Status:
NOT_YET_RECRUITING
A Tailored Psychological Intervention (MITIG.RA) for Managing Fatigue in Rheumatoid Arthritis
Lead Sponsor:
Unidade Local de Saúde de Coimbra, EPE
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The objective of this study is to examine the efficacy of the Compassion and Mindfulness Intervention for RA (MITIG.RA), a novel intervention combining different components of Cognitive Behavioural Th...
Detailed Description
Primary aim: to investigate the impact of the program Compassion and Mindfulness Intervention for RA (MITIG.RA) in RA-associated fatigue in comparison to treatment as usual (TAU). Secondary aims: the...
Eligibility Criteria
Inclusion
- Fulfilling the 1987 ACR or 2010 ACR/EULAR classification criteria for RA;
- In PGA-near remission: Tender and swollen 28 joint counts and C-reactive protein (CRP) (mg/dl) \< 1, and Patient Global Assessment of disease Activity (PGA \> 1,
- RAID - fatigue ≥ 3;
- PESS \< "good"
- Under stable medication (at least 3 months).
Exclusion
- Less than 6 years of formal education;
- Unable to attend zoom meetings unaided;
- Unable to fulfil self-report questionnaires unaided;
- Pain-related comorbidities (e.g. fibromyalgia or osteoarthritis)
- Presence of other comorbid medical conditions that may cause fatigue, such as anaemia (Hb\<10mg/dL), uncontrolled hypothyroidism or cancer;
- Presence of severe psychological symptoms or disorders (e.g. psychosis, severe depression, substance abuse);
- Currently ongoing psychological interventions or formal psychiatric treatment;
- Pregnant patients;
- Otherwise disabled patients (advanced articular/bone erosion);
- Refuse to provide informed consent.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05389189
Start Date
September 1 2024
End Date
September 30 2025
Last Update
February 14 2024
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