xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05962437</url>
    </required_header>
    <id_info>
      <org_study_id>PI22/00829</org_study_id>
      <nct_id>NCT05962437</nct_id>
    </id_info>
    <brief_title>Self-guided Acceptance and Commitment Therapy-based Digital Smartphone Application for Management of Fibromyalgia</brief_title>
    <acronym>SMART-FM-SP</acronym>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fundació Sant Joan de Déu</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Swing Therapeutics, Inc.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Fundació Sant Joan de Déu</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Introduction: Fibromyalgia (FM) is a prevalent syndrome that lacks curative treatment,&#xD;
        imposing high healthcare and societal costs. The SMART-FM-Spain study investigates the&#xD;
        effectiveness, physiological effects, and cost-utility of a self-guided digital intervention&#xD;
        (STANZA-Spain) based on Acceptance and Commitment Therapy (ACT) for patients with FM.&#xD;
  &#xD;
        Methodology: Six-month, 3-arm randomized controlled trial (RCT) A total of 360 adult&#xD;
        individuals meeting the 2016 American College of Rheumatology (ACR) criteria for FM will be&#xD;
        recruited mainly at Vall d'Hebron University Hospital (Barcelona, Spain), and will be&#xD;
        randomly allocated to one of the three study arms: Treatment as usual (TAU) plus&#xD;
        STANZA-Spain, TAU plus digital symptom tracking (FibroST), or TAU. Participants will be&#xD;
        assessed at baseline, post-treatment, and 6 month-follow-up. The primary outcome will be&#xD;
        functional impairment and secondary outcomes will include patient impression of change,&#xD;
        depression-anxiety-stress, and pain catastrophizing, among others constructs relevant to FM.&#xD;
        Effectiveness and cost-utility analysis from a societal perspective will be computed, whereas&#xD;
        ACT-related constructs, such as psychological flexibility, will be assessed to identify&#xD;
        processes of change that will be analyzed with path analyses. Biomarkers will be assessed at&#xD;
        baseline and post-treatment including hair cortisol, cortisone, corticosteroid binding&#xD;
        globulin (CBG), adrenocorticotropic hormone (ACTH), cortisol in plasma, genotyping of FKBP5&#xD;
        gene polymorphisms, immune-inflammatory markers, and vitamin D levels.&#xD;
  &#xD;
        Discussion: This study might represent a significant advancement in the management of FM in&#xD;
        Spanish-speaking patients with FM, by examining the effectiveness, physiological effects, and&#xD;
        cost-utility of a smartphone-based digital therapeutic with demonstrated empirical support in&#xD;
        the United States of America.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Main goals of the SMART-FM-SP study The main objectives of this RCT are: To analyze the&#xD;
        effectiveness of adding Acceptance and Commitment Therapy via app (STANZA) compared to an&#xD;
        active control arm (Fibro Symptom Tracker app -FibroST-) to the treatment as usual (TAU) for&#xD;
        patients diagnosed of fibromyalgia; To examine the cost-utility of STANZA from healthcare and&#xD;
        societal perspectives; To measure a set of biomarkers alongide the RCT in order to know the&#xD;
        physiological underpinnings of the digital intervention STANZA and to identify potential&#xD;
        predictors of treatment response.&#xD;
  &#xD;
        Smart-FM-SP is a 6-months RCT with three arms: TAU, TAU+STANZA and TAU+FibroST. Therefore,&#xD;
        patients in three arms will receive TAU, and FibroACT and FibroST will be complementary&#xD;
        treatments to the standard one provided in the public Catalan Health System.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Fibromyalgia Impact Questionnaire Revised (FIQR)</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <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)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The Patient Global Impression of Change (PGIC) and the Pain Specific Impression of Change (PSIC)</measure>
      <time_frame>At 3-months follow-up</time_frame>
      <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 &amp; PSIC scales will be completed by participants assigned to STANZA and FM-ST treatments.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Depression Anxiety Stress Scales-21 (DASS-21)</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <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)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Pain Catastrophising Scale (PCS)</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <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.&#xD;
  This study uses the total score, which can vary from 0 to 52 with higher scores indicating greater pain catastrophising.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Psychological Inflexibility in Pain Scale (PIPS)</measure>
      <time_frame>Through study completion, an average of 6 months.</time_frame>
      <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.</description>
    </other_outcome>
    <other_outcome>
      <measure>EuroQoL (EQ-5D-5L)</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <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</description>
    </other_outcome>
    <other_outcome>
      <measure>Credibility/Expectancy questionnaire (CEQ)</measure>
