Self-guided Acceptance and Commitment Therapy-based Digital Smartphone Application for Management of Fibromyalgia (SMART-FM-SP)

Fundació Sant Joan de Déu

Status: Not yet enrolling

Conditions: Fibromyalgia

Treatments: Behavioral: Treatment as Usual (TAU); Device: Self-guided digital Acceptance and Commitment Therapy; Device: FM symptom tracking app (FM-ST)

Study type: Interventional

Funder types: Other

Identifiers

NCT05962437

PI22/00829

Details and patient eligibility

About

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.

Full 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 biomarkers alongide 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 Catalan Health System.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 90 days.
• Unable to use a smartphone.

Exclusion criteria for biomarkers substudy (50% of patients in each study arm):

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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360 participants in 3 patient groups

STANZA-Spain

Experimental group

Description:

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.

Treatment:

Behavioral: Treatment as Usual (TAU)

Device: Self-guided digital Acceptance and Commitment Therapy

FibroST-Spain

Active Comparator group

Description:

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.

Treatment:

Device: FM symptom tracking app (FM-ST)

Behavioral: Treatment as Usual (TAU)

Treatment as Usual (TAU)

Active Comparator group

Description:

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

Treatment:

Behavioral: Treatment as Usual (TAU)