<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/NCT02232100</url>
  </required_header>
  <id_info>
    <org_study_id>ABMT2014</org_study_id>
    <nct_id>NCT02232100</nct_id>
  </id_info>
  <brief_title>Attentional Bias Modification Training for People With Chronic Musculoskeletal Pain</brief_title>
  <acronym>I-ABMT</acronym>
  <official_title>Internet-Delivered Attentional Bias Modification Training in People With Chronic Musculoskeletal Pain: A Double-Blind Randomised Control Trial and a Qualitative Investigation of Participants' Experience.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southampton</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Southampton</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>
      Chronic musculoskeletal pain is a complex medical condition associated with significant&#xD;
      distress, disability, and reduction in quality of life. Research has shown that patients with&#xD;
      chronic musculoskeletal pain demonstrate attentional biases towards pain-related information.&#xD;
&#xD;
      The purpose of this study is to determine whether internet-delivered attentional bias&#xD;
      modification, which aims to implicitly train attention away from pain-related information,&#xD;
      has beneficial effects upon pain and pain-related distress in patients with chronic&#xD;
      musculoskeletal pain.&#xD;
&#xD;
      Participants will be randomised to either an attentional training condition, or to a&#xD;
      no-training placebo condition. The primary outcome measures are pain intensity and pain&#xD;
      interference, and secondary outcome measures include anxiety, depression, pain-related fear&#xD;
      and sleep problems.&#xD;
&#xD;
      Data will be analysed and reported separately for participants aged 16 - 24 and 25 - 60. It&#xD;
      is hypothesized that participants receiving internet-delivered attentional bias modification&#xD;
      will show significantly greater reductions in pain and pain-related distress compared to&#xD;
      participants receiving placebo training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic musculoskeletal pain is a complex medical condition. Patients often experience&#xD;
      increased levels of pain-related distress, including anxiety, depression and disability,&#xD;
      impaired sleep, poor well-being and diminished quality of life. Over the past decade,&#xD;
      numerous studies have provided evidence for the existence of attentional bias towards&#xD;
      pain-related information in chronic pain patients. A critical question remaining unanswered&#xD;
      is whether pain-related bias is simply an epiphenomenon of chronic pain, or whether it has a&#xD;
      causal role in the maintenance of pain. Recently, there has been growing interest in the&#xD;
      potential benefits of attentional retraining in individuals with various emotional disorders,&#xD;
      with focus upon attentional bias modification (ABM).&#xD;
&#xD;
      ABM is a theory-driven intervention which uses computer-based paradigms, typically the&#xD;
      visual-probe task, to implicitly manipulate attention away from sources of threat relevant to&#xD;
      the individual's fears or concerns. To date, three published studies using ABM with chronic&#xD;
      pain patients exist, the combined results of which support the therapeutic benefits of ABM on&#xD;
      pain, pain-related distress and disability. Considering these encouraging results, it is&#xD;
      important to expand this field of research and explore ABM in chronic pain in greater depth.&#xD;
      In particular, all former studies assessed the clinical effectiveness of ABM in laboratory&#xD;
      environments. The purpose of this double-blind RCT study is to determine whether&#xD;
      internet-delivered ABM training (I-ABMT) has therapeutic benefits for patients with chronic&#xD;
      musculoskeletal pain on pain and pain-related distress, thereby assessing training effects in&#xD;
      real-world settings.&#xD;
&#xD;
      The visual-probe task will be used for assessment and modification of pain-related&#xD;
      attentional biases. This is a computerised paradigm which records participant response times&#xD;
      to a series of visual stimuli. Following an initial fixation point, each trial presents a&#xD;
      stimulus pair in distinct locations (e.g. left and right of the initial fixation point), for&#xD;
      a specified length of time (i.e., 500 or 1250ms). Stimuli may consist of words or images,&#xD;
      with experimental trials featuring one pain-related stimulus and one neutral stimulus.&#xD;
      Following this, both stimuli are removed, with a visual probe replacing one stimulus.&#xD;
      Participants indicate the location of this probe as quickly and accurately as possible via&#xD;
      manual response. Response times are faster to probes appearing in an attended region of the&#xD;
      screen than an unattended region, providing a measure of attentional allocation. Averaged&#xD;
      response times are calculated, which are converted into an index of attentional bias. In the&#xD;
      standard and control (i.e., placebo) versions of the visual probe task, the probe replaces&#xD;
      pain-related and neutral stimuli an equal number of times, while in the I-ABMT version, the&#xD;
      probe always replaces neutral stimuli thus training attention away from pain-related stimuli.&#xD;
&#xD;
      Dose effects will be explored in this study, with participants randomised to one of four&#xD;