      <time_frame>Baseline</time_frame>
      <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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Client Service Receipt Inventory (CSRI)</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Adverse effects of therapies</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Qualitative ad hoc measure to check the presence of negative effects of the therapies</description>
    </other_outcome>
    <other_outcome>
      <measure>Socio-demographic and clinical questionnaire</measure>
      <time_frame>Baseline</time_frame>
      <description>Gender, date of birth, marital status, living arrangements, educational level, employment status, and years lived with fibromyalgia</description>
    </other_outcome>
    <other_outcome>
      <measure>Immune biomarkers</measure>
      <time_frame>Baseline and 3-months follow-up</time_frame>
      <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)</description>
    </other_outcome>
    <other_outcome>
      <measure>Hair cortisol and cortisone, serum cortisol, corticosteroid-binding globulin (CBG) and vitamin D.</measure>
      <time_frame>Baseline and 3-months follow-up</time_frame>
      <description>Biomarkers associated with HPA-axis functioning</description>
    </other_outcome>
    <other_outcome>
      <measure>Polymorphisms in the FKBP5 gene</measure>
      <time_frame>Baseline</time_frame>
      <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)].</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">360</enrollment>
    <condition>Fibromyalgia</condition>
    <arm_group>
      <arm_group_label>STANZA-Spain</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>FibroST-Spain</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment as Usual (TAU)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Usual care is mainly carried out by general practitioners and rheumatologists through regular consultations. Clinicians prescribe medications and provide some counselling.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Self-guided digital Acceptance and Commitment Therapy</intervention_name>
      <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.</description>
      <arm_group_label>STANZA-Spain</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>FM symptom tracking app (FM-ST)</intervention_name>
      <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.</description>
      <arm_group_label>FibroST-Spain</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Treatment as Usual (TAU)</intervention_name>
      <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)</description>
      <arm_group_label>FibroST-Spain</arm_group_label>
      <arm_group_label>STANZA-Spain</arm_group_label>
      <arm_group_label>Treatment as Usual (TAU)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Fibromyalgia diagnosis according to the 2016 ACR criteria&#xD;
  &#xD;
            -  Fibromyalgia Impact Questionnaire Revised (FIQR) total score within the range of 35-80&#xD;
               at baseline.&#xD;
  &#xD;
            -  Willing to maintain their current pain treatment throughout the study.&#xD;
  &#xD;
            -  Having a smartphone (iOS 12 or higher or Android OS 8 or higher).&#xD;
  &#xD;
            -  Proficient understanding of Spanish.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of cognitive impairment according to clinical records.&#xD;
  &#xD;
            -  Diagnosis of severe medical or mental disorders such as cancer, psychotic disorder,&#xD;
               and drug abuse according to medical records.&#xD;
  &#xD;
            -  Patients at risk of suicide.&#xD;
  &#xD;
            -  Being pregnant or planning a pregnancy during the study period, or currently&#xD;
               breastfeeding.&#xD;
  &#xD;
            -  Participation in other clinical trials during the study or within the previous 90&#xD;
               days.&#xD;
  &#xD;
            -  Unable to use a smartphone.&#xD;
  &#xD;
          Exclusion criteria for biomarkers substudy (50% of patients in each study arm):&#xD;
  &#xD;
            -  Comorbid rheumatologic disorders such as lupus.&#xD;
  &#xD;
            -  History of fever (&gt; 38ºC), or infection within the last 2 weeks.&#xD;
  &#xD;
            -  Recent vaccination within the last 4 weeks.&#xD;
  &#xD;
            -  Needle phobia.&#xD;
  &#xD;
            -  Consumption of more than 8 units of caffeine per day.&#xD;
  &#xD;
            -  Smoking more than 5 cigarettes per day.&#xD;
  &#xD;
            -  Having hair length less than 3 cm.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Juan V Luciano, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Universitat Autònoma de Barcelona (UAB) &amp; FSJD</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jaime Navarrete, PhD</last_name>
      <phone>+34936406350</phone>
      <phone_ext>2543</phone_ext>
      <email>jaime.navarrete@sjd.es</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mayte Serrat, PhD</last_name>
      <phone>+34934863000</phone>
      <phone_ext>3361</phone_ext>
      <email>mayte.serrat@vallhebron.cat</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Parc Sanitari Sant Joan de Déu (PSSJD)</name>
        <address>
          <city>Sant Boi De Llobregat</city>
          <state>Barcelona</state>
          <zip>08830</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Juan V Luciano, PhD</last_name>
        <phone>+34936406350</phone>
        <phone_ext>2540</phone_ext>
        <email>juanvicente.luciano@sjd.es</email>
