Internet Administered CBT for Insomnia Comorbid With Chronic Pain

NCT03425942 | Completed

• 1 other identifier: LIU-002
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Due to Medical Condition; Chronic Pain

Keywords

Cognitive Behavioral Therapy; Applied Relaxation Techniques; Internet treatment

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index (ISI)

  Measures degree of insomnia. Range 0-28 where a higher value indicates worse sleep.

  Change from baseline insomnia severity (ISI) at 6 months

Secondary Outcomes (6)

• Sleep diary

  Daily during treatment (five weeks).

• The Karolinska Sleepiness Scale (KSS)

  Change from baseline sleepiness (KSS) at 5 weeks

• Patient Health Questionnaire (PHQ-9)

  Change from baseline health (PHQ-9) at 6 months

• Generalised Anxiety Disorder 7-item scale (GAD-7)

  Change from baseline anxiety (GAD-7) at 6 months

• Pain intensity (NRS)

  Change from baseline pain intensity (NRS) at 6 months

Other Outcomes (3)

• Pain spreading (PS)

  Change from baseline pain spreading (PS) at 6 months

• Negative Effects Questionnaire (NEQ)

  at 5 weeks and at 6 months

• Patient Health Questionnaire (PHQ-4)

  Change from baseline health (PHQ-4) at 5 weeks

Study Arms (2)

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.

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).

Behavioral: Internet Applied Relaxation Techniques (IART-i)

Interventions

Internet Cognitive Behavioral Therapy for insomnia (ICBT-i) 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 CBT for insomnia

Internet Applied Relaxation Techniques (IART-i) 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.

Internet ART for insomnia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Rehabilitation medicine, IMH, Linköping University

Linköping, Östergötland County, SE 58185, Sweden

Location

Related Publications (1)

• 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.

  PMID: 35486418 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Björn Gerdle, MD, PhD

  Rehabilitation medicine, IMH, Linköping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants in both the experiment condition and the active control group were told that they received one of two active treatments in a comparative study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: February 8, 2018
• Study Start: February 9, 2018
• Primary Completion: May 7, 2019
• Study Completion: May 14, 2019
• Last Updated: January 11, 2021

Record last verified: 2021-01

Locations

SE (1)