Clinical trial NCT05962437: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Swing Therapeutics, Inc.
First posted: 2023-07-27
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

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 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.

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire Revised (FIQR)
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: The Patient Global Impression of Change (PGIC) and the Pain Specific Impression of Change (PSIC)
timeFrame: At 3-months follow-up
measure: The Depression Anxiety Stress Scales-21 (DASS-21)
timeFrame: Through study completion, an average of 6 months
measure: The Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)
timeFrame: Through study completion, an average of 6 months
measure: The Pain Catastrophising Scale (PCS)
timeFrame: Through study completion, an average of 6 months
Other outcomes:
measure: Psychological Inflexibility in Pain Scale (PIPS)
timeFrame: Through study completion, an average of 6 months.
measure: EuroQoL (EQ-5D-5L)
timeFrame: Through study completion, an average of 6 months
measure: Credibility/Expectancy questionnaire (CEQ)
timeFrame: Baseline
measure: Client Service Receipt Inventory (CSRI)
timeFrame: Through study completion, an average of 6 months
measure: Adverse effects of therapies
timeFrame: Through study completion, an average of 6 months
measure: Socio-demographic and clinical questionnaire
timeFrame: Baseline
measure: Immune biomarkers
timeFrame: Baseline and 3-months follow-up
measure: Hair cortisol and cortisone, serum cortisol, corticosteroid-binding globulin (CBG) and vitamin D.
timeFrame: Baseline and 3-months follow-up
measure: Polymorphisms in the FKBP5 gene
timeFrame: Baseline
Locations:
city: Sant Boi De Llobregat
country: Spain
facility: Parc Sanitari Sant Joan de Déu (PSSJD)
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebrón
Study officials:
affiliation: Universitat Autònoma de Barcelona (UAB) & FSJD
name: Juan V Luciano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.