A Trial of an Online Chronic Pain Treatment for Military, Police and Veterans

September 26, 2018 updated by: Jeremiah Buhler, University of Manitoba

A Randomized Controlled Trial of an Online Chronic Pain Treatment for Military, Police and Veterans

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Operational Stress Injury Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Eligible participants will be individuals who have reported chronic pain lasting longer than 6 months, and who have been referred for treatment at the OSIC. Participants, male or female, will be either an active RCMP officer, an active member of the Canadian Forces, or a veteran of the Canadian Forces or RCMP. The participants will be required to have access to a computer with internet access for a minimum of 60 minutes per week.

Exclusion Criteria:

  • Any individual who does not meet the requirements listed above is not eligible for this study. Likewise, any individual with seriously impaired concentration, psychosis, suicidality, unstable living situation, or any other similar disorder or condition that would render them unfit for a self-help based treatment will not be considered eligible for this study. Potential participants who neither read nor write in English, as well as those who are unable to provide informed consent will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Condition
An Online 8-week Acceptance-based Behavioural Therapy for chronic pain.
Behavioral: Acceptance-based Behavioural Therapy
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.
No Intervention: Wait-list Control Condition
Wait-list Control group (8-weeks)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Disability Index
Time Frame: 8 weeks
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.
8 weeks
Chronic Pain Acceptance Questionnaire
Time Frame: 8 weeks
The Chronic Pain Acceptance Questionnaire (CPAQ), a 20-item scale designed to measure acceptance in individuals dealing with pain.
8 weeks
The Pain Catastrophizing Scale
Time Frame: 8 weeks
The Pain Catastrophizing Scale (PCS) is a short 13-item measure which evaluates the pain-related catastrophizing behaviours and cognitions of individuals.
8 weeks
The Tampa Scale for Kinesiophobia
Time Frame: 8 weeks
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 14, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 14, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P2016:145

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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