Chronic PainNCT03512522
Pain Self-management Program for Older Adults
A study testing Online Group and Workbook Group in people with Chronic Pain and Depression, run by University of Regina at 1 site in Canada.
Trial summary
It is well documented that severe pain is more common in older adults than it is younger persons. Of concern, older adults may not have access to traditional face-to-face self-management programs, which are recognized to be valuable in chronic pain management. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Pain, Depression, Anxiety
- What is being tested?
- Online Group and Workbook Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteCanada
- Study dates
- 23 Feb 2018to 20 Apr 2019
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- are residents of Canada
- are 65 years of age or older
- report experiencing pain for more than three months
- are not experiencing very severe symptoms of depression or anxiety
- have regular access to a computer and the internet
- are proficient in writing and speaking the English language
Who cannot join
- high suicide risk
- concerns about online therapy
- not present in the country during treatment
- are younger than 65 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pain Self-management Program for Older Adults: Online vs. Workbook Delivery
It is well documented that severe pain is more common in older adults than it is younger persons. Of concern, older adults may not have access to traditional face-to-face self-management programs, which are recognized to be valuable in chronic pain management. Access to effective self-management approaches is particularly important for older adults who may have mobility limitations or live in remote areas, or have difficulty accessing health care services. The development of effective pain self-management programs for older adults who cannot access traditional psychological interventions is of significant importance. Internet self-management programs have the potential to address pain undermanagement. As technology advances, the digital divide between the older and younger demographic continues to progress. Given the known difficulties with treatment access, the purpose of this study is to explore the efficacy and acceptability of a remotely-delivered chronic pain self-management program tailored to older adults, the Pain Course, when delivered in online and workbook formats. The program was previously shown to be effective among younger persons but has not been tested with older adults.
Read the detailed description
The program is delivered through a secure platform administered by the Online Therapy Unit for Service Education and Research at the University of Regina. Using a patient preference randomized control trial (RCT) design, participants (n = 120) will be enrolled in either the online group or workbook group, or to a wait list control group. The content of both programs will be identical and contain 5 core lessons, which participants will be encouraged to work through over an 8-week period. By exploring the efficacy of an online vs. workbook group, the results from this study may serve as a stepping-stone for improved self-management of chronic pain in older adults.
A patient preference randomized controlled trial (RCT) was chosen for this study. The goal is to have most participants accept randomization by emphasizing they are equally acceptable, so only those with a very strong preference or no access to Internet aren't randomized. According to the preliminary power analysis, a total of 120 participants will be randomly assigned to be enrolled in the online group or workbook group, or be placed on a twelve-week wait list control, which will serve as a control group to control for the influence of time on symptom change between groups.
- Conditions
- Chronic Pain, Depression, Anxiety
- Being tested
- Online Group, Workbook Group
- Keywords
- chronic pain, pain self-management, remote delivery, workbook, online
- Medical subject headings
- Chronic Pain, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online GroupBehavioural
An 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in an online format.
Workbook GroupBehavioural
An 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in a printed (workbook) format.
| Study group | Role | What they receive |
|---|---|---|
| Online Group | Experimental | An 8-week remotely-delivered pain self-management program tailored to older adults that have been experiencing pain for at least three months. Participants randomized to the Online Group will receive access to the course on the computer (online). A researcher will act as a guide who provides general support and encouragement, as opposed to a clinician who would offer comprehensive therapy. The guide will aim to contact participants weekly via telephone for approximately 5 to 10 minutes. Receives: Behavioral: Online Group |
| Workbook Group | Experimental | An 8-week remotely-delivered pain self-management program tailored to older adults that have been experiencing pain for at least three months. Participants randomized to the Workbook Group will receive access to the course in a printed (workbook) format. A researcher will act as a guide who provides general support and encouragement, as opposed to a clinician who would offer comprehensive therapy. The guide will aim to contact participants weekly via telephone for approximately 5 to 10 minutes. Receives: Behavioral: Workbook Group |
| Wait List Control Group | No intervention | Participants who are randomly allocated to the wait list control group will be provided access to the course after the twelve-week period has passed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the impact of pain in several areas of life
Measured by Pain Disability Index (PDI)
Measured: baseline, 8 weeks, 3 months
Change in depression
Measured by Geriatric Depression Scale-30 (GDS-30)
Measured: baseline, 8 weeks, 3 months
Change in anxiety
Measured by Generalized Anxiety Disorder Scale 7-Item (GAD-7)
Measured: baseline, 8 weeks, 3 months
Change in chronic pain severity
Measured by Brief Pain Inventory (BPI)
Measured: baseline, 8 weeks, 3 months
Secondary outcomes (5)
Change in beliefs about one's ability to perform every day tasks regardless of chronic pain
Measured by Pain Self-Efficacy Questionnaire (PSEQ)
Measured: baseline, 8 weeks, 3 months
Change in fear of movement or re-injury
Measured by TAMPA Scale of Kinesiophobia (TSK)
Measured: baseline, 8 weeks, 3 months
Change in acceptance of chronic pain
Measured by Chronic Pain Acceptance Questionnaire (CPAQ-8)
Measured: baseline, 8 weeks, 3 months
Change in tendency to amplify the threat value of constant pain
Measured by Pain Catastrophizing Scale (PCS)
Measured: baseline, 8 weeks, 3 months
Treatment satisfaction
Measured by Treatment Satisfaction Questions (TSQ) used in Pain Course
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 posted30 Apr 2018
- Study start23 Feb 2018
- Primary completion20 Apr 2019
- Study completion20 Apr 2019
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.
- 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
- A patient preference randomized controlled trial (RCT) will be used for this study. Participants will be randomly assigned to be enrolled in the online group or workbook group, or be placed on a twelve-week wait list control, which will serve as a control group to control for the influence of time on symptom change between groups.
