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

Primary Purpose

Fibromyalgia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Self-guided digital Acceptance and Commitment Therapy
FM symptom tracking app (FM-ST)
Treatment as Usual (TAU)
Sponsored by
Fundació Sant Joan de Déu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Parc Sanitari Sant Joan de Déu (PSSJD)
  • Hospital Vall d'Hebrón

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

STANZA-Spain

FibroST-Spain

Treatment as Usual (TAU)

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

The Patient Global Impression of Change (PGIC) and the Pain Specific Impression of Change (PSIC)
This instrument is an indicator of meaningful clinical change in treatments for chronic pain. The PGIC is one item (on a 7-point numerical scale, from 1 = 'Much better' to 7 = 'Much worse') referred to the participants' perception of global improvement due to treatment. It has undergone validation in the context of psychologically-based treatments for chronic pain. Additionally, the PSIC evaluates (also on a 7-point Likert scale) changes in specific domains, including physical and social functioning, work-related activities, mood, and pain. Both the PGIC & PSIC scales will be completed by participants assigned to STANZA and FM-ST treatments.
The Depression Anxiety Stress Scales-21 (DASS-21)
It discriminates between features of depression, anxiety and stress in clinical and non-clinical samples. Responders are required to indicate the presence of several symptoms over the previous week. Each item is scored from 0 (´Did not apply to me at all over the last week') to 3 ('applied to me very much or most of the time over the past week'). There are 7 items on each of the three subscales: depression, anxiety and stress. Therefore, total scores in each scale can range from 0 to 21, with higher scores indicating more severe levels of depression, anxiety and stress. The Spanish version has excellent psychometric properties.
The Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)
It is a 10-item self-report measure of subjective cognitive dysfunction in FM during the last week. Each item is scored from 1 ('Not at all/Never') to 5 ('Very much/Always') and the total score ranges from 10 to 50. Lower scores indicate higher cognitive dysfunction. The MISCI was developed through classical test theory and item response theory from cognitive functioning item banks developed within the Patient Reported Outcomes Measurement Information System (PROMIS). The Spanish version of the MISCI has excellent internal reliability (α = 0.91)
The Pain Catastrophising Scale (PCS)
Scale of 13 items comprising three dimensions: rumination over pain, magnification of pain and helplessness in the face of pain symptoms. The PCS total score and subscale scores are computed as the sum of ratings for each item. This study uses the total score, which can vary from 0 to 52 with higher scores indicating greater pain catastrophising.

