Clinical trial NCT05389189: A Tailored Psychological Intervention (MITIG.RA) for Managing Fatigue in Rheumatoid Arthritis
Official title: A Tailored Psychological Intervention (MITIG.RA) for Managing Fatigue in Rheumatoid Arthritis: Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Contextual-cognitive behavioural
Fatigue
Lead sponsor: Centro Hospitalar e Universitário de Coimbra, E.P.E.
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fatigue
timeFrame: Week 32
Secondary outcomes:
measure: Satisfaction With Disease Status- PESS
timeFrame: Week 32
measure: Perceived Impact of the Disease
timeFrame: Week 32
measure: Anxiety and Depression Levels
timeFrame: Week 32
measure: Self-Compassion
timeFrame: Week 32
measure: Affective Mindfulness
timeFrame: Week 32
measure: Adverse Events
timeFrame: Week 32
Other outcomes:
Locations:
Study officials:
affiliation: CHUC
name: Jose AP daSilva, PhD
role: PRINCIPAL_INVESTIGATOR
References: