<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/NCT03287661</url>
  </required_header>
  <id_info>
    <org_study_id>P2016:145</org_study_id>
    <nct_id>NCT03287661</nct_id>
  </id_info>
  <brief_title>A Trial of an Online Chronic Pain Treatment for Military, Police and Veterans</brief_title>
  <official_title>A Randomized Controlled Trial of an Online Chronic Pain Treatment for Military, Police and Veterans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Manitoba</source>
  <oversight_info>
    <has_dmc>Yes</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 pain is a serious health issue in Canada. Individuals who experience chronic pain&#xD;
      often find it difficult to attend in-person treatment sessions for a variety of reasons&#xD;
      including pain flare-ups, discomfort when travelling, pain-induced avoidant behaviours, and&#xD;
      time constraints. These factors, if not addressed through appropriate treatment, serve as a&#xD;
      detriment to the individual's functioning by maintaining the pain cycle and preventing the&#xD;
      individual from engaging in previously enjoyed activities. Online treatments have the&#xD;
      potential to assist individuals who would otherwise have difficulty attending in-person&#xD;
      treatment sessions. This study evaluated the efficacy of an online acceptance-based&#xD;
      behavioural treatment for chronic pain designed for military, police, and veteran&#xD;
      populations. Participants (n = 29) were randomized into either a treatment condition or&#xD;
      wait-list control condition, and asked to complete a battery of measures which underscore the&#xD;
      key facets of the fear-avoidance model of chronic pain. A series of 2 x 2 mixed model ANOVA's&#xD;
      revealed statistically significant Time x Condition interactions for pain disability,&#xD;
      kinesiophobia, and pain acceptance, as well as statistically significant pre- to&#xD;
      post-treatment simple main effect contrasts for pain catastrophizing, kinesiophobia, and pain&#xD;
      acceptance. For those in the treatment group, no significant changes in scores were found&#xD;
      between post-treatment and three-month follow-up; however, the sample size was too small to&#xD;
      draw conclusions regarding this finding. Baseline PTSD and depression scores were found to be&#xD;
      significant predictors of change in pain acceptance levels over the course of treatment.&#xD;
      Overall, the results support the efficacy of the ABBT treatment for chronic pain for&#xD;
      military, police and veterans.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is an extension of a pilot study that was conducted investigating an online&#xD;
      acceptance-based behavioural therapy (ABBT) for chronic pain. The online treatment runs for a&#xD;
      total of 8 weeks and includes interactive content to promote the participant's engagement&#xD;
      with the treatment material. The treatment has been specifically tailored for military,&#xD;
      police and veteran populations as it uses language and audio vignettes to which military,&#xD;
      police and veteran individuals can easily relate. Based on promising results from a pilot&#xD;
      study conducted using the online ABBT program, the investigators conducted a randomized&#xD;
      control trial (RCT) of the treatment by randomly allocating participants into either a&#xD;
      treatment group, or a wait-list control group. Clients who are new to the participating&#xD;
      clinic participate in an intake appointment with the clinic's intake nurse, and during this&#xD;
      appointment are informed about the different research projects currently being run at the&#xD;
      clinic. Participants interested in the study were screened for inclusion and exclusion&#xD;
      criteria during their intake appointment. For this study, all eligible participants were&#xD;
      asked to complete an informed consent form prior to being issued a unique password and user&#xD;
      ID for access to the online portion of the treatment. A treatment fidelity plan and data&#xD;
      safety monitoring plan have been established to ensure treatment procedures remain consistent&#xD;
      across groups, and that data integrity is monitored over the duration of the study. The&#xD;
      treatment program is an eight module (8-week) ABBT for chronic pain. The online treatment&#xD;
      material is administered via the WebCAPSI Therapy program. This is an online&#xD;
      password-protected program which allows participants to progress through the treatment&#xD;
      modules at their own pace. Each module is designed to cover a specific component of ABBT and&#xD;
      facilitated understanding of the components through audio files, veteran, military and&#xD;
      RCMP-specific vignettes, text-based material, and homework exercises/assignments. Each module&#xD;
      is designed to be completed in 60 minutes or less and participants have the option to return&#xD;
      to the program and the modules as often as they like during the course of the treatment&#xD;
      period. On the completion of each module, and facilitated through the WebCAPSI Therapy&#xD;
      program, the participants are asked to complete a homework exercise to which they answer&#xD;
      questions previously encountered throughout the module. The principle therapist responds to&#xD;
      each homework exercise within 24-hours of its online submission, with feedback and&#xD;
      encouragement. The participants completed a battery of measures at the outset of the&#xD;
      randomization process (both treatment and wait-list control conditions), and again at the end&#xD;