Full Information

First Posted
July 18, 2023
Last Updated
July 18, 2023
Sponsor
Fundació Sant Joan de Déu
Collaborators
Swing Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05962437
Brief Title
Self-guided Acceptance and Commitment Therapy-based Digital Smartphone Application for Management of Fibromyalgia
Acronym
SMART-FM-SP
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Sant Joan de Déu
Collaborators
Swing Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STANZA-Spain
Arm Type
Experimental
Arm 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.
Arm Title
FibroST-Spain
Arm Type
Active Comparator
Arm 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.
Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
Usual care is mainly carried out by general practitioners and rheumatologists through regular consultations. Clinicians prescribe medications and provide some counselling.
Intervention Type
Device
Intervention Name(s)
Self-guided digital Acceptance and Commitment Therapy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
FM symptom tracking app (FM-ST)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual (TAU)
Intervention Description
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 Measure Information:
Title
Fibromyalgia Impact Questionnaire Revised (FIQR)
Description
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)
Time Frame
Through study completion, an average of 6 months
Secondary Outcome Measure Information:
Title
The Patient Global Impression of Change (PGIC) and the Pain Specific Impression of Change (PSIC)
Description
This instrument is an indicator of meaningful clinical change in treatments for chronic pain. The PGIC is one item (on a 7-point numerical scale, from 1 = 'Much better' to 7 = 'Much worse') referred to the participants' perception of global improvement due to treatment. It has undergone validation in the context of psychologically-based treatments for chronic pain. Additionally, the PSIC evaluates (also on a 7-point Likert scale) changes in specific domains, including physical and social functioning, work-related activities, mood, and pain. Both the PGIC & PSIC scales will be completed by participants assigned to STANZA and FM-ST treatments.
Time Frame
At 3-months follow-up
Title
The Depression Anxiety Stress Scales-21 (DASS-21)
Description
It discriminates between features of depression, anxiety and stress in clinical and non-clinical samples. Responders are required to indicate the presence of several symptoms over the previous week. Each item is scored from 0 (´Did not apply to me at all over the last week') to 3 ('applied to me very much or most of the time over the past week'). There are 7 items on each of the three subscales: depression, anxiety and stress. Therefore, total scores in each scale can range from 0 to 21, with higher scores indicating more severe levels of depression, anxiety and stress. The Spanish version has excellent psychometric properties.
Time Frame
Through study completion, an average of 6 months
Title
The Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)
Description
It is a 10-item self-report measure of subjective cognitive dysfunction in FM during the last week. Each item is scored from 1 ('Not at all/Never') to 5 ('Very much/Always') and the total score ranges from 10 to 50. Lower scores indicate higher cognitive dysfunction. The MISCI was developed through classical test theory and item response theory from cognitive functioning item banks developed within the Patient Reported Outcomes Measurement Information System (PROMIS). The Spanish version of the MISCI has excellent internal reliability (α = 0.91)
Time Frame
Through study completion, an average of 6 months
Title
The Pain Catastrophising Scale (PCS)
Description
Scale of 13 items comprising three dimensions: rumination over pain, magnification of pain and helplessness in the face of pain symptoms. The PCS total score and subscale scores are computed as the sum of ratings for each item. This study uses the total score, which can vary from 0 to 52 with higher scores indicating greater pain catastrophising.
Time Frame
Through study completion, an average of 6 months
Other Pre-specified Outcome Measures:
Title
Psychological Inflexibility in Pain Scale (PIPS)
Description
12-item scale that assesses psychological inflexibility in patients with pain and includes two factors: avoidance and cognitive fusion with pain. For this study, only the total score is used; it ranges from 12 to 84, with higher scores indicating higher level of psychological inflexibility.
Time Frame
Through study completion, an average of 6 months.
Title
EuroQoL (EQ-5D-5L)
Description
Instrument for evaluating health-related quality of life. The EQ-5D-5L scores will be used to calculate the Quality-Adjusted Life Years (QALYs) for the cost-utility analysis
Time Frame
Through study completion, an average of 6 months
Title
Credibility/Expectancy questionnaire (CEQ)
Description
6-item questionnaire for measuring treatment expectancy and credibility for use in clinical outcome studies. Each item is rated from 0 to 10, with higher scores indicating better expectancy.
Time Frame
Baseline
Title
Client Service Receipt Inventory (CSRI)
Description
The version used in this study is designed to retrospectively collect information on the use of health and social services during the previous six months. This instrument does not provide total or sub-scale scores, only collects information about use of services and medication consumption.
Time Frame
Through study completion, an average of 6 months
Title
Adverse effects of therapies
Description
Qualitative ad hoc measure to check the presence of negative effects of the therapies
Time Frame
Through study completion, an average of 6 months
Title
Socio-demographic and clinical questionnaire
Description
Gender, date of birth, marital status, living arrangements, educational level, employment status, and years lived with fibromyalgia
Time Frame
Baseline
Title
Immune biomarkers
Description
Serum levels of IL-4, IL-6, CXCL8, IL-10, IL-17A, brain-derived neurotrophic factor (BDNF), and high sensitivity C-reactive protein (hs-CRP)
Time Frame
Baseline and 3-months follow-up
Title
Hair cortisol and cortisone, serum cortisol, corticosteroid-binding globulin (CBG) and vitamin D.
Description
Biomarkers associated with HPA-axis functioning
Time Frame
Baseline and 3-months follow-up
Title
Polymorphisms in the FKBP5 gene
Description
Genetic variants of the FKBP5 gene. Five proposed SNP polymorphisms in the FKBP5 gene [rs3800373 (SNP1), rs9296158 (SNP2), rs1360780 (SNP3), rs9470080 (SNP4) and rs4713916 (SNP5)].
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaime Navarrete, PhD
Phone
+34936406350
Ext
2543
Email
jaime.navarrete@sjd.es
First Name & Middle Initial & Last Name or Official Title & Degree
Mayte Serrat, PhD
Phone
+34934863000
Ext
3361
Email
mayte.serrat@vallhebron.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan V Luciano, PhD
Organizational Affiliation
Universitat Autònoma de Barcelona (UAB) & FSJD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parc Sanitari Sant Joan de Déu (PSSJD)
City
Sant Boi De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08830
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan V Luciano, PhD
Phone
+34936406350
Ext
2540
Email
juanvicente.luciano@sjd.es
First Name & Middle Initial & Last Name & Degree
Antoni Rozadilla-Sacanell, MD, PhD
Phone
+34936615208
Email
antoni.rozadilla@sjd.es
First Name & Middle Initial & Last Name & Degree
Juan V Luciano, PhD
First Name & Middle Initial & Last Name & Degree
Antoni Rozadilla-Sacanell, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jaime Navarrete-Hidalgo, PhD
First Name & Middle Initial & Last Name & Degree
Juan P Sanabria-Mazo, MSc
First Name & Middle Initial & Last Name & Degree
Ariadna Colomer-Carbonell, MSc
Facility Name
Hospital Vall d'Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mayte Serrat, PhD
Phone
+34934863000
Ext
3361
Email
mayte.serrat@vallhebron.cat
First Name & Middle Initial & Last Name & Degree
Mayte Serrat, PhD
First Name & Middle Initial & Last Name & Degree
Miriam Almirall, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
37382794
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. 2023 Jun 29. doi: 10.1007/s10865-023-00429-3. Online ahead of print.
Results Reference
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Self-guided Acceptance and Commitment Therapy-based Digital Smartphone Application for Management of Fibromyalgia

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