Sleep, Pain and Quality of Life in Chronic Pain Patients

Helsinki University Central Hospital554 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

554

Conditions

Chronic Pain Insomnia

Interventions

EducationBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * fluency in Finnish Exclusion Criteria: * severe psychiatric conditions (e.g. scizopherenia)

Locations (2)

HUH Pain Clinic

Helsinki, Finland

Turku University Hospitla Pain Clinic

Turku, Finland

Outcomes

Primary Outcomes

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

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

Time frame: Change from Baseline HrQoL at 12 months

Secondary Outcomes

Mood -BDI-II and STAI-Y

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.

Time frame: Change from Baseline mood at 12 months

Pain related catastrophizing (PCS)

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

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

Stress and worrying tendency

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

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

Brief Pain Inventory (BPI)

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.

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

Insomnia Severity Index (ISI)

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

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

Data from ClinicalTrials.gov

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