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/NCT05962138</url>
    </required_header>
    <id_info>
      <org_study_id>252762</org_study_id>
      <nct_id>NCT05962138</nct_id>
    </id_info>
    <brief_title>A Study of Digital Cognitive Behavioural Therapy for Insomnia in Fibromyalgia</brief_title>
    <acronym>Pain-LESS</acronym>
    <official_title>Characterisation of Pain in Patients With Musculoskeletal Disease: a Prospective, Longitudinal, Observational Study With an Embedded Feasibility Window of Opportunity Sleep Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Oxford</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Big Health Ltd.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Oxford</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>
        The goal of this clinical trial is to investigate the potential benefits of a digital&#xD;
        Cognitive Behavioural Therapy for Insomnia (dCBT-I) platform, Sleepio, in individuals&#xD;
        suffering from fibromyalgia, a condition commonly associated with cognitive issues and sleep&#xD;
        disorders.&#xD;
  &#xD;
        The main questions this study aims to answer are:&#xD;
  &#xD;
          -  Does the application of Sleepio improve quality of life in individuals with&#xD;
             fibromyalgia?&#xD;
  &#xD;
          -  Does the use of Sleepio improve cognitive function in individuals with fibromyalgia?&#xD;
  &#xD;
          -  Does the use of Sleepio enhance sleep quality in these same individuals?&#xD;
  &#xD;
          -  Does the use of Sleepio improve motor function in this group?&#xD;
  &#xD;
        Participants will be randomly assigned to either use the Sleepio platform or standardised&#xD;
        health advice, including sleep hygiene material. Those assigned to Sleepio will undergo a&#xD;
        series of six 20-minute sessions over 10 weeks with a virtual therapist focusing on cognitive&#xD;
        and behavioural strategies for improving sleep.&#xD;
  &#xD;
        Participants' quality of life, cognitive function, sleep quality, and pain levels will be&#xD;
        monitored and evaluated using online assessment tools. Additionally, a subset of participants&#xD;
        will undergo further testing via sleep actigraphy and/or neuroimaging with MRI scans.&#xD;
  &#xD;
        Researchers will compare the two groups to determine if the use of Sleepio has a positive&#xD;
        effect on quality of life, cognitive function, and sleep quality.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Fibromyalgia patients commonly experience cognitive issues such as concentration and memory&#xD;
        difficulties and sleep disorders. Despite the prevalence of these symptoms, no established&#xD;
        treatments currently exist. Traditional in-person Cognitive Behavioural Therapy (CBT), which&#xD;
        focuses on modifying unhelpful thoughts and behaviours, is both expensive and challenging to&#xD;
        deliver on a broad scale. New digital forms of CBT, specifically for insomnia (CBT-I), have&#xD;
        shown promise in improving cognitive symptoms and sleep quality, but their effect on&#xD;
        fibromyalgia patients is yet to be explored.&#xD;
  &#xD;
        The study will investigate the efficacy of 'Sleepio', an established digital CBT-I (dCBT-I)&#xD;
        tool. Sleepio has shown effectiveness in treating insomnia and its cognitive symptoms,&#xD;
        offering a promising approach to address similar issues in fibromyalgia. Sleepio's approach&#xD;
        involves six 20-minute sessions over 10 weeks with a virtual therapist who employs key&#xD;
        cognitive and behavioural strategies to enhance sleep quality.&#xD;
  &#xD;
        Participants in this study will be randomised in a 1:1 ratio to either treatment with Sleepio&#xD;
        treatment or standard care with standard sleep hygiene advice. The primary outcome is quality&#xD;
        of life measured on the Revised Fibromyalgia Impact Questionnaire (FIQR), 12 weeks following&#xD;
        randomisation. Secondary outcomes include subjective cognition (British Columbia Cognitive&#xD;
        Complaints Inventory, BC-CCI), objective cognitive function (tests of reaction time, working&#xD;
        memory, processing speed), quantitative cognitive avoidance testing (QCAT), sleep quality&#xD;
        (actigraphy, insomnia severity index (ISI), Pittsburgh Sleep Quality Index (PSQI), pain&#xD;
        (NRS), fear of movement (Tampa Scale of Kinesiophobia) and quantitative movement assessment.&#xD;
        Assessments will be carried out using online tools.&#xD;
  &#xD;
        Additionally, a subset of participants will undergo sleep actigraphy and/or neuroimaging&#xD;
        using MRI scans for a more detailed analysis.&#xD;
  &#xD;
        Primary Objectives:&#xD;
  &#xD;
        - Assess the impact of Sleepio (dCBT-I) on quality of life (FIQR) in fibromyalgia patients.&#xD;
  &#xD;
        Secondary Objectives:&#xD;
  &#xD;
          -  Assess the impact of Sleepio (dCBT-I) on subjective (BC-CCI) and objective cognitive&#xD;
             function in fibromyalgia patients.&#xD;
  &#xD;
          -  Investigate the effect of Sleepio on sleep quality (ISI &amp; PSQI) in fibromyalgia&#xD;
             patients.&#xD;
  &#xD;
          -  Investigate cost-effectiveness of Sleepio (dCBT-I)&#xD;
  &#xD;
          -  Does Sleepio improve subjective and objective measures of motor function in&#xD;
             fibromyalgia?&#xD;
  &#xD;
        As part of the study, participants will also be invited to join a research database for&#xD;
        potential inclusion in future studies conducted by the research group.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2024</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>
      <intervention_model_description>A randomised controlled trial with two parallel study arms: (1) digital cognitive behavioural therapy for insomnia (experimental condition), and (2) treatment as usual (control condition). Randomisation will be using a 1:1 ratio (experimental:control), within minimisation of between group differences in sex, and inclusion status in imaging sub-study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
