Administrative information
Title {1} | MITIG.RA: study protocol of a tailored psychological intervention for managing fatigue in rheumatoid arthritis randomized controlled trial |
Trial registration {2a and 2b} | ClinicalTrials.gov NCT05389189. Registered on May 25, 2022, before the start of inclusion. |
Protocol version {3} | Protocol version 2, May 1, 2022 |
Funding {4} | The study has no monetary funding |
Author details {5a} | Cátia Duarte*, 1,2 Ruben L.F. Spilker,*3 Cláudia Paiva,1 Ricardo J.O. Ferreira,4 José A. Pereira da Silva,** 1,2 Ana M. Pinto**,5,6 Affiliations 1 Rheumatology Department, Centro Hospitalar e Universitário de Coimbra, Portugal. 2 Coimbra Institute for Clinical and Biomedical Research (iCBR), Faculty of Medicine, University of Coimbra, Portugal 3Faculty of Medicine, University of Coimbra, Portugal. 4 Nursing Research, Innovation and Development Centre of Lisbon (CIDNUR), Nursing School of Lisbon (ESEL), Portugal 5 Centre for Research in Neuropsychology and Cognitive and Behavioural Intervention (CINEICC), Faculty of Psychology and Educational Sciences, University of Coimbra, Portugal. 6 Institute of Psychological Medicine, Faculty of Medicine University of Coimbra, Portugal. * and **Contributed equally to this paper |
Name and contact information for the trial sponsor {5b} | The study has no sponsor |
Role of sponsor {5c} | The study has no sponsor |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods: participants, interventions and outcomes
Study setting {9}
Eligibility criteria {10}
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Intervention content
Session | Module | Content and learning objectives |
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Session 1 | Psychoeducation | • Introduction to the programme: goals, overview, and ground rules |
• Participants’ presentation, motivations to participate, and expectations about the intervention | ||
• Identification of current difficulties in dealing with fatigue, prior coping attempts, and their costs-benefits—creative hopelessness | ||
• Psychoeducation about RA and fatigue (e.g. ‘drivers’ and ‘feeders’ of fatigue)—the importance of healthy lifestyle habits (sleep hygiene, physical activity, stress, and pacing) | ||
Session 2 | Psychoeducation and mindfulness skills development | • Psychoeducation about the body-mind link, the function of the mind, and its patterns |
• Promoting mindfulness skills and body awareness • Introducing mindfulness in daily life: | ||
• informal practice | ||
Session 3 | Mindfulness skills development | • Promoting mindfulness skills and body awareness |
• Interoceptive exposure | ||
• Get to know your ‘judgy’ mind | ||
Session 4 | Promoting acceptance | • Control as a never-ending source of suffering |
• Learning to ‘unhook’ and making room for discomfort | ||
Session 5 | Self-compassion | • Cultivating compassion towards others, with a special focus on kindness |
• Compassion from others: an ally or an enemy? | ||
• Exploring new ways of communicating effectively | ||
Session 6 | Self-compassion and loving kindness | • What is compassion got to do with it—compassion flows and compassion towards the self |
• Bringing compassion to the body | ||
• Fostering a different form of self-self and self-other relating | ||
Session 7 | Values and committed action | • Living a meaningful life (values work, identification of ‘drainers’ and ‘energizers’, values-based goals setting) |
• Step-by-step action planning | ||
• Identification of barriers and facilitators to committed action (reinforce the importance of pacing) | ||
Session 8 | Closing session | • Review of the key concepts and take-home messages |
• Identification and discussion of potential setbacks and strategies to deal with them | ||
• Feedback on the intervention and progress made attending to the initial expectations | ||
Follow-up after 2 and 4 months | Booster sessions | • Refreshment of the main concepts; evaluate difficulties in the implementation and/or practice of learned skills; revisit and consolidate mindfulness, acceptance, and compassion exercises from the sessions |
Implementation
Fidelity assessment
Treatment as usual (TAU)
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Primary outcome
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Fatigue: Fatigue levels will be assessed by the 0–10 numerical rating scale assessing fatigue as part of the RAID [54], described below. Changes at the 3-month follow-up after the second booster session, i.e. 32nd week will be considered.
Secondary outcomes
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Satisfaction with disease status—PESS: The Patient Experienced Symptom State (PESS) [56] evaluates the patients’ degree of satisfaction with their RA status during the last week, through a single item rated on a 5-level Likert scale response (‘very bad’, ‘bad’, ‘acceptable’, ‘good’, and ‘very good’).
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Perceived impact of disease—RAID and RAID.7: The RAID is a 7-item patient-derived measure designed to evaluate the patients’ 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-point numeric rating scales. Domains can be combined into a single score (RAID) [55, 62] or used separately (RAID.7) [54]. Higher scores indicate a greater impact of disease.
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Anxiety and depression—HADS: Levels of emotional distress will be measured through the Hospital Anxiety and Depression Scale [63, 64]. 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. Higher values are indicative of more severe levels of symptoms, with a cut-off score of 11 being indicative of a clinically significant mood/anxiety disorder.
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Self-compassion—SCS-sv: Self-compassion will be assessed by the Self-Compassion Scale [65, 66]. This 12-item measure is a shorter form of the original scale developed by Neff [67] 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, with greater values indicating greater levels of self-compassion. While several factorial solutions have been proposed, in this study, we will use a two-factor structure, comprising the self-compassionate attitude subscale and the self-critical attitude subscale.
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Psychological flexibility—CompACT: Psychological flexibility, a key construct in ACT, will be assessed through the Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT) [68]. This is a 23-item self-report measure rated using a 7-point response scale from 0 (‘strongly disagree’) to 7 (‘strongly agree’). The scale comprises 3 factors, namely openness to experience (e.g. ‘I can take thoughts and feelings as they come, without attempting to control or avoid them’), behavioural awareness (e.g. ‘I do jobs or tasks automatically, without being aware of what I am doing’), and valued action (e.g. ‘I can identify the things that really matter to me in life and pursue them’). Scores range from 0 to 60 (openness to experience subscale), 0 to 30 (behavioural awareness subscale), 0 to 48 (valued action subscale), and 0 to 138 (total score) and are computed by summing all respective items. Higher scores indicate greater psychological flexibility.
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Patient global assessment of disease activity—PGA: In our study, the PGA will not be used as an outcome measure but as a tool used to define eligibility. PGA is one of the most widely used patient-reported outcomes in RA and is found in several scores, such as the 28-Joint Disease Activity Score (DAS-28). The PGA is a holistic assessment of disease that goes beyond the objective measures of inflammation (acute phase reactants) and/or structural damage (radiographic) [66, 69]Clique ou toque aqui para introduzir texto.. Higher scores represent a higher level of disease activity or a worse global health, since the proposed definition of ‘low global assessment’ is ≤ 2.0 on a 0 to 10 scale [70].
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Safety of the intervention: Safety-related outcomes will be evaluated through participants’ reporting of adverse events and will include information regarding the nature/type of adverse event, duration and frequency of the event, and degree of association with the intervention (‘no’, ‘probably’, ‘possibly’, ‘yes’).
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Feasibility and acceptability: Feasibility will not be formally assessed in this study as they seem well-established in the literature regarding similar interventions in similar contexts [51, 61]. However, all aspects related to these dimensions will be proactively monitored and registered, namely through rates of attendance and drop-out and the respective underlying reasons.