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A Tailored Psychological Intervention (MITIG.RA) for Managing Fatigue in Rheumatoid Arthritis (CoMIRA)

C

Centro Hospitalar e Universitário de Coimbra, E.P.E.

Status

Not yet enrolling

Conditions

Rheumatoid Arthritis

Treatments

Behavioral: Intervention Arm

Study type

Interventional

Funder types

Other

Identifiers

NCT05389189
OBS.SF.01/2021

Details and patient eligibility

About

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.

Full 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 effects the intervention has upon the patient's satisfaction with disease status, overall perceived impact of disease, depression and anxiety levels, and self-compassion skills.

Methods Selection of patients: Adult patients with RA, currently in PGA-near-remission; Rheumatoid Arthritis Impact of disease (RAID) - fatigue ≥ 3; Patient Experienced Symptom State (PESS) < "good" and under stable medication (at least 3 months).

Study design: two-arm parallel superiority randomized controlled trial. Participants will be randomized (1:1) into one of two conditions: the experimental condition (CoMIRA Program plus TAU]) and the control condition (TAU only).

Intervention: delivered in a group sessions, online, for eight consecutive weeks, followed by two booster sessions after 4 and 12 additional weeks.

Active Group: 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).

The closing session comprises a review of the main concepts and "take-home" messages, discussion of potential setbacks and strategies to deal with them, and participant's feedback on the intervention and the progress made.

The booster sessions, at 4 and 12 weeks after completion of the first phase, will focus on the revision of previously learned concepts, evaluation of potential barriers/difficulties encountered, strategies employed to deal with them, and clarification of any impending question.

Comparison: Usual Care

Procedure: The participants who accept to participate will be randomized (1:1). sessions will be delivered via zoom, in a group format. Patients will be assessed 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.

Analysis: An intention-to-treat analysis will be conducted whenever possible and complemented with per-protocol analysis if needed. Analysis of covariance (ANCOVA) will be used to assess between-group differences in fatigue scores (the primary outcome) at 3-month follow-up after the second booster session (32nd week), controlling for baseline values. The same analytic procedure will be used to examine between-group differences in perceived disease activity, depression, mindfulness, and self-compassion (secondary outcomes) at the 32nd week. All effect sizes will be reported.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

120 participants in 2 patient groups

CBT Care
Active Comparator group
Description:
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
Treatment:
Behavioral: Intervention Arm
TAU Care
No Intervention group
Description:
Usual Care respecting international recommendations for the management of RA.

Trial contacts and locations

0

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Central trial contact

Catia Duarte, MD; Ricardo JO Ferreira, PhD

Data sourced from clinicaltrials.gov

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