Self-guided Acceptance and Commitment Therapy-based Digital Smartphone Application for Management of Fibromyalgia

Condition(s) studied

Investigational drug(s) / intervention(s)

Self-guided digital Acceptance and Commitment Therapy: Smartphone-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): Based 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): Usual 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)

Study 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.

Eligibility

Primary outcome measure(s)

• 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)

Trial sites (2)

More Fundació Sant Joan de Déu trials in Spain

Other trials for the same condition