      <masking_description>Baseline assessment, randomisation and facilitation of the intervention will be performed by members of the research team who will be blinded to group allocation. The investigators analysing the data will be blinded to group allocations.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Revised Fibromyalgia Impact Questionnaire (FIQR) from baseline</measure>
      <time_frame>12 weeks</time_frame>
      <description>The revised Fibromyalgia Impact Questionnaire (FIQR), range 0-100, is a self-reported measure designed to assess the overall impact of fibromyalgia on patients' lives, capturing domains such as physical impairment, overall well-being, and the intensity of symptoms like pain, fatigue, stiffness, sleep disturbances, and cognitive problems. Higher scores indicate more severe symptoms.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Revised Fibromyalgia Impact Questionnaire (FIQR) from baseline</measure>
      <time_frame>24 weeks</time_frame>
      <description>The revised Fibromyalgia Impact Questionnaire (FIQR), range 0-100, is a self-reported measure designed to assess the overall impact of fibromyalgia on patients' lives, capturing domains such as physical impairment, overall well-being, and the intensity of symptoms like pain, fatigue, stiffness, sleep disturbances, and cognitive problems. Higher scores indicate more severe symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep quality</measure>
      <time_frame>12 weeks</time_frame>
      <description>Changes in sleep pattern on actigraphy between treatment groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Revised Fibromyalgia Impact Questionnaire (FIQR) from baseline</measure>
      <time_frame>52 weeks</time_frame>
      <description>The revised Fibromyalgia Impact Questionnaire (FIQR), range 0-100, is a self-reported measure designed to assess the overall impact of fibromyalgia on patients' lives, capturing domains such as physical impairment, overall well-being, and the intensity of symptoms like pain, fatigue, stiffness, sleep disturbances, and cognitive problems. Higher scores indicate more severe symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline</measure>
      <time_frame>12 weeks</time_frame>
      <description>The British Columbia Cognitive Complaints Inventory (BC-CCI), range 0-18, is a rapid screening tool that assesses perceived cognitive difficulties. Higher scores indicate more severe symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline</measure>
      <time_frame>24 weeks</time_frame>
      <description>The British Columbia Cognitive Complaints Inventory (BC-CCI), range 0-18, is a rapid screening tool that assesses perceived cognitive difficulties. Higher scores indicate more severe symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline</measure>
      <time_frame>52 weeks</time_frame>
      <description>The British Columbia Cognitive Complaints Inventory (BC-CCI), range 0-18, is a rapid screening tool that assesses perceived cognitive difficulties. Higher scores indicate more severe symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Tampa Scale of Kinesiophobia (TSK) from baseline</measure>
      <time_frame>12 weeks</time_frame>
      <description>The Tampa Scale of Kinesiophobia (TSK), range 17-68, is a patient-reported outcome measure designed to quantify kinesiophobia or fear of movement. Higher scores indicate greater fear of movement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Tampa Scale of Kinesiophobia (TSK) from baseline</measure>
      <time_frame>24 weeks</time_frame>
      <description>The Tampa Scale of Kinesiophobia (TSK), range 17-68, is a patient-reported outcome measure designed to quantify kinesiophobia or fear of movement. Higher scores indicate greater fear of movement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Tampa Scale of Kinesiophobia (TSK) from baseline</measure>
      <time_frame>52 weeks</time_frame>
      <description>The Tampa Scale of Kinesiophobia (TSK), range 17-68, is a patient-reported outcome measure designed to quantify kinesiophobia or fear of movement. Higher scores indicate greater fear of movement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cost-effectiveness of dCBT-I</measure>
      <time_frame>12 weeks</time_frame>
      <description>Health-related quality of life measured with EQ-5D-3L (European Quality of Life 5 Dimensions 3 Level Version) at baseline, 3- and 6-months. Healthcare resource use data collected at 3- and 6-months. This will be evaluated using cost-effectiveness analysis looking at cost per quality adjusted life year (QALY) with the treatment. QALYs will be estimated using EQ-5D-3L, with higher values indicating better health outcomes. The EQ-5D-3L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease. One quality-adjusted life year (QALY) is equal to 1 year of life in perfect health. QALYs will be calculated by estimating the years of life remaining for a patient following a particular treatment or intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale) from the EQ-5D-3L. Healthcare resource use will be evaluated in the local currency (£).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cost-effectiveness of dCBT-I</measure>
      <time_frame>24 weeks</time_frame>
      <description>Health-related quality of life measured with EQ-5D-3L (European Quality of Life 5 Dimensions 3 Level Version) at baseline, 3- and 6-months. Healthcare resource use data collected at 3- and 6-months. This will be evaluated using cost-effectiveness analysis looking at cost per quality adjusted life year (QALY) with the treatment. QALYs will be estimated using EQ-5D-3L, with higher values indicating better health outcomes. The EQ-5D-3L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease. One quality-adjusted life year (QALY) is equal to 1 year of life in perfect health. QALYs will be calculated by estimating the years of life remaining for a patient following a particular treatment or intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale) from the EQ-5D-3L. Healthcare resource use will be evaluated in the local currency (£).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in brain structure</measure>
