Sleep, Pain and Quality of Life in Chronic Pain Patients

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Insomnia; Chronic Pain

Treatments: Behavioral: Education; Behavioral: Web-based Cognitive Behavioural Therapy (iCBT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04265586

HUS/577/2019

Details and patient eligibility

About

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).

Full 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.

Enrollment: 554 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• fluency in Finnish

Exclusion criteria

• severe psychiatric conditions (e.g. scizopherenia)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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554 participants in 3 patient groups

No insomnia

No Intervention group

Description:

This group contains participants who report only mild symptoms of insomnia (Insomnia Severity Index, ISI\<15).

Digital Cognitive Behavioural Therapy (iCBT)

Experimental group

Description:

This group contains participants with moderate to severe symptoms of insomnia symptoms (Insomnia Severity Index, ISI \>14). Intervention is iCBT for participants with insomnia (7-16 weeks).

Treatment:

Behavioral: Web-based Cognitive Behavioural Therapy (iCBT)

Sleep hygiene education

Experimental group

Description:

This group contains participants with moderate to severe symptoms of insomnia symptoms (Insomnia Severity Index, ISI \>14). Sleep hygiene education (approximately 1 hour)

Treatment:

Behavioral: Education