      of the 8-weeks. A 3-month follow-up assessment was conducted to evaluate the maintenance of&#xD;
      treatment gains. Only participants who complete at least 5 out of the 8 modules were&#xD;
      considered to have &quot;completed&quot; the treatment, and therefore included in the analyses. The&#xD;
      interactions from the mixed model ANOVA analyses were statistically significant for changes&#xD;
      in pain interference, kinesiophobia, and pain acceptance. Regarding the main effects of Time,&#xD;
      only change in pain acceptance was found to be significant, whereas no main effect of&#xD;
      Condition was found to be statistically significant. For the treatment condition, dependent&#xD;
      t-tests were conducted to further assess mean differences between the pre-treatment,&#xD;
      post-treatment, and follow-up scores on each of the four dependent variables. The results for&#xD;
      the pre- to-post-test dependent t-tests revealed statistically significant differences for&#xD;
      all of the dependent variables except for pain interference, although even this measurement&#xD;
      was close to statistical significance with t(13) = 2.07, p = .059. As expected, there were no&#xD;
      statistically significant differences between post-treatment and follow-up for each of the&#xD;
      dependent variables. Only change in pain acceptance scores was significantly predicted by&#xD;
      participants scores on both measures of PTSD and depression symptoms. The results from this&#xD;
      study provide further empirical support for the use of acceptance-based behavioural&#xD;
      interventions for treating various chronic pain conditions, and thus add to the recent&#xD;
      growing body of literature for acceptance-based treatments for chronic pain. These results&#xD;
      also highlight how this acceptance-based behavioural treatment helps to significantly&#xD;
      decrease pain interference and kinesiophobia, as well as increase pain acceptance. This study&#xD;
      adds a unique contribution to the understanding of how depression and PTSD symptoms influence&#xD;
      treatment gains for pain acceptance, when utilizing an acceptance-based behavioural&#xD;
      intervention for chronic pain. These positive findings provide further support for the use of&#xD;
      this acceptance-based behavioural treatment for chronic pain within police and military&#xD;
      populations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 21, 2017</start_date>
  <completion_date type="Actual">September 14, 2018</completion_date>
  <primary_completion_date type="Actual">September 14, 2018</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>Randomized Controlled Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Disability Index</measure>
    <time_frame>8 weeks</time_frame>
    <description>The Pain Disability Index (PDI) is a 7-item scale which captures the respondent's perceived interference pain plays in their lives in 7 domains: family/home responsibilities recreation, social activity, occupation, sexual behavior, self-care, and life-support activity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chronic Pain Acceptance Questionnaire</measure>
    <time_frame>8 weeks</time_frame>
    <description>The Chronic Pain Acceptance Questionnaire (CPAQ), a 20-item scale designed to measure acceptance in individuals dealing with pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Pain Catastrophizing Scale</measure>
    <time_frame>8 weeks</time_frame>
    <description>The Pain Catastrophizing Scale (PCS) is a short 13-item measure which evaluates the pain-related catastrophizing behaviours and cognitions of individuals.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Tampa Scale for Kinesiophobia</measure>
    <time_frame>8 weeks</time_frame>
    <description>The Tampa Scale for Kinesiophobia (TSK-11) 11-item version is a self-report measure that contains 11 questions designed to assess a client's fear of movement and re-injury.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>D059350</condition>
  <arm_group>
    <arm_group_label>Treatment Condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An Online 8-week Acceptance-based Behavioural Therapy for chronic pain.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list Control Condition</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Wait-list Control group (8-weeks)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Acceptance-based Behavioural Therapy</intervention_name>
    <description>The treatment program is an eight module (8-week) ABBT for chronic pain. The online treatment material is administered via the WebCAPSI Therapy program. This online program allows participants to progress through the treatment modules at their own pace. Each module is designed to cover a specific component of ABBT and will facilitate understanding of the components through audio files, veteran, military and RCMP-specific vignettes, text-based material, and homework exercises/assignments. Each module is designed to be completed in 60 minutes or less. On the completion of each module, and facilitated through the WebCAPSI Therapy program, the participants are asked to complete a homework exercise to which they answer questions previously encountered throughout the module. The principle therapist responds to each homework exercise within 24-hours of its online submission.</description>
    <arm_group_label>Treatment Condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible participants will be individuals who have reported chronic pain lasting&#xD;
             longer than 6 months, and who have been referred for treatment at the OSIC.&#xD;