      <time_frame>12 weeks</time_frame>
      <description>Change in brain grey matter volume on structural MRI</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in brain functional connectivity</measure>
      <time_frame>12 weeks</time_frame>
      <description>Changes in brain resting state functional connectivity on resting-state functional MRI</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in neurotransmitter concentration in the insular</measure>
      <time_frame>12 weeks</time_frame>
      <description>Changes in neurotransmitter concentration in the insular on magnetic resonance spectroscopy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in brain function</measure>
      <time_frame>12 weeks</time_frame>
      <description>Changes in brain resting state activity on arterial spin labelling (ASL) on brain MRI</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Fibromyalgia</condition>
    <arm_group>
      <arm_group_label>Sleepio (dCBT-I)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online.&#xD;
  Participants will also receive a booklet with general advice for patients with fibromyalgia, including sleep hygiene.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment as usual</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants will receive a booklet published by Versus Arthritis designed for patients with fibromyalgia with general advice, including sleep hygiene.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Digital Cognitive Behavioural Therapy for Insomnia</intervention_name>
      <description>6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online. In addition participants will receive a booklet published by Versus Arthritis designed for patients with fibromyalgia with general advice, including sleep hygiene.</description>
      <arm_group_label>Sleepio (dCBT-I)</arm_group_label>
      <other_name>Sleepio</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Clinical diagnosis of fibromyalgia&#xD;
  &#xD;
            -  Concomitant insomnia, frequent waking in the night or early morning waking&#xD;
  &#xD;
            -  Self-reported difficulties with concentration or memory&#xD;
  &#xD;
            -  Reliable internet access&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with a poor understanding of English.&#xD;
  &#xD;
            -  Patients with known neurological or psychiatric conditions (other than depression or&#xD;
               anxiety) likely to independently affect the results of pain assessment, for example&#xD;
               peripheral diabetic neuropathy in the opinion of the research team&#xD;
  &#xD;
            -  Major neuropsychiatric disorder (bipolar disorder, schizophrenia or psychotic spectrum&#xD;
               disorders)&#xD;
  &#xD;
            -  Epilepsy&#xD;
  &#xD;
            -  Cognitive impairment, dementia or neurodegenerative disorder&#xD;
  &#xD;
            -  Recent or planned surgery&#xD;
  &#xD;
            -  Current or planned night-time shift work&#xD;
  &#xD;
            -  Sleep disorders such as sleep apnoea, restless leg syndrome, circadian rhythm&#xD;
               disorder, or parasomnia&#xD;
  &#xD;
            -  Taking prescribed sleep medications on more than 2 nights in past 2 weeks&#xD;
  &#xD;
            -  Currently receiving other psychological therapy for insomnia&#xD;
  &#xD;
            -  Pregnant or lactating&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Anushka Soni, Dr</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Oxford</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Anushka Soni, Dr</last_name>
      <phone>+441865 234829</phone>
      <email>anushka.soni@ndorms.ox.ac.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Eoin Kelleher, Dr</last_name>
      <email>fibromyalgia@ndcn.ox.ac.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Oxford</name>
        <address>
          <city>Oxford</city>
          <zip>OX3 9DU</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Eoin Kelleher, Dr</last_name>
        <email>fibromyalgia@ndcn.ox.ac.uk</email>
      </contact>
      <contact_backup>
        <last_name>Amanda Wall</last_name>
        <email>amanda.wall@ndcn.ox.ac.uk</email>
      </contact_backup>
      <investigator>
        <last_name>Amanda Wall</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Eoin Kelleher, Dr</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Anushka Soni, Dr</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Tamsin Hughes</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Vishvarani Wanigasekera, Dr</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Irene Tracey, Prof</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ben Seymour, Prof</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 26, 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>
    <keyword>sleep</keyword>
    <keyword>digital</keyword>
    <keyword>cognitive behavioural therapy for insomnia</keyword>
    <keyword>fibromyalgia</keyword>
    <keyword>pain</keyword>
    <keyword>cognition</keyword>
    <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>Yes</sharing_ipd>
      <ipd_description>De-identified data are available upon reasonable request</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Following publication of results</ipd_time_frame>
      <ipd_access_criteria>Available upon reasonable request</ipd_access_criteria>
    </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/NCT05962138
  org study id: 252762
  nct id: NCT05962138
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to investigate the potential benefits of a digital
        Cognitive Behavioural Therapy for Insomnia (dCBT-I) platform, Sleepio, in individuals
        suffering from fibromyalgia, a condition commonly associated with cognitive issues and sleep
        disorders.
  
