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

NCT05962437 | Unknown

• 1 other identifier: PI22/00829
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• 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)

  Through study completion, an average of 6 months

Secondary Outcomes (4)

• 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

Other Outcomes (9)

• Psychological Inflexibility in Pain Scale (PIPS)

  Through study completion, an average of 6 months.

• EuroQoL (EQ-5D-5L)

  Through study completion, an average of 6 months

• Credibility/Expectancy questionnaire (CEQ)

  Baseline

Study Arms (3)

STANZA-Spain

EXPERIMENTAL

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.

Device: Self-guided digital Acceptance and Commitment Therapy; Behavioral: Treatment as Usual (TAU)

FibroST-Spain

ACTIVE COMPARATOR

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.

Device: FM symptom tracking app (FM-ST); Behavioral: Treatment as Usual (TAU)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Usual care is mainly carried out by general practitioners and rheumatologists through regular consultations. Clinicians prescribe medications and provide some counselling.

Behavioral: Treatment as Usual (TAU)

Interventions

Self-guided digital Acceptance and Commitment Therapy DEVICE

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 without the 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.

STANZA-Spain

FM symptom tracking app (FM-ST) DEVICE

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.

FibroST-Spain

Treatment as Usual (TAU) BEHAVIORAL

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)

FibroST-Spain; STANZA-Spain; Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead
• Swing Therapeutics, Inc.: collaborator

Study Sites (2)

Parc Sanitari Sant Joan de Déu (PSSJD)

Sant Boi de Llobregat, Barcelona, 08830, Spain

Location

Hospital Vall d'Hebrón

Barcelona, 08035, Spain

Location

Related Publications (1)

• Catella S, Gendreau RM, Kraus AC, Vega N, Rosenbluth MJ, Soefje S, Malhotra S, Luciano JV, McCracken LM, Williams DA, Arnold LM. Self-guided digital acceptance and commitment therapy for fibromyalgia management: results of a randomized, active-controlled, phase II pilot clinical trial. J Behav Med. 2024 Feb;47(1):27-42. doi: 10.1007/s10865-023-00429-3. Epub 2023 Jun 29.

  PMID: 37382794 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Juan V Luciano, PhD

  Universitat Autònoma de Barcelona (UAB) & FSJD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaime Navarrete, PhD

CONTACT

+34936406350; jaime.navarrete@sjd.es

Mayte Serrat, PhD

CONTACT

+34934863000; mayte.serrat@vallhebron.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 27, 2023
• Study Start: January 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)