sing talking therapies in general practice to treat pain-related insomnia

Not Applicable

Completed

• Conditions: Specialty: Primary Care, Primary sub-specialty: Primary Care; Health Category: Neurological; Disease/Condition: Episodic and paroxysmal disorders; Nervous System Diseases; Insomnia

• Registration Number: ISRCTN17294365
• Lead Sponsor: niversity of Warwick

Brief Summary

2020 results in https://pubmed.ncbi.nlm.nih.gov/32193269/ (added 26/10/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-10-31
• Study Start: 2019-01-08
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Insomnia Severity will be using the Insomnia Severity Index (ISI) - total score at 12-weeks and 24-weeks post-randomisation.<br> 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.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Pain intensity will be measured using the BPI - pain intensity scores at 12-weeks and 24-weeks post-randomisation.<br> 2. Fatigue will be measured using the Multidimensional Fatigue Inventory at 12-weeks and 24-weeks post-randomisation.<br> 3. Anxiety and depression will be measured using the Hospital Anxiety and Depression Scale at 12-weeks and 24-weeks post-randomisation.<br> 4. Quality of life will be measured using EuroQol - EQ- 5D at 12-weeks and 24-weeks post-randomisation.<br>