NCT05389189

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 Therapy (CBT), compared to treatment-as-usual (TAU) in the management of Rheumatoid Arthritis (RA) associated fatigue. This is a multicentre, two-arm parallel randomized controlled trial. Patients will be screened for eligibility, willingness to participate, and will be assessed and randomized to the experimental (MITIG.RA + TAU) or control condition (TAU) using computer-randomization. MITIG.RA will be delivered by a certified psychologist and comprises eight sessions of 2 hours, followed by two booster sessions. Outcomes will be assessed via validated self-report measures and include levels of fatigue (primary outcome), perceived impact of disease, depressive symptoms, mindfulness, self-compassion, safety, and satisfaction (secondary outcomes). Assessment will take place at baseline, post-intervention, before the first and second booster session (week 12 and 20, respectively), and at 32 and 44 weeks after the interventions' beginning.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable rheumatoid-arthritis

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
2.3 years until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

March 24, 2022

Last Update Submit

February 13, 2024

Conditions

Rheumatoid Arthritis

Keywords

Contextual-cognitive behaviouralFatigue

Outcome Measures

Primary Outcomes (1)

  • Fatigue

    Fatigue levels will be assessed by the 0-10 numerical rating scale assessing fatigue as part of the RAID.7.Higher Scores indicate higher levels of fatigue

    Week 32

Secondary Outcomes (6)

  • Satisfaction With Disease Status- PESS

    Week 32

  • Perceived Impact of the Disease

    Week 32

  • Anxiety and Depression Levels

    Week 32

  • Self-Compassion

    Week 32

  • Affective Mindfulness

    Week 32

  • +1 more secondary outcomes

Study Arms (2)

CBT Care

ACTIVE COMPARATOR

Intervention content The MITIG.RA program incorporates the following key topics during the 8 weeks of intervention (1st phase): (i) Psychoeducation on RA, sleep hygiene, exercise, and general nutritional recommendations (promote behavioural change and self-care, boost the sense of self-worth and self-efficacy) (ii) Activity engagement and pacing (iii) The functioning of the mind and its problematic patterns (iv) Focusing on the 'here and now' (mindfulness) (v) Learning new ways of self-relating - self-compassion (vi) Making room for suffering (acceptance); and (vii) Moving towards what matters (identification of valued life directions and promotion of consistent values and goals-directed behaviour). Booster sessions, at 4 and 12 weeks after completion of the first phase

Behavioral: Intervention Arm

TAU Care

NO INTERVENTION

Usual Care respecting international recommendations for the management of RA.

Interventions

Intervention ArmBEHAVIORAL

The MITIG.RA program incorporates the following key topics during the 8 weeks of intervention (1st phase): (i) Psychoeducation on RA, sleep hygiene, exercise, and general nutritional recommendations (promote behavioural change and self-care, boost the sense of self-worth and self-efficacy) (ii) Activity engagement and pacing (iii) The functioning of the mind and its problematic patterns (iv) Focusing on the 'here and now' (mindfulness) (v) Learning new ways of self-relating - self-compassion (vi) Making room for suffering (acceptance); and (vii) Moving towards what matters (identification of valued life directions and promotion of consistent values and goals-directed behaviour).

CBT Care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Duarte C, Spilker RLF, Paiva C, Ferreira RJO, da Silva JAP, Pinto AM. MITIG.RA: study protocol of a tailored psychological intervention for managing fatigue in rheumatoid arthritis randomized controlled trial. Trials. 2023 Oct 6;24(1):651. doi: 10.1186/s13063-023-07692-4.

    PMID: 37803467DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidFatigue

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jose AP daSilva, PhD

    CHUC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catia Duarte, MD

CONTACT

+351960330278catiacmduarte@gmail.com

Ricardo JO Ferreira, PhD

CONTACT

+351239400547ferreira.rjo@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 24, 2022

First Posted

May 25, 2022

Study Start

September 1, 2024

Primary Completion

February 15, 2025

Study Completion

September 30, 2025

Last Updated

February 14, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share