The effect of mindfulness based intervention and cognitive-behavioral therapy on disease activity and sleep quality in patients with rheumatoid arthritis and concomitant insomnia: a randomized controlled trial.

Phase 1

Recruiting

• Conditions: Rheumatoid arthritisInsomnia disorder; Rheumatoid arthritis; Insomnia disorder

• Registration Number: TCTR20240425005
• Lead Sponsor: Faculty of Medicine Ramathibodi hospital Mahidol university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-25
• Study Completion: 2024-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. Rheumatoid arthritis patients with moderate disease activity
2. Age 18 years and older
3. Concomitant insomnia disorder
4. No DMARDs and/or biologics adjustment for 8 weeks prior to study

Exclusion Criteria

1. History of major depression disorder and/or anxiety disorder
2. Concomitant fibromyalgia
3. Patients deny to participate in study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease activity 4 weeks after last session DAS28-CRP

Secondary Outcome Measures

Name	Time	Method
Insomnia level 4 weeks after last session Modified Athens insomnia scale,Functional ability 4 weeks after last session ThaiHAQ