      conditions: (i) 10-session Attentional Modification Group , (ii) 10-session Attentional&#xD;
      Control Group, (iii) 18-session Attentional Modification Group, and (iv) 18-session&#xD;
      Attentional Control Group. The primary outcome measures are pain intensity and pain&#xD;
      interference, and secondary outcome measures include anxiety, depression, pain-related fear&#xD;
      and sleeping impairment, including engagement to and satisfaction with the online&#xD;
      visual-probe training task. It is hypothesized that participants receiving ABM training will&#xD;
      show significantly greater reductions in pain and pain-related distress compared to&#xD;
      participants receiving placebo training. Dose effects will be investigated in an exploratory&#xD;
      manner, and data will be analysed and reported separately for participants aged 16 - 24 and&#xD;
      25 - 60.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">November 1, 2021</start_date>
  <completion_date type="Anticipated">November 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2023</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain intensity - change from baseline on an 11-point scale (0 no pain, 10 pain as bad as you can imagine) to endline (4 or 8 weeks)</measure>
    <time_frame>Baseline, following intervention (4 or 8 weeks)</time_frame>
    <description>Likert scale from the Brief Pain Inventory-Short Form (BPS-SF), a commonly used measure of pain intensity and pain interference.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain interference- change from baseline on an 11-point scale (0 does not interfere, 10 completely interferes) to endline (4 or 8 weeks)</measure>
    <time_frame>Baseline, following intervention (4 or 8 weeks)</time_frame>
    <description>Likert scale from the Brief Pain Inventory-Short Form (BPS-SF), a commonly used measure of pain intensity and pain interference.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain intensity - change from baseline on an 11-point scale (0 no pain, 10 pain as bad as you can imagine) to 6-month follow-up</measure>
    <time_frame>Baseline, 6-month follow-up</time_frame>
    <description>Likert scale from the Brief Pain Inventory-Short Form (BPS-SF), a commonly used measure of pain intensity and pain interference.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain interference- change from baseline on an 11-point scale (0 does not interfere, 10 completely interferes) to 6-month follow-up</measure>
    <time_frame>Baseline, 6-month follow-up</time_frame>
    <description>Likert scale from the Brief Pain Inventory-Short Form (BPS-SF), a commonly used measure of pain intensity and pain interference.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety - change from baseline to endline (4 or 8 weeks)</measure>
    <time_frame>Baseline, following intervention (4 or 8 weeks)</time_frame>
    <description>State and Trait Anxiety Subscales from the State-Trait Anxiety Inventory (STAI), a 40-item measure of state and trait anxiety (20 items each). Each item is measured on a four point scale, with possible scores for both state and trait levels ranging between 20 and 80. State and trait subscales are not combined. Higher scores on each subscale represent more intense or more frequent feelings of anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression - change from baseline to endline (4 or 8 weeks)</measure>
    <time_frame>Baseline, following intervention (4 or 8 weeks)</time_frame>
    <description>Depression Subscale from Hospital Anxiety and Depression Scale, which is comprised of 7 items each measured on a four point scale. Possible scores for the depression subscale range between 0 and 21, with higher scores indicating higher levels of anxiety and depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain-related fear - change from baseline to endline (4 or 8 weeks)</measure>
    <time_frame>Baseline, following intervention (4 or 8 weeks)</time_frame>
    <description>Fear of Pain questionnaire III. On a 5-point scale, respondents are asked to rate how fearful they are of pain associated with specific situations and events (e.g., being in an automobile accident). Possible scores range between 30 and 150, with higher scores representing a more intense fear of pain. In addition to a total score, the measure also provides subscales of minor, severe, and medical pain-related fear.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleeping impairment - change from baseline to endline (4 or 8 weeks)</measure>
    <time_frame>Baseline, following intervention (4 or 8 weeks)</time_frame>
    <description>Medical Outcome Study Sleep Scale, a twelve-item questionnaire developed for patients with chronic illness, measuring six dimensions of sleep over the past four weeks; sleep initiation (time to fall asleep - five responses), quantity (the participant writes hours per night sleeping), maintenance, respiratory problems, perceived adequacy, and somnolence rated on a 6-point scale. A sleep problems index which summarises information from nine items is also be scored. Responses are recoded on a 0 - 100 scale, with higher scores indicating more of the concept being measured (e.g., greater difficulties falling asleep).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety - change from baseline to 6-month follow-up</measure>
    <time_frame>Baseline, 6-month follow-up</time_frame>
