Back to resultsOnline Chronic Pain Therapy for Adults
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Online ABBT for Chronic Pain in Military
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Chronic Pain, Military, Veteran, Online, Acceptance
Eligibility Criteria
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
Sites / Locations
- OSI Clinic, Deer Lodge Centre
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Treatment arm
Arm Description
This is an open-label pilot study with no control group. Participants pre-treatment scores are compared to their post-treatment scores.
Outcomes
Primary Outcome Measures
Change from baseline in McGill Pain Questionnaire - Short Form
A brief self-report questionnaire that measures sensory and affective components of clinical pain.
Change from baseline in Chronic Pain Acceptance Questionnaire - Revised
A 20-item measure of acceptance of chronic pain with items scored from "0 = Never true" to "6 = Always true".
Change from baseline in Pain Catastrophizing Scale
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."
Change from baseline in Tampa Scale for Kinesiophobia
A self-report measure of fear of movement and/or re-injury. 17 items rated from "1 = strongly disagree" to "4 = strongly agree"
Change from baseline in Pittsburgh Sleep Quality Index
A self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval
Secondary Outcome Measures
Client Satisfaction Questionnaire
An eight item questionnaire regarding client satisfaction with the treatment.
Change from baseline in Beck Depression Inventory - Second Edition
A 21 item self-report measure of severity of depressive symptoms.
Change from baseline in Beck Anxiety Inventory
A 21-item self-report measure assessing severity of symptoms of anxiety
Change from baseline in PTSD Checklist - Military Version
A 17-item self-report measure assessing severity of PTSD symptoms related to stressful military experiences.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01600248
Brief Title
Online Chronic Pain Therapy for Adults
Official Title
Online Chronic Pain Therapy for Adults
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic Pain, Military, Veteran, Online, Acceptance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment arm
Arm Type
Other
Arm Description
This is an open-label pilot study with no control group. Participants pre-treatment scores are compared to their post-treatment scores.
Intervention Type
Behavioral
Intervention Name(s)
Online ABBT for Chronic Pain in Military
Intervention Description
Participants will complete an 8-module, self-paced, online program for chronic pain using Acceptance-Based Behavioural Therapy (ABBT) as the therapeutic modality.
Primary Outcome Measure Information:
Title
Change from baseline in McGill Pain Questionnaire - Short Form
Description
A brief self-report questionnaire that measures sensory and affective components of clinical pain.
Time Frame
8 weeks
Title
Change from baseline in Chronic Pain Acceptance Questionnaire - Revised
Description
A 20-item measure of acceptance of chronic pain with items scored from "0 = Never true" to "6 = Always true".
Time Frame
8 weeks
Title
Change from baseline in Pain Catastrophizing Scale
Description
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."
Time Frame
8 weeks
Title
Change from baseline in Tampa Scale for Kinesiophobia
Description
A self-report measure of fear of movement and/or re-injury. 17 items rated from "1 = strongly disagree" to "4 = strongly agree"
Time Frame
8 weeks
Title
Change from baseline in Pittsburgh Sleep Quality Index
Description
A self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Client Satisfaction Questionnaire
Description
An eight item questionnaire regarding client satisfaction with the treatment.
Time Frame
At completion of module, approximately 8 weeks
Title
Change from baseline in Beck Depression Inventory - Second Edition
Description
A 21 item self-report measure of severity of depressive symptoms.
Time Frame
3 months
Title
Change from baseline in Beck Anxiety Inventory
Description
A 21-item self-report measure assessing severity of symptoms of anxiety
Time Frame
3 months
Title
Change from baseline in PTSD Checklist - Military Version
Description
A 17-item self-report measure assessing severity of PTSD symptoms related to stressful military experiences.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela L Holens, Ph.D.
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
OSI Clinic, Deer Lodge Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3J 0L3
Country
Canada
12. IPD Sharing Statement
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Online Chronic Pain Therapy for Adults
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