             Participants, male or female, will be either an active RCMP officer, an active member&#xD;
             of the Canadian Forces, or a veteran of the Canadian Forces or RCMP. The participants&#xD;
             will be required to have access to a computer with internet access for a minimum of 60&#xD;
             minutes per week.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any individual who does not meet the requirements listed above is not eligible for&#xD;
             this study. Likewise, any individual with seriously impaired concentration, psychosis,&#xD;
             suicidality, unstable living situation, or any other similar disorder or condition&#xD;
             that would render them unfit for a self-help based treatment will not be considered&#xD;
             eligible for this study. Potential participants who neither read nor write in English,&#xD;
             as well as those who are unable to provide informed consent will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Operational Stress Injury Clinic</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 16, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>September 26, 2018</last_update_submitted>
  <last_update_submitted_qc>September 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manitoba</investigator_affiliation>
    <investigator_full_name>Jeremiah Buhler</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>chronic pain</keyword>
  <keyword>online treatment</keyword>
  <keyword>acceptance-based therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <!-- 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/NCT03287661
org study id: P2016:145
nct id: NCT03287661
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Chronic pain is a serious health issue in Canada. Individuals who experience chronic pain
      often find it difficult to attend in-person treatment sessions for a variety of reasons
      including pain flare-ups, discomfort when travelling, pain-induced avoidant behaviours, and
      time constraints. These factors, if not addressed through appropriate treatment, serve as a
      detriment to the individual's functioning by maintaining the pain cycle and preventing the
      individual from engaging in previously enjoyed activities. Online treatments have the
      potential to assist individuals who would otherwise have difficulty attending in-person
      treatment sessions. This study evaluated the efficacy of an online acceptance-based
      behavioural treatment for chronic pain designed for military, police, and veteran
      populations. Participants (n = 29) were randomized into either a treatment condition or
      wait-list control condition, and asked to complete a battery of measures which underscore the
      key facets of the fear-avoidance model of chronic pain. A series of 2 x 2 mixed model ANOVA's
      revealed statistically significant Time x Condition interactions for pain disability,
      kinesiophobia, and pain acceptance, as well as statistically significant pre- to
      post-treatment simple main effect contrasts for pain catastrophizing, kinesiophobia, and pain
      acceptance. For those in the treatment group, no significant changes in scores were found
      between post-treatment and three-month follow-up; however, the sample size was too small to
      draw conclusions regarding this finding. Baseline PTSD and depression scores were found to be
      significant predictors of change in pain acceptance levels over the course of treatment.
      Overall, the results support the efficacy of the ABBT treatment for chronic pain for
      military, police and veterans.
This study is an extension of a pilot study that was conducted investigating an online
      acceptance-based behavioural therapy (ABBT) for chronic pain. The online treatment runs for a
      total of 8 weeks and includes interactive content to promote the participant's engagement
      with the treatment material. The treatment has been specifically tailored for military,
      police and veteran populations as it uses language and audio vignettes to which military,
      police and veteran individuals can easily relate. Based on promising results from a pilot
      study conducted using the online ABBT program, the investigators conducted a randomized
      control trial (RCT) of the treatment by randomly allocating participants into either a
      treatment group, or a wait-list control group. Clients who are new to the participating
      clinic participate in an intake appointment with the clinic's intake nurse, and during this
      appointment are informed about the different research projects currently being run at the
      clinic. Participants interested in the study were screened for inclusion and exclusion
      criteria during their intake appointment. For this study, all eligible participants were
      asked to complete an informed consent form prior to being issued a unique password and user
      ID for access to the online portion of the treatment. A treatment fidelity plan and data
      safety monitoring plan have been established to ensure treatment procedures remain consistent
      across groups, and that data integrity is monitored over the duration of the study. The
      treatment program is an eight module (8-week) ABBT for chronic pain. The online treatment
      material is administered via the WebCAPSI Therapy program. This is an online
      password-protected program which allows participants to progress through the treatment
      modules at their own pace. Each module is designed to cover a specific component of ABBT and
      facilitated understanding of the components through audio files, veteran, military and
