NCT03287661

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

September 21, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2018

Completed
Last Updated

September 28, 2018

Status Verified

September 1, 2018

Enrollment Period

12 months

First QC Date

September 16, 2017

Last Update Submit

September 26, 2018

Conditions

Keywords

chronic painonline treatmentacceptance-based therapy

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    8 weeks

Study Arms (2)

Treatment Condition

EXPERIMENTAL

An Online 8-week Acceptance-based Behavioural Therapy for chronic pain.

Behavioral: Acceptance-based Behavioural Therapy

Wait-list Control Condition

NO INTERVENTION

Wait-list Control group (8-weeks)

Interventions

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.

Treatment Condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Operational Stress Injury Clinic

Winnipeg, Manitoba, Canada

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 16, 2017

First Posted

September 19, 2017

Study Start

September 21, 2017

Primary Completion

September 14, 2018

Study Completion

September 14, 2018

Last Updated

September 28, 2018

Record last verified: 2018-09

Locations