        The main questions this study aims to answer are:
  
          -  Does the application of Sleepio improve quality of life in individuals with
             fibromyalgia?
  
          -  Does the use of Sleepio improve cognitive function in individuals with fibromyalgia?
  
          -  Does the use of Sleepio enhance sleep quality in these same individuals?
  
          -  Does the use of Sleepio improve motor function in this group?
  
        Participants will be randomly assigned to either use the Sleepio platform or standardised
        health advice, including sleep hygiene material. Those assigned to Sleepio will undergo a
        series of six 20-minute sessions over 10 weeks with a virtual therapist focusing on cognitive
        and behavioural strategies for improving sleep.
  
        Participants' quality of life, cognitive function, sleep quality, and pain levels will be
        monitored and evaluated using online assessment tools. Additionally, a subset of participants
        will undergo further testing via sleep actigraphy and/or neuroimaging with MRI scans.
  
        Researchers will compare the two groups to determine if the use of Sleepio has a positive
        effect on quality of life, cognitive function, and sleep quality.
  Fibromyalgia patients commonly experience cognitive issues such as concentration and memory
        difficulties and sleep disorders. Despite the prevalence of these symptoms, no established
        treatments currently exist. Traditional in-person Cognitive Behavioural Therapy (CBT), which
        focuses on modifying unhelpful thoughts and behaviours, is both expensive and challenging to
        deliver on a broad scale. New digital forms of CBT, specifically for insomnia (CBT-I), have
        shown promise in improving cognitive symptoms and sleep quality, but their effect on
        fibromyalgia patients is yet to be explored.
  
        The study will investigate the efficacy of 'Sleepio', an established digital CBT-I (dCBT-I)
        tool. Sleepio has shown effectiveness in treating insomnia and its cognitive symptoms,
        offering a promising approach to address similar issues in fibromyalgia. Sleepio's approach
        involves six 20-minute sessions over 10 weeks with a virtual therapist who employs key
        cognitive and behavioural strategies to enhance sleep quality.
  
