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NCT Number: NCT04265586

Sleep, Pain and Quality of Life in Chronic Pain Patients

The interventional study will have two main aims. First, to compare two interventions aiming to improve sleep in chronic pain patients. And secondly, to study the associations of sleep, mood, chronic pain and quality of life. Half of participants will go through iCBT intervention for insomnia and the other half will receive sleep hygiene education. Additionally, the study will gather information which patients will benefit/will not benefit the tertiary pain clinic treatment when the outcome variable is the Health-related Quality of Life (HrQoL).

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Key information

Conditions

Chronic Pain Anxiety Disorders Dyssomnias Insomnia Mental Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HUH Pain Clinic, Helsinki, Finland

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About this study

Sleep disturbances associates closely with chronic pain. It now seems that sleep problems usually precede and maintain persistent pain. Anxiety and worry frequently precede and associate with disturbed sleep and chronic pain. Depression is usually a consequence of chronic pain. Pain and depression disturb sleep further. These elements form a vicious circle where poor sleep is a critical driver.

Previous studies have shown that sleep disturbances are a major contributor to the poor health-related quality of life (HRQoL) of patients with chronic pain.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • fluency in Finnish

Exclusion criteria

  • severe psychiatric conditions (e.g. scizopherenia)

Treatment and study plan

Education

Behavioral

Sleep hygiene education is either face-to-face appointment or "video-meeting" with trained nurse.

Web-based Cognitive Behavioural Therapy (iCBT)

Behavioral

iCBT is a web-based programme (7-16 weeks) designed to treat the symptoms of insomnia.

Primary outcomes

  1. Health-related Quality of Life (HrQoL) questionnaire (15D)

    Time frame: Change from Baseline HrQoL at 12 months

    15-item questionnaire of HrQoL, ranging from 15 to 75 smaller value indicates better HrQoL

Secondary outcomes

  1. Mood -BDI-II and STAI-Y

    Time frame: Change from Baseline mood at 12 months

    Questionnaires about depression and anxiety, BDI-II values ranging from 0-63, and STAI-Y values ranging form 20-80 for both state and trait anxiety. Higher values in both questionnaires indicates higher amount of asked symptom.

  2. Pain related catastrophizing (PCS)

    Time frame: Change from Baseline pain related catatsrophizing at 12 months

    Pain catastrophizing Scale, values ranging from 0 to 52, higher values indicating higher catasrophizing tendency.

  3. Stress and worrying tendency

    Time frame: Change from Baseline stress and worrying tendency at 12 months

    Questionnaires about perceived stress and worrying tendency. Values ranges from 16 to 80, higher values indicating higher amount of worring tendency.

  4. Brief Pain Inventory (BPI)

    Time frame: Change from Baseline pain intensity and interference at 12 months

    12-item questionnaire abour self-reported pain intensity and interference. Values ranges from 0 to 120, higher values indicating higher amount of pain interference and intensity.

  5. Insomnia Severity Index (ISI)

    Time frame: Change from Baseline symptoms of insomnia at 12 months

    5-item questionnaire of self-reported symptoms of insomnia. Values ranging from 0 to 28, higher values indicating higer amount of symptoms of insomnia.

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Turku University Hospital
  • University of Helsinki

Registry information

Official study title

Sleep, Pain and Health-related Quality of Life in Chronic Pain Patients. Interventional Study

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 11, 2020
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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