weekly effort. Both groups fill in sleep diaries every week and weekly feedback is provided by master students supervised by clinical psychologists.
The overall hypothesis is that CBT leads to greater symptom reduction (according to the Insomnia Severity Index) compared to applied relaxation techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet CBT for insomnia | Experimental | Behavioral: Internet Cognitive Behavioral Therapy for insomnia (ICBT-i)The intervention consists of Internet-based Cognitive Behavioral Therapy for insomnia (ICBT-i) (the main components are sleep restriction and stimulus control) for five consecutive weeks. |
| Internet ART for insomnia | Active comparator | Behavioral: Internet Applied Relaxation Techniques (IART-i)The intervention consists of internet-based applied relaxation exercises/techniques (ART) (different and commonly used) for five consecutive weeks.The acronyme for this intervention is (IART-i). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Insomnia severity index (ISI) score > 14
- Chronic pain
Key exclusion criteria (9 listed)
- Shift worker or employed as a driver, operator of dangerous equipment and such
- Sleep apnea, restless legs syndrome, narcolepsy, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
- Bipolar disorder, psychotic disorders, ongoing substance abuse
- Having received CBT for insomnia during the latest year
- Pregnancy
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 |
|---|---|---|
| Internet Cognitive Behavioral Therapy for insomnia (ICBT-i)This intervention lasts for five weeks. The intervention is internet-based and mainly consists of the most potent CBT technics i.e. sleep restriction and stimulus control. Weekly feedback is provided by master students supervised by clinical psychologists. | Behavioural | Internet CBT for insomnia |
| Internet Applied Relaxation Techniques (IART-i)This intervention lasts for five weeks. The intervention is internet-based and consists of different common applied relaxation exercises and treatments. Weekly feedback is provided by master students supervised by clinical psychologists. | Behavioural | Internet ART for insomnia |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: Change from baseline insomnia severity (ISI) at 6 months
Measures degree of insomnia. Range 0-28 where a higher value indicates worse sleep.
6 secondary outcomes
Sleep diary
Time frame: Daily during treatment (five weeks).
The Karolinska Sleepiness Scale (KSS)
Time frame: Change from baseline sleepiness (KSS) at 5 weeks
Patient Health Questionnaire (PHQ-9)
Time frame: Change from baseline health (PHQ-9) at 6 months
Generalised Anxiety Disorder 7-item scale (GAD-7)
Time frame: Change from baseline anxiety (GAD-7) at 6 months
Pain intensity (NRS)
Time frame: Change from baseline pain intensity (NRS) at 6 months
Pain Disability Index (PDI)
Time frame: Change from baseline disability (PDI) at 6 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 11 Jan 2021.
- Derived from this study: PubMed 35486418Wiklund T, Molander P, Lindner P, Andersson G, Gerdle B, Dragioti E. Internet-Delivered Cognitive Behavioral Therapy for Insomnia Comorbid With Chronic Pain: Randomized Controlled Trial. J Med Internet Res. 2022 Apr 29;24(4):e29258. doi: 10.2196/29258.
Related trials for Insomnia Due to Medical Condition
Recruiting
Sleep Well Despite Persistent Pain Symptoms
Insomnia Chronic, Insomnia Due to Medical Condition
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.
Björn Gerdle, MD, PhD principal investigator
Rehabilitation medicine, IMH, Linköping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet Cognitive Behavioral Therapy for insomnia (ICBT-i) and Internet Applied Relaxation Techniques (IART-i) in people with Insomnia Due to Medical Condition and Chronic Pain, run by Linkoeping University at 1 site in Sweden.
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 9 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 11 Jan 2021. 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 Sweden. 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 Severity Index (ISI) (time frame: Change from baseline insomnia severity (ISI) at 6 months). 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 NCT03425942, 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 11 Jan 2021.