Self-guided Acceptance and Commitment Therapy-based Digital Smartphone Application for Management of Fibromyalgia
- Conditions
- Fibromyalgia
- Interventions
- Device: FM symptom tracking app (FM-ST)Device: Self-guided digital Acceptance and Commitment TherapyBehavioral: Treatment as Usual (TAU)
- Registration Number
- NCT05962437
- Lead Sponsor
- Fundació Sant Joan de Déu
- Brief Summary
Introduction: Fibromyalgia (FM) is a prevalent syndrome that lacks curative treatment, imposing high healthcare and societal costs. The SMART-FM-Spain study investigates the effectiveness, physiological effects, and cost-utility of a self-guided digital intervention (STANZA-Spain) based on Acceptance and Commitment Therapy (ACT) for patients with FM.
Methodology: Six-month, 3-arm randomized controlled trial (RCT) A total of 360 adult individuals meeting the 2016 American College of Rheumatology (ACR) criteria for FM will be recruited mainly at Vall d'Hebron University Hospital (Barcelona, Spain), and will be randomly allocated to one of the three study arms: Treatment as usual (TAU) plus STANZA-Spain, TAU plus digital symptom tracking (FibroST), or TAU. Participants will be assessed at baseline, post-treatment, and 6 month-follow-up. The primary outcome will be functional impairment and secondary outcomes will include patient impression of change, depression-anxiety-stress, and pain catastrophizing, among others constructs relevant to FM. Effectiveness and cost-utility analysis from a societal perspective will be computed, whereas ACT-related constructs, such as psychological flexibility, will be assessed to identify processes of change that will be analyzed with path analyses. Biomarkers will be assessed at baseline and post-treatment including hair cortisol, cortisone, corticosteroid binding globulin (CBG), adrenocorticotropic hormone (ACTH), cortisol in plasma, genotyping of FKBP5 gene polymorphisms, immune-inflammatory markers, and vitamin D levels.
Discussion: This study might represent a significant advancement in the management of FM in Spanish-speaking patients with FM, by examining the effectiveness, physiological effects, and cost-utility of a smartphone-based digital therapeutic with demonstrated empirical support in the United States of America.
- Detailed Description
Main goals of the SMART-FM-SP study The main objectives of this RCT are: To analyze the effectiveness of adding Acceptance and Commitment Therapy via app (STANZA) compared to an active control arm (Fibro Symptom Tracker app -FibroST-) to the treatment as usual (TAU) for patients diagnosed of fibromyalgia; To examine the cost-utility of STANZA from healthcare and societal perspectives; To measure a set of biomarkers alongide the RCT in order to know the physiological underpinnings of the digital intervention STANZA and to identify potential predictors of treatment response.
Smart-FM-SP is a 6-months RCT with three arms: TAU, TAU+STANZA and TAU+FibroST. Therefore, patients in three arms will receive TAU, and FibroACT and FibroST will be complementary treatments to the standard one provided in the public Catalan Health System.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 360
- Fibromyalgia diagnosis according to the 2016 ACR criteria
- Fibromyalgia Impact Questionnaire Revised (FIQR) total score within the range of 35-80 at baseline.
- Willing to maintain their current pain treatment throughout the study.
- Having a smartphone (iOS 12 or higher or Android OS 8 or higher).
- Proficient understanding of Spanish.
- Presence of cognitive impairment according to clinical records.
- Diagnosis of severe medical or mental disorders such as cancer, psychotic disorder, and drug abuse according to medical records.
- Patients at risk of suicide.
- Being pregnant or planning a pregnancy during the study period, or currently breastfeeding.
- Participation in other clinical trials during the study or within the previous 90 days.
- Unable to use a smartphone.
Exclusion criteria for biomarkers substudy (50% of patients in each study arm):
- Comorbid rheumatologic disorders such as lupus.
- History of fever (> 38ºC), or infection within the last 2 weeks.
- Recent vaccination within the last 4 weeks.
- Needle phobia.
- Consumption of more than 8 units of caffeine per day.
- Smoking more than 5 cigarettes per day.
