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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.

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.

Status
Unknown
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240425005
Enrollment
84
Registered
2024-04-25
Start date
2024-03-18
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis Insomnia disorder Rheumatoid arthritis Insomnia disorder

Interventions

4 sessions of mindfulness based intervention group therapy conducted by trained psychologists every 2 weeks.,4 sessions of cognitive behavioral group therapy conducted by trained psychologists every 2
Experimental Behavioral,Experimental Behavioral
Mindfulness based intervention,Cognitive behavioral therapy

Sponsors

Faculty of Medicine Ramathibodi hospital Mahidol university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Disease activity 4 weeks after last session DAS28-CRP

Secondary

MeasureTime frame
Insomnia level 4 weeks after last session Modified Athens insomnia scale,Functional ability 4 weeks after last session ThaiHAQ

Countries

Thailand

Contacts

Public ContactPinyada Narawong

Faculty of medicine Ramathibodi hospital, Mahidol university

pinyada.nar@gmail.com0817261330

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026