      </contact>
      <contact_backup>
        <last_name>Antoni Rozadilla-Sacanell, MD, PhD</last_name>
        <phone>+34936615208</phone>
        <email>antoni.rozadilla@sjd.es</email>
      </contact_backup>
      <investigator>
        <last_name>Juan V Luciano, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Antoni Rozadilla-Sacanell, MD, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jaime Navarrete-Hidalgo, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Juan P Sanabria-Mazo, MSc</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ariadna Colomer-Carbonell, MSc</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Hospital Vall d'Hebrón</name>
        <address>
          <city>Barcelona</city>
          <zip>08035</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Mayte Serrat, PhD</last_name>
        <phone>+34934863000</phone>
        <phone_ext>3361</phone_ext>
        <email>mayte.serrat@vallhebron.cat</email>
      </contact>
      <investigator>
        <last_name>Mayte Serrat, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Miriam Almirall, MD, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <reference>
      <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.</citation>
      <PMID>37382794</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fibromyalgia</mesh_term>
      <mesh_term>Myofascial Pain Syndromes</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05962437
  org study id: PI22/00829
  nct id: NCT05962437
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  measure: Fibromyalgia Impact Questionnaire Revised (FIQR)
  time frame: Through study completion, an average of 6 months
  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)
  measure: The Patient Global Impression of Change (PGIC) and the Pain Specific Impression of Change (PSIC)
  time frame: At 3-months follow-up
  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.
  measure: The Depression Anxiety Stress Scales-21 (DASS-21)
  time frame: Through study completion, an average of 6 months
  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.
  measure: The Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)
  time frame: Through study completion, an average of 6 months
  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)
  measure: The Pain Catastrophising Scale (PCS)
  time frame: Through study completion, an average of 6 months
  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.
  measure: Psychological Inflexibility in Pain Scale (PIPS)
  time frame: Through study completion, an average of 6 months.
  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.
  measure: EuroQoL (EQ-5D-5L)
  time frame: Through study completion, an average of 6 months
  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
  measure: Credibility/Expectancy questionnaire (CEQ)
  time frame: Baseline
  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.
  measure: Client Service Receipt Inventory (CSRI)
  time frame: Through study completion, an average of 6 months
  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.
  measure: Adverse effects of therapies
  time frame: Through study completion, an average of 6 months
  description: Qualitative ad hoc measure to check the presence of negative effects of the therapies
  measure: Socio-demographic and clinical questionnaire
  time frame: Baseline
  description: Gender, date of birth, marital status, living arrangements, educational level, employment status, and years lived with fibromyalgia
  measure: Immune biomarkers
  time frame: Baseline and 3-months follow-up
  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)
  measure: Hair cortisol and cortisone, serum cortisol, corticosteroid-binding globulin (CBG) and vitamin D.
  time frame: Baseline and 3-months follow-up
  description: Biomarkers associated with HPA-axis functioning
  measure: Polymorphisms in the FKBP5 gene
  time frame: Baseline
  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)].
  arm group label: STANZA-Spain
  arm group type: Experimental
  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 group label: FibroST-Spain
  arm group type: Active Comparator
  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 group label: Treatment as Usual (TAU)
  arm group type: Active Comparator
  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: Self-guided digital Acceptance and Commitment Therapy
  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.
  arm group label: STANZA-Spain
  intervention type: Device
  intervention name: FM symptom tracking app (FM-ST)
  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.
  arm group label: FibroST-Spain
  intervention type: Behavioral
  intervention name: Treatment as Usual (TAU)
  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)
  arm group label: FibroST-Spain
  arm group label: STANZA-Spain
  arm group label: Treatment as Usual (TAU)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Juan V Luciano, PhD
  role: Principal Investigator
  affiliation: Universitat Autònoma de Barcelona (UAB) & FSJD
  last name: Jaime Navarrete, PhD
  phone: +34936406350
  phone ext: 2543
  email: jaime.navarrete@sjd.es
  last name: Mayte Serrat, PhD
  phone: +34934863000
  phone ext: 3361
  email: mayte.serrat@vallhebron.cat
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  country: Spain
  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.
  PMID: 37382794
  responsible party type: Sponsor
  mesh term: Fibromyalgia
  mesh term: Myofascial Pain Syndromes
  sharing ipd: No