        Participants in this study will be randomised in a 1:1 ratio to either treatment with Sleepio
        treatment or standard care with standard sleep hygiene advice. The primary outcome is quality
        of life measured on the Revised Fibromyalgia Impact Questionnaire (FIQR), 12 weeks following
        randomisation. Secondary outcomes include subjective cognition (British Columbia Cognitive
        Complaints Inventory, BC-CCI), objective cognitive function (tests of reaction time, working
        memory, processing speed), quantitative cognitive avoidance testing (QCAT), sleep quality
        (actigraphy, insomnia severity index (ISI), Pittsburgh Sleep Quality Index (PSQI), pain
        (NRS), fear of movement (Tampa Scale of Kinesiophobia) and quantitative movement assessment.
        Assessments will be carried out using online tools.
  
        Additionally, a subset of participants will undergo sleep actigraphy and/or neuroimaging
        using MRI scans for a more detailed analysis.
  
        Primary Objectives:
  
        - Assess the impact of Sleepio (dCBT-I) on quality of life (FIQR) in fibromyalgia patients.
  
        Secondary Objectives:
  
          -  Assess the impact of Sleepio (dCBT-I) on subjective (BC-CCI) and objective cognitive
             function in fibromyalgia patients.
  
          -  Investigate the effect of Sleepio on sleep quality (ISI & PSQI) in fibromyalgia
             patients.
  
          -  Investigate cost-effectiveness of Sleepio (dCBT-I)
  
          -  Does Sleepio improve subjective and objective measures of motor function in
             fibromyalgia?
  