    <description>State and Trait Anxiety Subscales from State-Trait Anxiety Inventory(STAI), a 40-item measure of state and trait anxiety (20 items each). Each item is measured on a four point scale, with possible scores for both state and trait levels ranging between 20 and 80. State and trait subscales are not combined. Higher scores on each subscale represent more intense or more frequent feelings of anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression - change from baseline to 6-month follow-up</measure>
    <time_frame>Baseline, 6-month follow-up</time_frame>
    <description>Depression Subscale from Hospital Anxiety and Depression Scale, which is comprised of 7 items each measured on a four point scale. Possible scores for the depression subscale range between 0 and 21, with higher scores indicating higher levels of anxiety and depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain-related fear - change from baseline to 6-month follow-up</measure>
    <time_frame>Baseline, 6-month follow-up</time_frame>
    <description>Fear of Pain questionnaire III. On a 5-point scale, respondents are asked to rate how fearful they are of pain associated with specific situations and events (e.g., being in an automobile accident). Possible scores range between 30 and 150, with higher scores representing a more intense fear of pain. In addition to a total score, the measure also provides subscales of minor, severe, and medical pain-related fear.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleeping impairment - change from baseline to 6-month follow-up</measure>
    <time_frame>Baseline, 6-month follow-up</time_frame>
    <description>Medical Outcome Study Sleep Scale, a twelve-item questionnaire developed for patients with chronic illness, measuring six dimensions of sleep over the past four weeks; sleep initiation (time to fall asleep - five responses), quantity (the participant writes hours per night sleeping), maintenance, respiratory problems, perceived adequacy, and somnolence rated on a 6-point scale. A sleep problems index which summarises information from nine items is also be scored. Responses are recoded on a 0 - 100 scale, with higher scores indicating more of the concept being measured (e.g., greater difficulties falling asleep).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Satisfaction with the online ABMT</measure>
    <time_frame>Following intervention (4 or 8 weeks)</time_frame>
    <description>Satisfaction with the online treatment questionnaire. Participants state how strongly they agree/disagree with each of the following items: (a) the use of a computer to access treatment, (b) level of easiness of the online intervention, (c) duration of the potential effects of the treatment, and (d) potential recommendation of online interventions to others. Responses are provided on a 5-point scale ranging from &quot;Agree very strongly&quot; to &quot;Disagree very strongly&quot;. An additional question asks participants how helpful they have found the online intervention, with responses provided on a 4-point scale ranging from &quot;Very helpful&quot; to &quot;Not at all helpful&quot;. Two open questions are also included that require participants to state the aspects of the intervention they most liked and disliked.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>10AMG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Attentional bias modification group - 10 training sessions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>10ACG</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Attentional control group - 10 placebo sessions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>18AMG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Attentional bias modification group - 18 training sessions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>18ACG</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Attentional control group - 18 placebo sessions</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Attentional bias modification training (AMG)</intervention_name>
    <description>Attentional bias modification, administered via an internet-delivered visual-probe task that trains attention away from pain-related information</description>
    <arm_group_label>10AMG</arm_group_label>
    <arm_group_label>18AMG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Attentional bias placebo (ACG)</intervention_name>
    <description>Attentional bias placebo, administered via an internet-delivered visual-probe task that does not train attention either away or towards pain-related information</description>
    <arm_group_label>10ACG</arm_group_label>
    <arm_group_label>18ACG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. aged between 16 to 60 years old&#xD;
&#xD;
          2. experiencing any type of CMSK (i.e., any condition that involves pain lasting for more&#xD;
             than three months and arises from bones, muscles and/or joints)&#xD;
&#xD;
          3. able to sit at a personal computer for forty minutes&#xD;
&#xD;
          4. normal or corrected to normal vision&#xD;
&#xD;
          5. access to the internet at least twice a week&#xD;
&#xD;
          6. access to, and familiarity using, a Windows-based computer (g) successful completion&#xD;
             of primary school&#xD;
&#xD;
          7. living in the United Kingdom.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. experiencing malignant CMSK (i.e., pain caused due to a tumour)&#xD;
&#xD;
          2. a diagnosis of any psychiatric disorder, either currently or within the last 5 years&#xD;
&#xD;
