Chronic PainNCT01600248
Online Chronic Pain Therapy for Adults
A study testing Online ABBT for Chronic Pain in Military in people with Chronic Pain, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Online ABBT for Chronic Pain in Military
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to Feb 2015
- 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
- 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
Who cannot join
- Active psychosis
- Actively suicidal
- Unstable living conditions
- Seriously impaired concentration
- Inability to read and write in English
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Online ABBT for Chronic Pain in Military
- Keywords
- Chronic Pain, Military, Veteran, Online, Acceptance
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online ABBT for Chronic Pain in MilitaryBehavioural
Participants will complete an 8-module, self-paced, online program for chronic pain using Acceptance-Based Behavioural Therapy (ABBT) as the therapeutic modality.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Other | This is an open-label pilot study with no control group. Participants pre-treatment scores are compared to their post-treatment scores. Receives: Behavioral: Online ABBT for Chronic Pain in Military |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in McGill Pain Questionnaire - Short Form
A brief self-report questionnaire that measures sensory and affective components of clinical pain.
Measured: 8 weeks
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".
Measured: 8 weeks
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."
Measured: 8 weeks
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"
Measured: 8 weeks
Change from baseline in Pittsburgh Sleep Quality Index
A self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval
Measured: 8 weeks
Secondary outcomes (4)
Client Satisfaction Questionnaire
An eight item questionnaire regarding client satisfaction with the treatment.
Measured: At completion of module, approximately 8 weeks
Change from baseline in Beck Depression Inventory - Second Edition
A 21 item self-report measure of severity of depressive symptoms.
Measured: 3 months
Change from baseline in Beck Anxiety Inventory
A 21-item self-report measure assessing severity of symptoms of anxiety
Measured: 3 months
Change from baseline in PTSD Checklist - Military Version
A 17-item self-report measure assessing severity of PTSD symptoms related to stressful military experiences.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startJun 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pamela L Holens, Ph.D., Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600248
- Sponsor's protocol ID
- H2012:078
- Status last verified
- Aug 2015
- First submitted
- 10 May 2012
- Last updated
- 21 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Chronic Pain Therapy for Adults
- ClinicalTrials.gov ID
- NCT01600248
- Acronym / sponsor ID
- H2012:078
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, Military, Veteran, Online, Acceptance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 17 May 2012 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Other | Behavioral: Online ABBT for Chronic Pain in MilitaryThis is an open-label pilot study with no control group. Participants pre-treatment scores are compared to their post-treatment scores. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Active psychosis
- Actively suicidal
- Unstable living conditions
- Seriously impaired concentration
- Inability to read and write in English
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 |
|---|---|---|
| Online ABBT for Chronic Pain in MilitaryParticipants will complete an 8-module, self-paced, online program for chronic pain using Acceptance-Based Behavioural Therapy (ABBT) as the therapeutic modality. | Behavioural | Treatment arm |
Primary outcome
Change from baseline in McGill Pain Questionnaire - Short Form
Time frame: 8 weeks
A brief self-report questionnaire that measures sensory and affective components of clinical pain.
Change from baseline in Chronic Pain Acceptance Questionnaire - Revised
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Time frame: 8 weeks
A self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval
4 secondary outcomes
Client Satisfaction Questionnaire
Time frame: At completion of module, approximately 8 weeks
Change from baseline in Beck Depression Inventory - Second Edition
Time frame: 3 months
Change from baseline in Beck Anxiety Inventory
Time frame: 3 months
Change from baseline in PTSD Checklist - Military Version
Time frame: 3 months
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 21 Aug 2015.
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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.
Pamela L Holens, Ph.D. principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online ABBT for Chronic Pain in Military in people with Chronic Pain, 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 3 inclusion and 5 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 21 Aug 2015. 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?
Change from baseline in McGill Pain Questionnaire - Short Form (time frame: 8 weeks). The study lists 5 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 21 Aug 2015.