Chronic Pain, Insomnia
Conditions
Keywords
Health-related Quality of Life, Anxiety, Pain intensity, Pain interference, Symptoms of insomnia
Brief summary
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).
Detailed description
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.
Interventions
BEHAVIORALEducation
Sleep hygiene education is either face-to-face appointment or video-meeting with trained nurse.
BEHAVIORALWeb-based Cognitive Behavioural Therapy (iCBT)
iCBT is a web-based programme (7-16 weeks) designed to treat the symptoms of insomnia.
Sponsors
University of Helsinki
Turku University Hospital
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* fluency in Finnish
Exclusion criteria
* severe psychiatric conditions (e.g. scizopherenia)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-related Quality of Life (HrQoL) questionnaire (15D) | Change from Baseline HrQoL at 12 months | 15-item questionnaire of HrQoL, ranging from 15 to 75 smaller value indicates better HrQoL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mood -BDI-II and STAI-Y | 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. |
| Pain related catastrophizing (PCS) | Change from Baseline pain related catatsrophizing at 12 months | Pain catastrophizing Scale, values ranging from 0 to 52, higher values indicating higher catasrophizing tendency. |
| Stress and worrying tendency | 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. |
| Brief Pain Inventory (BPI) | 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. |
| Insomnia Severity Index (ISI) | 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. |
Countries
Finland
Outcome results
None listed