- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01600248
Online Chronic Pain Therapy for Adults
August 19, 2015 updated by: University of Manitoba
This study will evaluate the usefulness of an online, self-directed treatment for chronic pain that has been designed specifically for individuals who are currently or have previously served in the military.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will evaluate the efficacy of an eight-module, online, self-directed treatment for chronic pain using Acceptance-Based Behavioural Therapy (ABBT) as the treatment modality.
The online modules are tailored to the unique issues of individuals with a military background.
The modules will be delivered via the WebCAPSI Therapy program, an online, password-protected program that allows participants to anonymously progress through all modules at their own pace.
ABBT modules cover the following: Introduction, Acceptance, Values, Cognitive Defusion, Mindfulness, Exercise/Pacing/Communication Skills, Self-as-Context, and Willingness.
Modules encourage understanding of the information through audio files, military-specific vignettes, written materials, and homework exercises.
Modules are designed to be completed in 60 minutes or less.
Participants will have access to the online treatment for a three month period and will be encouraged to complete one module per week.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- 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
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Manitoba
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Winnipeg, Manitoba, Canada, R3J 0L3
- OSI Clinic, Deer Lodge Centre
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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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Chronic pain condition of duration 6 months or longer
- Patient at OSI Clinic in Winnipeg
- Access to a computer with internet at least once per week for 60 minutes
Exclusion Criteria:
- Active psychosis
- Actively suicidal
- Unstable living conditions
- Seriously impaired concentration
- Inability to read and write in English
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Treatment arm
This is an open-label pilot study with no control group.
Participants pre-treatment scores are compared to their post-treatment scores.
|
Participants will complete an 8-module, self-paced, online program for chronic pain using Acceptance-Based Behavioural Therapy (ABBT) as the therapeutic modality.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in McGill Pain Questionnaire - Short Form
Time Frame: 8 weeks
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A brief self-report questionnaire that measures sensory and affective components of clinical pain.
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8 weeks
|
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Change from baseline in Chronic Pain Acceptance Questionnaire - Revised
Time Frame: 8 weeks
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A 20-item measure of acceptance of chronic pain with items scored from "0 = Never true" to "6 = Always true".
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8 weeks
|
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Change from baseline in Pain Catastrophizing Scale
Time Frame: 8 weeks
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One of the most widely used instruments for measuring catastrophic thinking related to pain.
A 13-item measure with items rated from "0 = Not at all" to "4 = All the time."
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8 weeks
|
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Change from baseline in Tampa Scale for Kinesiophobia
Time Frame: 8 weeks
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A self-report measure of fear of movement and/or re-injury.
17 items rated from "1 = strongly disagree" to "4 = strongly agree"
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8 weeks
|
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Change from baseline in Pittsburgh Sleep Quality Index
Time Frame: 8 weeks
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A self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Client Satisfaction Questionnaire
Time Frame: At completion of module, approximately 8 weeks
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An eight item questionnaire regarding client satisfaction with the treatment.
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At completion of module, approximately 8 weeks
|
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Change from baseline in Beck Depression Inventory - Second Edition
Time Frame: 3 months
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A 21 item self-report measure of severity of depressive symptoms.
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3 months
|
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Change from baseline in Beck Anxiety Inventory
Time Frame: 3 months
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A 21-item self-report measure assessing severity of symptoms of anxiety
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3 months
|
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Change from baseline in PTSD Checklist - Military Version
Time Frame: 3 months
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A 17-item self-report measure assessing severity of PTSD symptoms related to stressful military experiences.
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pamela L Holens, Ph.D., 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
June 1, 2012
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
May 10, 2012
First Submitted That Met QC Criteria
May 14, 2012
First Posted (Estimate)
May 17, 2012
Study Record Updates
Last Update Posted (Estimate)
August 21, 2015
Last Update Submitted That Met QC Criteria
August 19, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H2012:078
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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