Specialty: Primary Care, Primary sub-specialty: Primary Care
Conditions
Interventions
Hybrid CBT comprised select components of CBT-I and interventions designed to target cognitive-behavioural processes maintaining chronic pain, based on Tang et al. (2014). Each patient was offered a t
Sponsors
University of Warwick
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or above 2. A history of chronic pain and insomnia (as indicated by medical records) 3. Pain of at least moderate severity (>4/10 on the present pain intensity numerical rating scale of the BPI) for at least 6 months 4. Clinical insomnia (>15 on the ISI, >3 nights a week, >1 moth in duration)
Exclusion criteria
Exclusion criteria: 1. Diagnosed/suspected medical/psychiatric/sleep disorders (e.g. narcolepsy) for which CBT-I is contraindicated as firstline treatment 2. Recently enrolled in or are completing a pain management programme or other psychological treatments for pain or sleep
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain intensity will be measured using the BPI - pain intensity scores at 12-weeks and 24-weeks post-randomisation. 2. Fatigue will be measured using the Multidimensional Fatigue Inventory at 12-weeks and 24-weeks post-randomisation. 3. Anxiety and depression will be measured using the Hospital Anxiety and Depression Scale at 12-weeks and 24-weeks post-randomisation. 4. Quality of life will be measured using EuroQol - EQ- 5D at 12-weeks and 24-weeks post-randomisation. | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Insomnia Severity will be using the Insomnia Severity Index (ISI) - total score at 12-weeks and 24-weeks post-randomisation. 2. Pain Interference will be measured using the Brief Pain Inventory (BPI) - Interference Score minus the sleep item at 12-weeks and 24-weeks post-randomisation. | — |
Countries
United Kingdom
Contacts
Public ContactNicole Tang
Outcome results
None listed