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Thomas Hadjistavropoulos, Principal investigator, University of ReginaHeather Hadjistavropoulos, Principal investigator, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512522
- Sponsor's protocol ID
- 2018-004
- Status last verified
- Nov 2019
- First submitted
- 18 Apr 2018
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pain Self-management Program for Older Adults: Online vs. Workbook Delivery
- ClinicalTrials.gov ID
- NCT03512522
- Acronym / sponsor ID
- 2018-004
- Conditions
- Chronic Pain, Depression, Anxiety
- Keywords
- chronic pain, pain self-management, remote delivery, workbook, online
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 20 Apr 2019 (actual)
- Study completion
- 20 Apr 2019 (actual)
- First posted
- 30 Apr 2018 (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.
It is well documented that severe pain is more common in older adults than it is younger persons. Of concern, older adults may not have access to traditional face-to-face self-management programs, which are recognized to be valuable in chronic pain management. Access to effective self-management approaches is particularly important for older adults who may have mobility limitations or live in remote areas, or have difficulty accessing health care services. The development of effective pain self-management programs for older adults who cannot access traditional psychological interventions is of significant importance. Internet self-management programs have the potential to address pain undermanagement. As technology advances, the digital divide between the older and younger demographic continues to progress. Given the known difficulties with treatment access, the purpose of this study is to explore the efficacy and acceptability of a remotely-delivered chronic pain self-management program tailored to older adults, the Pain Course, when delivered in online and workbook formats. The program was previously shown to be effective among younger persons but has not been tested with older adults.
Detailed description
The program is delivered through a secure platform administered by the Online Therapy Unit for Service Education and Research at the University of Regina. Using a patient preference randomized control trial (RCT) design, participants (n = 120) will be enrolled in either the online group or workbook group, or to a wait list control group. The content of both programs will be identical and contain 5 core lessons, which participants will be encouraged to work through over an 8-week period. By exploring the efficacy of an online vs. workbook group, the results from this study may serve as a stepping-stone for improved self-management of chronic pain in older adults.
A patient preference randomized controlled trial (RCT) was chosen for this study. The goal is to have most participants accept randomization by emphasizing they are equally acceptable, so only those with a very strong preference or no access to Internet aren't randomized. According to the preliminary power analysis, a total of 120 participants will be randomly assigned to be enrolled in the online group or workbook group, or be placed on a twelve-week wait list control, which will serve as a control group to control for the influence of time on symptom change between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A patient preference randomized controlled trial (RCT) will be used for this study. Participants will be randomly assigned to be enrolled in the online group or workbook group, or be placed on a twelve-week wait list control, which will serve as a control group to control for the influence of time on symptom change between groups.
| Arm | Type | Receives |
|---|---|---|
| Online Group | Experimental | Behavioral: Online GroupAn 8-week remotely-delivered pain self-management program tailored to older adults that have been experiencing pain for at least three months. Participants randomized to the Online Group will receive access to the course on the computer (online). A researcher will act as a guide who provides general support and encouragement, as opposed to a clinician who would offer comprehensive therapy. The guide will aim to contact participants weekly via telephone for approximately 5 to 10 minutes. |
| Workbook Group | Experimental | Behavioral: Workbook GroupAn 8-week remotely-delivered pain self-management program tailored to older adults that have been experiencing pain for at least three months. Participants randomized to the Workbook Group will receive access to the course in a printed (workbook) format. A researcher will act as a guide who provides general support and encouragement, as opposed to a clinician who would offer comprehensive therapy. The guide will aim to contact participants weekly via telephone for approximately 5 to 10 minutes. |
| Wait List Control Group | No intervention | –Participants who are randomly allocated to the wait list control group will be provided access to the course after the twelve-week period has passed. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- are residents of Canada
- are 65 years of age or older
- report experiencing pain for more than three months
- are not experiencing very severe symptoms of depression or anxiety
- have regular access to a computer and the internet
Key exclusion criteria (4 listed)
- high suicide risk
- concerns about online therapy
- not present in the country during treatment
- are younger than 65 years of age
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 GroupAn 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in an online format. | Behavioural | Online Group |
| Workbook GroupAn 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in a printed (workbook) format. | Behavioural | Workbook Group |
Primary outcome
Change in the impact of pain in several areas of life
Time frame: baseline, 8 weeks, 3 months
Measured by Pain Disability Index (PDI)
Change in depression
Time frame: baseline, 8 weeks, 3 months
Measured by Geriatric Depression Scale-30 (GDS-30)
Change in anxiety
Time frame: baseline, 8 weeks, 3 months
Measured by Generalized Anxiety Disorder Scale 7-Item (GAD-7)
Change in chronic pain severity
Time frame: baseline, 8 weeks, 3 months
Measured by Brief Pain Inventory (BPI)
5 secondary outcomes
Change in beliefs about one's ability to perform every day tasks regardless of chronic pain
Time frame: baseline, 8 weeks, 3 months
Change in fear of movement or re-injury
Time frame: baseline, 8 weeks, 3 months
Change in acceptance of chronic pain
Time frame: baseline, 8 weeks, 3 months
Change in tendency to amplify the threat value of constant pain
Time frame: baseline, 8 weeks, 3 months
Treatment satisfaction
Time frame: 8 weeks
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 20 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Thomas Hadjistavropoulos principal investigator
University of Regina
Heather Hadjistavropoulos principal investigator
University of Regina
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 Group and Workbook Group in people with Chronic Pain and Depression, run by University of Regina 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 6 inclusion and 4 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 20 Nov 2019. 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 in the impact of pain in several areas of life (time frame: baseline, 8 weeks, 3 months). 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 20 Nov 2019.