        As part of the study, participants will also be invited to join a research database for
        potential inclusion in future studies conducted by the research group.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A randomised controlled trial with two parallel study arms: (1) digital cognitive behavioural therapy for insomnia (experimental condition), and (2) treatment as usual (control condition). Randomisation will be using a 1:1 ratio (experimental:control), within minimisation of between group differences in sex, and inclusion status in imaging sub-study
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  masking description: Baseline assessment, randomisation and facilitation of the intervention will be performed by members of the research team who will be blinded to group allocation. The investigators analysing the data will be blinded to group allocations.
  measure: Change in Revised Fibromyalgia Impact Questionnaire (FIQR) from baseline
  time frame: 12 weeks
  description: The revised Fibromyalgia Impact Questionnaire (FIQR), range 0-100, is a self-reported measure designed to assess the overall impact of fibromyalgia on patients' lives, capturing domains such as physical impairment, overall well-being, and the intensity of symptoms like pain, fatigue, stiffness, sleep disturbances, and cognitive problems. Higher scores indicate more severe symptoms.
  measure: Change in Revised Fibromyalgia Impact Questionnaire (FIQR) from baseline
  time frame: 24 weeks
  description: The revised Fibromyalgia Impact Questionnaire (FIQR), range 0-100, is a self-reported measure designed to assess the overall impact of fibromyalgia on patients' lives, capturing domains such as physical impairment, overall well-being, and the intensity of symptoms like pain, fatigue, stiffness, sleep disturbances, and cognitive problems. Higher scores indicate more severe symptoms.
  measure: Sleep quality
  time frame: 12 weeks
  description: Changes in sleep pattern on actigraphy between treatment groups
  measure: Change in Revised Fibromyalgia Impact Questionnaire (FIQR) from baseline
  time frame: 52 weeks
  description: The revised Fibromyalgia Impact Questionnaire (FIQR), range 0-100, is a self-reported measure designed to assess the overall impact of fibromyalgia on patients' lives, capturing domains such as physical impairment, overall well-being, and the intensity of symptoms like pain, fatigue, stiffness, sleep disturbances, and cognitive problems. Higher scores indicate more severe symptoms.
  measure: Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline
  time frame: 12 weeks
  description: The British Columbia Cognitive Complaints Inventory (BC-CCI), range 0-18, is a rapid screening tool that assesses perceived cognitive difficulties. Higher scores indicate more severe symptoms.
  measure: Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline
  time frame: 24 weeks
  description: The British Columbia Cognitive Complaints Inventory (BC-CCI), range 0-18, is a rapid screening tool that assesses perceived cognitive difficulties. Higher scores indicate more severe symptoms.
  measure: Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline
  time frame: 52 weeks
  description: The British Columbia Cognitive Complaints Inventory (BC-CCI), range 0-18, is a rapid screening tool that assesses perceived cognitive difficulties. Higher scores indicate more severe symptoms.
  measure: Change in Tampa Scale of Kinesiophobia (TSK) from baseline
  time frame: 12 weeks
  description: The Tampa Scale of Kinesiophobia (TSK), range 17-68, is a patient-reported outcome measure designed to quantify kinesiophobia or fear of movement. Higher scores indicate greater fear of movement.
  measure: Change in Tampa Scale of Kinesiophobia (TSK) from baseline
  time frame: 24 weeks
  description: The Tampa Scale of Kinesiophobia (TSK), range 17-68, is a patient-reported outcome measure designed to quantify kinesiophobia or fear of movement. Higher scores indicate greater fear of movement.
  measure: Change in Tampa Scale of Kinesiophobia (TSK) from baseline
  time frame: 52 weeks
  description: The Tampa Scale of Kinesiophobia (TSK), range 17-68, is a patient-reported outcome measure designed to quantify kinesiophobia or fear of movement. Higher scores indicate greater fear of movement.
  measure: Cost-effectiveness of dCBT-I
  time frame: 12 weeks
  description: Health-related quality of life measured with EQ-5D-3L (European Quality of Life 5 Dimensions 3 Level Version) at baseline, 3- and 6-months. Healthcare resource use data collected at 3- and 6-months. This will be evaluated using cost-effectiveness analysis looking at cost per quality adjusted life year (QALY) with the treatment. QALYs will be estimated using EQ-5D-3L, with higher values indicating better health outcomes. The EQ-5D-3L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease. One quality-adjusted life year (QALY) is equal to 1 year of life in perfect health. QALYs will be calculated by estimating the years of life remaining for a patient following a particular treatment or intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale) from the EQ-5D-3L. Healthcare resource use will be evaluated in the local currency (£).
  measure: Cost-effectiveness of dCBT-I
  time frame: 24 weeks
  description: Health-related quality of life measured with EQ-5D-3L (European Quality of Life 5 Dimensions 3 Level Version) at baseline, 3- and 6-months. Healthcare resource use data collected at 3- and 6-months. This will be evaluated using cost-effectiveness analysis looking at cost per quality adjusted life year (QALY) with the treatment. QALYs will be estimated using EQ-5D-3L, with higher values indicating better health outcomes. The EQ-5D-3L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease. One quality-adjusted life year (QALY) is equal to 1 year of life in perfect health. QALYs will be calculated by estimating the years of life remaining for a patient following a particular treatment or intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale) from the EQ-5D-3L. Healthcare resource use will be evaluated in the local currency (£).
  measure: Changes in brain structure
  time frame: 12 weeks
  description: Change in brain grey matter volume on structural MRI
  measure: Changes in brain functional connectivity
  time frame: 12 weeks
  description: Changes in brain resting state functional connectivity on resting-state functional MRI
  measure: Changes in neurotransmitter concentration in the insular
  time frame: 12 weeks
  description: Changes in neurotransmitter concentration in the insular on magnetic resonance spectroscopy
  measure: Changes in brain function
  time frame: 12 weeks
  description: Changes in brain resting state activity on arterial spin labelling (ASL) on brain MRI
  arm group label: Sleepio (dCBT-I)
  arm group type: Experimental
  description: 6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online.
  Participants will also receive a booklet with general advice for patients with fibromyalgia, including sleep hygiene.
  arm group label: Treatment as usual
  arm group type: No Intervention
  description: Participants will receive a booklet published by Versus Arthritis designed for patients with fibromyalgia with general advice, including sleep hygiene.
  intervention type: Behavioral
  intervention name: Digital Cognitive Behavioural Therapy for Insomnia
  description: 6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online. In addition participants will receive a booklet published by Versus Arthritis designed for patients with fibromyalgia with general advice, including sleep hygiene.
  arm group label: Sleepio (dCBT-I)
  other name: Sleepio
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Anushka Soni, Dr
  role: Principal Investigator
  affiliation: University of Oxford
  last name: Anushka Soni, Dr
  phone: +441865 234829
  email: anushka.soni@ndorms.ox.ac.uk
  last name: Eoin Kelleher, Dr
  email: fibromyalgia@ndcn.ox.ac.uk
  facility: 
  status: Recruiting
  contact: 
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  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Fibromyalgia
  mesh term: Myofascial Pain Syndromes
  sharing ipd: Yes
  ipd description: De-identified data are available upon reasonable request
  ipd info type: Study Protocol
  ipd time frame: Following publication of results
  ipd access criteria: Available upon reasonable request