          3. currently under psychiatric therapy.&#xD;
&#xD;
        No restrictions are placed on concomitant care and participants are not required to make&#xD;
        any changes to current treatments they may be receiving.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christina Liossi, DPsych</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southampton</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christina Liossi, DPsych</last_name>
    <phone>+44 23 8059 4645</phone>
    <email>c.liossi@soton.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Daniel E Schoth, PhD</last_name>
    <phone>+44 23 8059 4518</phone>
    <email>d.e.schoth@soton.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Southampton</name>
      <address>
        <city>Southampton</city>
        <state>Hampshire</state>
        <zip>SO17 1BJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <contact>
      <last_name>Christina Liossi, DPsych</last_name>
      <phone>+44 23 8059 4645</phone>
      <email>c.liossi@soton.ac.uk</email>
    </contact>
    <contact_backup>
      <last_name>Daniel E Schoth, PhD</last_name>
      <phone>+44 23 8059 4518</phone>
      <email>d.e.schoth@soton.ac.uk</email>
    </contact_backup>
    <investigator>
      <last_name>Christina Liossi, DPsych</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Daniel E Schoth, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>May 14, 2021</last_update_submitted>
  <last_update_submitted_qc>May 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Attentional bias modification training</keyword>
  <keyword>Chronic pain</keyword>
  <keyword>Visual-probe task</keyword>
  <keyword>Internet-delivered therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Pain</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02232100
org study id: ABMT2014
nct id: NCT02232100
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chronic musculoskeletal pain is a complex medical condition associated with significant
      distress, disability, and reduction in quality of life. Research has shown that patients with
      chronic musculoskeletal pain demonstrate attentional biases towards pain-related information.

      The purpose of this study is to determine whether internet-delivered attentional bias
      modification, which aims to implicitly train attention away from pain-related information,
      has beneficial effects upon pain and pain-related distress in patients with chronic
      musculoskeletal pain.

      Participants will be randomised to either an attentional training condition, or to a
      no-training placebo condition. The primary outcome measures are pain intensity and pain
      interference, and secondary outcome measures include anxiety, depression, pain-related fear
      and sleep problems.

      Data will be analysed and reported separately for participants aged 16 - 24 and 25 - 60. It
      is hypothesized that participants receiving internet-delivered attentional bias modification
      will show significantly greater reductions in pain and pain-related distress compared to
      participants receiving placebo training.
Chronic musculoskeletal pain is a complex medical condition. Patients often experience
      increased levels of pain-related distress, including anxiety, depression and disability,
      impaired sleep, poor well-being and diminished quality of life. Over the past decade,
      numerous studies have provided evidence for the existence of attentional bias towards
      pain-related information in chronic pain patients. A critical question remaining unanswered
      is whether pain-related bias is simply an epiphenomenon of chronic pain, or whether it has a
      causal role in the maintenance of pain. Recently, there has been growing interest in the
      potential benefits of attentional retraining in individuals with various emotional disorders,
      with focus upon attentional bias modification (ABM).

      ABM is a theory-driven intervention which uses computer-based paradigms, typically the
      visual-probe task, to implicitly manipulate attention away from sources of threat relevant to
      the individual's fears or concerns. To date, three published studies using ABM with chronic
      pain patients exist, the combined results of which support the therapeutic benefits of ABM on
      pain, pain-related distress and disability. Considering these encouraging results, it is
      important to expand this field of research and explore ABM in chronic pain in greater depth.
      In particular, all former studies assessed the clinical effectiveness of ABM in laboratory
      environments. The purpose of this double-blind RCT study is to determine whether
      internet-delivered ABM training (I-ABMT) has therapeutic benefits for patients with chronic
      musculoskeletal pain on pain and pain-related distress, thereby assessing training effects in
      real-world settings.

      The visual-probe task will be used for assessment and modification of pain-related
      attentional biases. This is a computerised paradigm which records participant response times
      to a series of visual stimuli. Following an initial fixation point, each trial presents a
      stimulus pair in distinct locations (e.g. left and right of the initial fixation point), for
      a specified length of time (i.e., 500 or 1250ms). Stimuli may consist of words or images,
      with experimental trials featuring one pain-related stimulus and one neutral stimulus.
