Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05389189 |
| Other study ID # |
OBS.SF.01/2021 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2024 |
| Est. completion date |
September 30, 2025 |
Study information
| Verified date |
February 2024 |
| Source |
Centro Hospitalar e Universitário de Coimbra, E.P.E. |
| Contact |
Catia Duarte, MD |
| Phone |
+351960330278 |
| Email |
catiacmduarte[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
