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

Official title

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

Overview

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.

Interventions

• Device 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 con
• Device 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
• Behavioral 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)

Primary outcome measures

• Fibromyalgia Impact Questionnaire Revised (FIQR) [Time frame: Through study completion, an average of 6 months]

Secondary outcome measures (4)

• The Patient Global Impression of Change (PGIC) and the Pain Specific Impression of Change (PSIC) [Time frame: At 3 and 6-months follow-up]
• The Depression Anxiety Stress Scales-21 (DASS-21) [Time frame: Through study completion, an average of 6 months]
• The Multidimensional Inventory of Subjective Cognitive Impairment (MISCI) [Time frame: Through study completion, an average of 6 months]
• The Pain Catastrophising Scale (PCS) [Time frame: Through study completion, an average of 6 months]

Eligibility criteria

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):

• Male sex
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Spain · 2 centers

• Hospital Vall d'Hebrón — Barcelona
• Parc Sanitari Sant Joan de Déu (PSSJD) — Sant Boi de Llobregat

Publications

• Gallego A, Serrat M, Royuela-Colomer E, Sanabria-Mazo JP, Borras X, Esteve M, Grasa M, Rosa A, Rozadilla-Sacanell A, Almirall M, D'Amico F, Dai Y, Rosenbluth MJ, McCracken LM, Navarrete J, Feliu-Soler A, Luciano JV. Study protocol for a three-arm randomized controlled trial investigating the effectiveness, cost-utility, and physiological effects of a fully self-guided digital Acceptance and Commit PMID 38550263

Identifiers

NCT: NCT05962437 · PI22/00829

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