Three-arm Randomized Controlled Trial Investigating the Effectiveness, Cost-utility, and Physiological Effects of the Spanish Version of STANZA®: A Self-guided Digital Acceptance and Commitment Therapy (ACT) for Fibromyalgia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Fundació Sant Joan de Déu
- Enrollment
- 360
- Locations
- 4
- Primary Endpoint
- Fibromyalgia Impact Questionnaire Revised (FIQR)
Study Overview
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 at Vall d'Hebron University Hospital (Barcelona, Spain), The Rheumatology Service of the Parc Sanitari Sant Joan de Déu (Sant Boi, Spain), The San Juan de Dios Hospital of Palma (Palma de Mallorca, Spain) and The San Juan de Dios Hospital of Aljarafe (Sevilla, Spain). They 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, as measured by the FIQR; 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. Immune-inflamatory biomarkers will be assessed at baseline and post-treatment in 30-40 participants of each study arm. Additionally, a qualitative substudy using focus group thematic analysis will be conducted to deepen the understanding of STANZA app user experiences.
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 immune-inflmmatory biomarkers alongside 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 Health System.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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 12 months.
- •Unable to use a smartphone.
- •Exclusion criteria for biomarkers substudy (30-50 patients in each study arm):
- •Comorbid rheumatologic disorders such as lupus or severe organ dysfunction.
- •History of fever (> 38ºC) or infection within the last 2 weeks.
- •Vaccination within the last 4 weeks.
- •Recent physical trauma
- •Needle phobia.
- •Consumption of more than 8 units of caffeine per day.
- •Smoking more than 5 cigarettes per day.
- •Current use of oral or topical corticosteroids.
- •Current use of anti-cytokine biologic medications.
- •Current use of oral contraceptives.
Arms & Interventions
STANZA-Spain
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.
Intervention: Self-guided digital Acceptance and Commitment Therapy (Device)
STANZA-Spain
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.
Intervention: Treatment as Usual (TAU) (Behavioral)
FibroST-Spain
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.
Intervention: Treatment as Usual (TAU) (Behavioral)
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.
Intervention: Treatment as Usual (TAU) (Behavioral)
FibroST-Spain
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.
Intervention: FM symptom tracking app (FM-ST) (Device)
Outcomes
Primary Outcomes
Fibromyalgia Impact Questionnaire Revised (FIQR)
Time Frame: 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 Outcomes
- The Patient Global Impression of Change (PGIC) and the Pain Specific Impression of Change (PSIC)(At 3-months follow-up)
- The Depression Anxiety Stress Scales-21 (DASS-21)(Through study completion, an average of 6 months)
- The Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)(Through study completion, an average of 6 months)
- The Pain Catastrophising Scale (PCS)(Through study completion, an average of 6 months)
- The Patient Global Impression of Change (PGIC) and the Pain Specific Impression of Change (PSIC)(At 3 and 6-months follow-up)