Clinical trial NCT03425942: Internet Administered CBT for Insomnia Comorbid With Chronic Pain
Official title: Internet Administered CBT for Insomnia Comorbid With Chronic Pain Compared to Applied Relaxation Techniques - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Due to Medical Condition
Chronic Pain
Keywords: Cognitive Behavioral Therapy
Applied Relaxation Techniques
Internet treatment
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2018-02-08
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Insomnia severity index (ISI) score \> 14
* Chronic pain

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Change from baseline insomnia severity (ISI) at 6 months
Secondary outcomes:
measure: Sleep diary
timeFrame: Daily during treatment (five weeks).
measure: The Karolinska Sleepiness Scale (KSS)
timeFrame: Change from baseline sleepiness (KSS) at 5 weeks
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Change from baseline health (PHQ-9) at 6 months
measure: Generalised Anxiety Disorder 7-item scale (GAD-7)
timeFrame: Change from baseline anxiety (GAD-7) at 6 months
measure: Pain intensity (NRS)
timeFrame: Change from baseline pain intensity (NRS) at 6 months
measure: Pain Disability Index (PDI)
timeFrame: Change from baseline disability (PDI) at 6 months
Other outcomes:
measure: Pain spreading (PS)
timeFrame: Change from baseline pain spreading (PS) at 6 months
measure: Negative Effects Questionnaire (NEQ)
timeFrame: at 5 weeks and at 6 months
measure: Patient Health Questionnaire (PHQ-4)
timeFrame: Change from baseline health (PHQ-4) at 5 weeks
Locations:
city: Linköping
country: Sweden
facility: Rehabilitation medicine, IMH, Linköping University
state: Östergötland
Study officials:
affiliation: Rehabilitation medicine, IMH, Linköping University
name: Björn Gerdle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.