      Following this, both stimuli are removed, with a visual probe replacing one stimulus.
      Participants indicate the location of this probe as quickly and accurately as possible via
      manual response. Response times are faster to probes appearing in an attended region of the
      screen than an unattended region, providing a measure of attentional allocation. Averaged
      response times are calculated, which are converted into an index of attentional bias. In the
      standard and control (i.e., placebo) versions of the visual probe task, the probe replaces
      pain-related and neutral stimuli an equal number of times, while in the I-ABMT version, the
      probe always replaces neutral stimuli thus training attention away from pain-related stimuli.

      Dose effects will be explored in this study, with participants randomised to one of four
      conditions: (i) 10-session Attentional Modification Group , (ii) 10-session Attentional
      Control Group, (iii) 18-session Attentional Modification Group, and (iv) 18-session
      Attentional Control Group. The primary outcome measures are pain intensity and pain
      interference, and secondary outcome measures include anxiety, depression, pain-related fear
      and sleeping impairment, including engagement to and satisfaction with the online
      visual-probe training task. It is hypothesized that participants receiving ABM training will
      show significantly greater reductions in pain and pain-related distress compared to
      participants receiving placebo training. Dose effects will be investigated in an exploratory
      manner, and data will be analysed and reported separately for participants aged 16 - 24 and
      25 - 60.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Pain intensity - change from baseline on an 11-point scale (0 no pain, 10 pain as bad as you can imagine) to endline (4 or 8 weeks)
time frame: Baseline, following intervention (4 or 8 weeks)
description: Likert scale from the Brief Pain Inventory-Short Form (BPS-SF), a commonly used measure of pain intensity and pain interference.
measure: Pain interference- change from baseline on an 11-point scale (0 does not interfere, 10 completely interferes) to endline (4 or 8 weeks)
time frame: Baseline, following intervention (4 or 8 weeks)
description: Likert scale from the Brief Pain Inventory-Short Form (BPS-SF), a commonly used measure of pain intensity and pain interference.
measure: Pain intensity - change from baseline on an 11-point scale (0 no pain, 10 pain as bad as you can imagine) to 6-month follow-up
time frame: Baseline, 6-month follow-up
description: Likert scale from the Brief Pain Inventory-Short Form (BPS-SF), a commonly used measure of pain intensity and pain interference.
measure: Pain interference- change from baseline on an 11-point scale (0 does not interfere, 10 completely interferes) to 6-month follow-up
time frame: Baseline, 6-month follow-up
description: Likert scale from the Brief Pain Inventory-Short Form (BPS-SF), a commonly used measure of pain intensity and pain interference.
measure: Anxiety - change from baseline to endline (4 or 8 weeks)
time frame: Baseline, following intervention (4 or 8 weeks)
description: State and Trait Anxiety Subscales from the State-Trait Anxiety Inventory (STAI), a 40-item measure of state and trait anxiety (20 items each). Each item is measured on a four point scale, with possible scores for both state and trait levels ranging between 20 and 80. State and trait subscales are not combined. Higher scores on each subscale represent more intense or more frequent feelings of anxiety.
measure: Depression - change from baseline to endline (4 or 8 weeks)
time frame: Baseline, following intervention (4 or 8 weeks)
description: Depression Subscale from Hospital Anxiety and Depression Scale, which is comprised of 7 items each measured on a four point scale. Possible scores for the depression subscale range between 0 and 21, with higher scores indicating higher levels of anxiety and depression.
measure: Pain-related fear - change from baseline to endline (4 or 8 weeks)
time frame: Baseline, following intervention (4 or 8 weeks)
description: Fear of Pain questionnaire III. On a 5-point scale, respondents are asked to rate how fearful they are of pain associated with specific situations and events (e.g., being in an automobile accident). Possible scores range between 30 and 150, with higher scores representing a more intense fear of pain. In addition to a total score, the measure also provides subscales of minor, severe, and medical pain-related fear.
measure: Sleeping impairment - change from baseline to endline (4 or 8 weeks)
time frame: Baseline, following intervention (4 or 8 weeks)
description: Medical Outcome Study Sleep Scale, a twelve-item questionnaire developed for patients with chronic illness, measuring six dimensions of sleep over the past four weeks; sleep initiation (time to fall asleep - five responses), quantity (the participant writes hours per night sleeping), maintenance, respiratory problems, perceived adequacy, and somnolence rated on a 6-point scale. A sleep problems index which summarises information from nine items is also be scored. Responses are recoded on a 0 - 100 scale, with higher scores indicating more of the concept being measured (e.g., greater difficulties falling asleep).