      RCMP-specific vignettes, text-based material, and homework exercises/assignments. Each module
      is designed to be completed in 60 minutes or less and participants have the option to return
      to the program and the modules as often as they like during the course of the treatment
      period. On the completion of each module, and facilitated through the WebCAPSI Therapy
      program, the participants are asked to complete a homework exercise to which they answer
      questions previously encountered throughout the module. The principle therapist responds to
      each homework exercise within 24-hours of its online submission, with feedback and
      encouragement. The participants completed a battery of measures at the outset of the
      randomization process (both treatment and wait-list control conditions), and again at the end
      of the 8-weeks. A 3-month follow-up assessment was conducted to evaluate the maintenance of
      treatment gains. Only participants who complete at least 5 out of the 8 modules were
      considered to have "completed" the treatment, and therefore included in the analyses. The
      interactions from the mixed model ANOVA analyses were statistically significant for changes
      in pain interference, kinesiophobia, and pain acceptance. Regarding the main effects of Time,
      only change in pain acceptance was found to be significant, whereas no main effect of
      Condition was found to be statistically significant. For the treatment condition, dependent
      t-tests were conducted to further assess mean differences between the pre-treatment,
      post-treatment, and follow-up scores on each of the four dependent variables. The results for
      the pre- to-post-test dependent t-tests revealed statistically significant differences for
      all of the dependent variables except for pain interference, although even this measurement
      was close to statistical significance with t(13) = 2.07, p = .059. As expected, there were no
      statistically significant differences between post-treatment and follow-up for each of the
      dependent variables. Only change in pain acceptance scores was significantly predicted by
      participants scores on both measures of PTSD and depression symptoms. The results from this
      study provide further empirical support for the use of acceptance-based behavioural
      interventions for treating various chronic pain conditions, and thus add to the recent
      growing body of literature for acceptance-based treatments for chronic pain. These results
      also highlight how this acceptance-based behavioural treatment helps to significantly
      decrease pain interference and kinesiophobia, as well as increase pain acceptance. This study
      adds a unique contribution to the understanding of how depression and PTSD symptoms influence
      treatment gains for pain acceptance, when utilizing an acceptance-based behavioural
      intervention for chronic pain. These positive findings provide further support for the use of
      this acceptance-based behavioural treatment for chronic pain within police and military
      populations.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Controlled Trial
primary purpose: Treatment
masking: None (Open Label)
measure: Pain Disability Index
time frame: 8 weeks
description: The Pain Disability Index (PDI) is a 7-item scale which captures the respondent's perceived interference pain plays in their lives in 7 domains: family/home responsibilities recreation, social activity, occupation, sexual behavior, self-care, and life-support activity.
measure: Chronic Pain Acceptance Questionnaire
time frame: 8 weeks
description: The Chronic Pain Acceptance Questionnaire (CPAQ), a 20-item scale designed to measure acceptance in individuals dealing with pain.
measure: The Pain Catastrophizing Scale
time frame: 8 weeks
description: The Pain Catastrophizing Scale (PCS) is a short 13-item measure which evaluates the pain-related catastrophizing behaviours and cognitions of individuals.
measure: The Tampa Scale for Kinesiophobia
time frame: 8 weeks
description: The Tampa Scale for Kinesiophobia (TSK-11) 11-item version is a self-report measure that contains 11 questions designed to assess a client's fear of movement and re-injury.
arm group label: Treatment Condition
arm group type: Experimental
description: An Online 8-week Acceptance-based Behavioural Therapy for chronic pain.
arm group label: Wait-list Control Condition
arm group type: No Intervention
description: Wait-list Control group (8-weeks)
intervention type: Behavioral
intervention name: Acceptance-based Behavioural Therapy
description: The treatment program is an eight module (8-week) ABBT for chronic pain. The online treatment material is administered via the WebCAPSI Therapy program. This online program allows participants to progress through the treatment modules at their own pace. Each module is designed to cover a specific component of ABBT and will facilitate understanding of the components through audio files, veteran, military and RCMP-specific vignettes, text-based material, and homework exercises/assignments. Each module is designed to be completed in 60 minutes or less. On the completion of each module, and facilitated through the WebCAPSI Therapy program, the participants are asked to complete a homework exercise to which they answer questions previously encountered throughout the module. The principle therapist responds to each homework exercise within 24-hours of its online submission.
arm group label: Treatment Condition
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Manitoba
investigator full name: Jeremiah Buhler
investigator title: Principal Investigator
mesh term: Chronic Pain