NCT05962437: SMART-FM-SP

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

Status unknown NA Last updated 27 July 2023

What this trial tests

NA trial testing Self-guided digital Acceptance and Commitment Therapy in Fibromyalgia in 360 participants. Status unknown.

Timeline

1 January 2024

Primary endpoint
30 June 2025

31 December 2025

Quick facts

Lead sponsor	Fundació Sant Joan de Déu
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	360
Start date	1 January 2024
Primary completion	30 June 2025
Estimated completion	31 December 2025
Sites	2 locations across Spain

Drugs / interventions tested

• Self-guided digital Acceptance and Commitment Therapy
• FM symptom tracking app (FM-ST)
• Treatment as Usual (TAU) — full drug profile →

Conditions studied

• Fibromyalgia — all drugs for Fibromyalgia →

Sponsor

Fundació Sant Joan de Déu — full company profile →

Who can join

Adults 18 to 70, any sex, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The efficacy, acceptability and safety of acceptance and commitment therapy for fibromyalgia - a systematic review and meta-analysis.
   Eastwood F, Godfrey E. · · 2024 · cited 12× · PMID 38751564 · DOI 10.1177/20494637231221451
2. 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 Commitment Therapy for Spanish patients with fibromyalgia.
   Gallego A, Serrat M, Royuela-Colomer E, Sanabria-Mazo JP, et al · · 2024 · PMID 38550263 · DOI 10.1177/20552076241239177