measure: Anxiety - change from baseline to 6-month follow-up
time frame: Baseline, 6-month follow-up
description: State and Trait Anxiety Subscales from State-Trait Anxiety Inventory(STAI), a 40-item measure of state and trait anxiety (20 items each). Each item is measured on a four point scale, with possible scores for both state and trait levels ranging between 20 and 80. State and trait subscales are not combined. Higher scores on each subscale represent more intense or more frequent feelings of anxiety.
measure: Depression - change from baseline to 6-month follow-up
time frame: Baseline, 6-month follow-up
description: Depression Subscale from Hospital Anxiety and Depression Scale, which is comprised of 7 items each measured on a four point scale. Possible scores for the depression subscale range between 0 and 21, with higher scores indicating higher levels of anxiety and depression.
measure: Pain-related fear - change from baseline to 6-month follow-up
time frame: Baseline, 6-month follow-up
description: Fear of Pain questionnaire III. On a 5-point scale, respondents are asked to rate how fearful they are of pain associated with specific situations and events (e.g., being in an automobile accident). Possible scores range between 30 and 150, with higher scores representing a more intense fear of pain. In addition to a total score, the measure also provides subscales of minor, severe, and medical pain-related fear.
measure: Sleeping impairment - change from baseline to 6-month follow-up
time frame: Baseline, 6-month follow-up
description: Medical Outcome Study Sleep Scale, a twelve-item questionnaire developed for patients with chronic illness, measuring six dimensions of sleep over the past four weeks; sleep initiation (time to fall asleep - five responses), quantity (the participant writes hours per night sleeping), maintenance, respiratory problems, perceived adequacy, and somnolence rated on a 6-point scale. A sleep problems index which summarises information from nine items is also be scored. Responses are recoded on a 0 - 100 scale, with higher scores indicating more of the concept being measured (e.g., greater difficulties falling asleep).
measure: Satisfaction with the online ABMT
time frame: Following intervention (4 or 8 weeks)
description: Satisfaction with the online treatment questionnaire. Participants state how strongly they agree/disagree with each of the following items: (a) the use of a computer to access treatment, (b) level of easiness of the online intervention, (c) duration of the potential effects of the treatment, and (d) potential recommendation of online interventions to others. Responses are provided on a 5-point scale ranging from "Agree very strongly" to "Disagree very strongly". An additional question asks participants how helpful they have found the online intervention, with responses provided on a 4-point scale ranging from "Very helpful" to "Not at all helpful". Two open questions are also included that require participants to state the aspects of the intervention they most liked and disliked.
arm group label: 10AMG
arm group type: Experimental
description: Attentional bias modification group - 10 training sessions
arm group label: 10ACG
arm group type: Placebo Comparator
description: Attentional control group - 10 placebo sessions
arm group label: 18AMG
arm group type: Experimental
description: Attentional bias modification group - 18 training sessions
arm group label: 18ACG
arm group type: Placebo Comparator
description: Attentional control group - 18 placebo sessions
intervention type: Behavioral
intervention name: Attentional bias modification training (AMG)
description: Attentional bias modification, administered via an internet-delivered visual-probe task that trains attention away from pain-related information
arm group label: 10AMG
arm group label: 18AMG
intervention type: Behavioral
intervention name: Attentional bias placebo (ACG)
description: Attentional bias placebo, administered via an internet-delivered visual-probe task that does not train attention either away or towards pain-related information
arm group label: 10ACG
arm group label: 18ACG
criteria: 
gender: All
minimum age: 16 Years
maximum age: 60 Years
healthy volunteers: No
last name: Christina Liossi, DPsych
role: Principal Investigator
affiliation: University of Southampton
last name: Christina Liossi, DPsych
phone: +44 23 8059 4645
email: c.liossi@soton.ac.uk
last name: Daniel E Schoth, PhD
phone: +44 23 8059 4518
email: d.e.schoth@soton.ac.uk
facility: 
contact: 
contact backup: 
investigator: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Musculoskeletal Pain
mesh term: Chronic Pain
sharing ipd: No