Internet Administered CBT for Insomnia Comorbid With Chronic Pain

NCT ID: NCT03425942

Last Updated: 2021-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-09
• Study Completion Date: 2019-05-14

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.

Conditions

Insomnia Due to Medical Condition; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Internet CBT for insomnia

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.

Group Type: EXPERIMENTAL

Internet Cognitive Behavioral Therapy for insomnia (ICBT-i)

Intervention Type: BEHAVIORAL

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 ART for insomnia

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).

Group Type: ACTIVE_COMPARATOR

Internet Applied Relaxation Techniques (IART-i)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Linkoeping University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Bjorn Gerdle

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Björn Gerdle, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rehabilitation medicine, IMH, Linköping University

Locations

Rehabilitation medicine, IMH, Linköping University

Linköping, Östergötland County, Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 35486418 (View on PubMed)

Other Identifiers

LIU-002

Identifier Type: -

Identifier Source: org_study_id