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.
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).
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.
Parallel
Self-guided digital Acceptance and Commitment Therapy
DeviceSmartphone-based mobile health application (app) that delivers a self-guided, evidence-based ACT program tailored to the management of FM. This investigational digital therapeutic, referred to herein as STANZA, was inspired by a web-based ACT program for FM validated by University of Manitoba and was recently granted De Novo clearance by the U.S. FDA. The app delivers ACT in 15- to 20-minute daily doses over the course of 12 weeks with minimal involvement of healthcare providers. The program consists of interactive educational materials that teach ACT skills which are reinforced experientially via values exploration and identification, mindfulness, and relaxation exercises. Values-based assignments follow each lesson to assist patients in incorporating ACT skills into their daily lives. Uniquely, STANZA teaches additional skills, including self-guided physical exercise and pacing daily activities via a personally customized stepwise, gradual approach.
FM symptom tracking app (FM-ST)
DeviceBased on the same platform as STANZA, FM-ST enables self-guided daily tracking of patient-reported symptoms and functioning. Symptom tracking is commonly used in chronic pain management. FM-ST also provides access to educational materials relevant to FM and general health but does not provide any psychotherapy or healthcare professional involvement. This app mitigates potential expectation, treatment time and attention, and healthcare provider interaction biases that often occur in chronic pain studies that utilize passive comparison conditions.
Treatment as Usual (TAU)
BehavioralUsual care is mainly carried out by general practitioners and specialists in regular consultations, commonly consisting of face-to-face visits to monitor the physical and emotional status of the patient. Clinicians usually provide advice about physical exercise, diet, etc., and prescribe pharmacotherapy (pain medications, hypnotics and antidepressants)
Fibromyalgia Impact Questionnaire Revised (FIQR)
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)
The Patient Global Impression of Change (PGIC) and the Pain Specific Impression of Change (PSIC)
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)
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)
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)
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.
Psychological Inflexibility in Pain Scale (PIPS)
12-item scale that assesses psychological inflexibility in patients with pain and includes two factors: avoidance and cognitive fusion with pain. For this study, only the total score is used; it ranges from 12 to 84, with higher scores indicating higher level of psychological inflexibility.
Psy-Flex
This brief 6-item questionnaire assesses psychological flexibility during the past week. It is based on the Acceptance and Commitment Therapy model (ACT; Hayes et al.), which identifies six core dimensions of psychological flexibility: acceptance, cognitive defusion, contact with the present moment, self-as-context, values, and committed action. Each item is answered on a 5-point Likert scale, ranging from 1 ("very rarely") to 5 ("very frequently"). The total score is obtained by summing the responses of the six items; higher scores reflect a higher level of psychological flexibility.
Chronic Pain Acceptance Questionnaire (CPAQ-8)
This scale is composed of 12 items and it measures measure psychological inflexibility in people with chronic pain. It consists of two subscales: avoidance and cognitive fusion in relation to pain. Each item is answered on a 7-point Likert scale, where 1 means "never true" and 7 "always true". The total score ranges between 12 and 84, and higher scores indicate a greater degree of psychological inflexibility.
EuroQoL (EQ-5D-5L)
Instrument for evaluating health-related quality of life. The EQ-5D-5L scores will be used to calculate the Quality-Adjusted Life Years (QALYs) for the cost-utility analysis
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Fundació Sant Joan de Déu
Lead sponsor
Swing Therapeutics, Inc.
Collaborator
