D059350NCT03287661
A Trial of an Online Chronic Pain Treatment for Military, Police and Veterans
A study testing Acceptance-based Behavioural Therapy in people with D059350, run by University of Manitoba at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- D059350
- What is being tested?
- Acceptance-based Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- 21 Sep 2017to 14 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- D059350
- Being tested
- Acceptance-based Behavioural Therapy
- Keywords
- chronic pain, online treatment, acceptance-based therapy
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance-based Behavioural TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Condition | Experimental | An Online 8-week Acceptance-based Behavioural Therapy for chronic pain. Receives: Behavioral: Acceptance-based Behavioural Therapy |
| Wait-list Control Condition | No intervention | Wait-list Control group (8-weeks) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Disability Index
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.
Measured: 8 weeks
Chronic Pain Acceptance Questionnaire
The Chronic Pain Acceptance Questionnaire (CPAQ), a 20-item scale designed to measure acceptance in individuals dealing with pain.
Measured: 8 weeks
The Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS) is a short 13-item measure which evaluates the pain-related catastrophizing behaviours and cognitions of individuals.
Measured: 8 weeks
The Tampa Scale for Kinesiophobia
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start21 Sep 2017
- Primary completion14 Sep 2018
- Study completion14 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for D059350Studies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremiah Buhler, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287661
- Sponsor's protocol ID
- P2016:145
- Status last verified
- Sep 2018
- First submitted
- 16 Sep 2017
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of an Online Chronic Pain Treatment for Military, Police and Veterans
- ClinicalTrials.gov ID
- NCT03287661
- Acronym / sponsor ID
- P2016:145
- Conditions
- D059350
- Keywords
- chronic pain, online treatment, acceptance-based therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- 14 Sep 2018 (actual)
- First posted
- 19 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Treatment Condition | Experimental | Behavioral: Acceptance-based Behavioural TherapyAn Online 8-week Acceptance-based Behavioural Therapy for chronic pain. |
| Wait-list Control Condition | No intervention | –Wait-list Control group (8-weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance-based Behavioural TherapyThe 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. | Behavioural | Treatment Condition |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance-based Behavioural Therapy in people with D059350, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Disability Index (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2018; AzTrials last refreshed its copy on 8 Nov 2026.