- Having hair length less than 3 cm.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description STANZA-Spain Treatment as Usual (TAU) Digital Acceptance and Commitment Terapy (ACT). It consists of 41 structured ACT lessons, incorporating mindfulness practices and daily activities to facilitate behavior change and promote gradual pacing of daily activities and exercise. The core content was designed to be completed within 8 weeks, with a 4-week maintenance period thereafter to strengthen skills. FibroST-Spain FM symptom tracking app (FM-ST) A digital active control intervention is implemented to control for study engagement, expectations, and healthcare provider interaction biases. Components of this active comparator include daily symptom and function tracking (Daily Symptom Tracker), symptom and function monitoring, and access to health education articles about fibromyalgia. FibroST-Spain Treatment as Usual (TAU) A digital active control intervention is implemented to control for study engagement, expectations, and healthcare provider interaction biases. Components of this active comparator include daily symptom and function tracking (Daily Symptom Tracker), symptom and function monitoring, and access to health education articles about fibromyalgia. STANZA-Spain Self-guided digital Acceptance and Commitment Therapy Digital Acceptance and Commitment Terapy (ACT). It consists of 41 structured ACT lessons, incorporating mindfulness practices and daily activities to facilitate behavior change and promote gradual pacing of daily activities and exercise. The core content was designed to be completed within 8 weeks, with a 4-week maintenance period thereafter to strengthen skills. Treatment as Usual (TAU) Treatment as Usual (TAU) Usual care is mainly carried out by general practitioners and rheumatologists through regular consultations. Clinicians prescribe medications and provide some counselling.
- Primary Outcome Measures
Name Time Method Fibromyalgia Impact Questionnaire Revised (FIQR) Through study completion, an average of 6 months The FIQR includes 21 items that are answered on a 0-10 numerical scale in which higher scores indicate greater functional impairment. The FIQR assesses the impact of FM symptoms over the past 7 days. The questionnaire consists of items that cover three domains: physical impairment, overall impact, and symptom severity. These items inquire about various aspects such as pain, energy levels, stiffness, sleep quality, depression, memory problems, anxiety, sensitivity to touch, balance issues, and heightened sensitivity to noises, lights, smells, or temperatures. The total FIQR score is calculated by summing the scores of the three subscales, resulting in a range of 0 to 100. Higher scores indicate a greater level of impairment. The Spanish version of the FIQR has an excellent internal consistency (α = 0.91-0.95)
- Secondary Outcome Measures
Name Time Method The Patient Global Impression of Change (PGIC) and the Pain Specific Impression of Change (PSIC) At 3-months follow-up This instrument is an indicator of meaningful clinical change in treatments for chronic pain. The PGIC is one item (on a 7-point numerical scale, from 1 = 'Much better' to 7 = 'Much worse') referred to the participants' perception of global improvement due to treatment. It has undergone validation in the context of psychologically-based treatments for chronic pain. Additionally, the PSIC evaluates (also on a 7-point Likert scale) changes in specific domains, including physical and social functioning, work-related activities, mood, and pain. Both the PGIC \& PSIC scales will be completed by participants assigned to STANZA and FM-ST treatments.
The Depression Anxiety Stress Scales-21 (DASS-21) Through study completion, an average of 6 months It discriminates between features of depression, anxiety and stress in clinical and non-clinical samples. Responders are required to indicate the presence of several symptoms over the previous week. Each item is scored from 0 (´Did not apply to me at all over the last week') to 3 ('applied to me very much or most of the time over the past week'). There are 7 items on each of the three subscales: depression, anxiety and stress. Therefore, total scores in each scale can range from 0 to 21, with higher scores indicating more severe levels of depression, anxiety and stress. The Spanish version has excellent psychometric properties.
The Multidimensional Inventory of Subjective Cognitive Impairment (MISCI) Through study completion, an average of 6 months It is a 10-item self-report measure of subjective cognitive dysfunction in FM during the last week. Each item is scored from 1 ('Not at all/Never') to 5 ('Very much/Always') and the total score ranges from 10 to 50. Lower scores indicate higher cognitive dysfunction. The MISCI was developed through classical test theory and item response theory from cognitive functioning item banks developed within the Patient Reported Outcomes Measurement Information System (PROMIS). The Spanish version of the MISCI has excellent internal reliability (α = 0.91)
The Pain Catastrophising Scale (PCS) Through study completion, an average of 6 months Scale of 13 items comprising three dimensions: rumination over pain, magnification of pain and helplessness in the face of pain symptoms. The PCS total score and subscale scores are computed as the sum of ratings for each item.
This study uses the total score, which can vary from 0 to 52 with higher scores indicating greater pain catastrophising.
Trial Locations
- Locations (2)
Parc Sanitari Sant Joan de Déu (PSSJD)
🇪🇸Sant Boi De Llobregat, Barcelona, Spain
Hospital Vall d'Hebrón
🇪🇸Barcelona, Spain