Rheumatoid ArthritisCoMIRANCT05389189
A Tailored Psychological Intervention (MITIG.RA) for Managing Fatigue in Rheumatoid Arthritis
A study testing Intervention Arm in people with Rheumatoid Arthritis, run by Unidade Local de Saúde de Coimbra, EPE.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Intervention Arm
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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);
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- Currently ongoing psychological interventions or formal psychiatric treatment;
- Pregnant patients;
- Otherwise disabled patients (advanced articular/bone erosion);
- Refuse to provide informed consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Tailored Psychological Intervention (MITIG.RA) for Managing Fatigue in Rheumatoid Arthritis: Protocol for a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Intervention Arm
- Keywords
- Contextual-cognitive behavioural, Fatigue
- Medical subject headings
- Arthritis, Rheumatoid, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention ArmBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Intervention Arm |
| TAU Care | No intervention | Usual Care respecting international recommendations for the management of RA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 32
Secondary outcomes (6)
Satisfaction With Disease Status- PESS
The Patient Experienced Symptom State (PESS), evaluates the degree of satisfaction of the patients with the status of RA during the last week, through a single item rated on a 5-level Likert scale response ('very bad', 'bad', 'acceptable', 'good' and 'very good').
Measured: Week 32
Perceived Impact of the Disease
Assessed through the Rheumatoid Arthritis Impact of Disease (RAID) score and its individual domains (RAID.7). The RAID is a 7-item patient-derived measure designed to evaluate the perceived impact of RA upon important health-related domains, namely pain, functional disability, fatigue, sleep, physical well-being, emotional well-being, and coping. The items are rated using 11-points numeric rating scales (0 to 10). Domains can be combined into a single score (RAID) or used separately (RAID.7). Higher scores indicate greater impact of disease.
Measured: Week 32
Anxiety and Depression Levels
Assessed through the Hospital Anxiety Depression Scale (HADS). This scale comprises 14 items, rated on a 4-point Likert scale, aimed at screening for the presence and severity of anxiety and depressive symptoms in the last 7 days. The score range between 0-21 for each condition, with higher values are indicative of more severe levels of symptoms, with a cut-off score of 11 being indicative of a probable diagnosis of depressive major episode.
Measured: Week 32
Self-Compassion
Self-compassion will be assessed by the Self-Compassion Scale (SCS). This 12-item measure is a shorter form of the original scale developed and aims to assess the type of relationship one establishes with oneself in the face of setbacks or difficult times. Items are rated on a 5-point Likert scale. Total score is calculated through the average of the 12 items, ranging from 1 to 5, with greater values indicating greater levels of self-compassion.
Measured: Week 32
Affective Mindfulness
Active Mindfulness will be assessed through the Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT) is a 23-itens self-report measure aimed at assessing psychological flexibility. Items are rated using a 7-point response scale from 0 ('Strongly disagree') to 7 ('Strongly agree'). The scale comprises 3 factors, namely: openness to experience, behavioral awareness and valued action. Scores range from 0-60 (openness to experience subscale), 0-30 (behavioral awareness subscale), 0-48 (valued action subscale), and 0-138 (total score), and are computed by summing all respective items. Higher scores indicate greater psychological flexibility.
Measured: Week 32
Adverse Events
Safety-related outcomes will be evaluated through participants' reporting of adverse events
Measured: Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Sep 2024 (estimated)
- Primary completion15 Feb 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unidade Local de Saúde de Coimbra, EPE
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José António Pereira da Silva, Unidade Local de Saúde de Coimbra, EPE
- Investigators
- Jose AP daSilva, PhD, Principal investigator, CHUC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389189
- Sponsor's protocol ID
- OBS.SF.01/2021
- Acronym
- CoMIRA
- Status last verified
- Feb 2024
- First submitted
- 24 Mar 2022
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37803467
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Tailored Psychological Intervention (MITIG.RA) for Managing Fatigue in Rheumatoid Arthritis: Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05389189
- Acronym / sponsor ID
- CoMIRA / OBS.SF.01/2021
- Conditions
- Rheumatoid Arthritis
- Keywords
- Contextual-cognitive behavioural, Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Unidade Local de Saúde de Coimbra, EPEUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 15 Feb 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT Care | Active comparator | Behavioral: Intervention ArmIntervention 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 |
| TAU Care | No intervention | –Usual Care respecting international recommendations for the management of RA. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention ArmThe 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). | Behavioural | CBT Care |
Primary outcome
Fatigue
Time frame: Week 32
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
6 secondary outcomes
Satisfaction With Disease Status- PESS
Time frame: Week 32
Perceived Impact of the Disease
Time frame: Week 32
Anxiety and Depression Levels
Time frame: Week 32
Self-Compassion
Time frame: Week 32
Affective Mindfulness
Time frame: Week 32
Adverse Events
Time frame: Week 32
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Derived from this study: PubMed 37803467Duarte 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose AP daSilva, PhD principal investigator
CHUC
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Arm in people with Rheumatoid Arthritis, run by Unidade Local de Saúde de Coimbra, EPE.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catia Duarte, MD (+351960330278, catiacmduarte@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: Week 32). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05389189, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.