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Pain Self-management Program for Older Adults

Primary Purpose

Chronic Pain, Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Online Group
Workbook Group
Sponsored by
University of Regina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring chronic pain, pain self-management, remote delivery, workbook, online

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • high suicide risk
  • concerns about online therapy
  • not present in the country during treatment
  • are younger than 65 years of age

Sites / Locations

  • University of Regina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Online Group

Workbook Group

Wait List Control Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in the impact of pain in several areas of life
Measured by Pain Disability Index (PDI)
Change in depression
Measured by Geriatric Depression Scale-30 (GDS-30)
Change in anxiety
Measured by Generalized Anxiety Disorder Scale 7-Item (GAD-7)
Change in chronic pain severity
Measured by Brief Pain Inventory (BPI)

Secondary Outcome Measures

Change in beliefs about one's ability to perform every day tasks regardless of chronic pain
Measured by Pain Self-Efficacy Questionnaire (PSEQ)
Change in fear of movement or re-injury
Measured by TAMPA Scale of Kinesiophobia (TSK)
Change in acceptance of chronic pain
Measured by Chronic Pain Acceptance Questionnaire (CPAQ-8)
Change in tendency to amplify the threat value of constant pain
Measured by Pain Catastrophizing Scale (PCS)
Treatment satisfaction
Measured by Treatment Satisfaction Questions (TSQ) used in Pain Course

Full Information

First Posted
April 18, 2018
Last Updated
November 19, 2019
Sponsor
University of Regina
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT03512522
Brief Title
Pain Self-management Program for Older Adults
Official Title
A Pain Self-management Program for Older Adults: Online vs. Workbook Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 23, 2018 (Actual)
Primary Completion Date
April 20, 2019 (Actual)
Study Completion Date
April 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Regina
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Depression, Anxiety
Keywords
chronic pain, pain self-management, remote delivery, workbook, online

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Online Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Workbook Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait List Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online Group
Intervention Description
An 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in an online format.
Intervention Type
Behavioral
Intervention Name(s)
Workbook Group
Intervention Description
An 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in a printed (workbook) format.
Primary Outcome Measure Information:
Title
Change in the impact of pain in several areas of life
Description
Measured by Pain Disability Index (PDI)
Time Frame
baseline, 8 weeks, 3 months
Title
Change in depression
Description
Measured by Geriatric Depression Scale-30 (GDS-30)
Time Frame
baseline, 8 weeks, 3 months
Title
Change in anxiety
Description
Measured by Generalized Anxiety Disorder Scale 7-Item (GAD-7)
Time Frame
baseline, 8 weeks, 3 months
Title
Change in chronic pain severity
Description
Measured by Brief Pain Inventory (BPI)
Time Frame
baseline, 8 weeks, 3 months
Secondary Outcome Measure Information:
Title
Change in beliefs about one's ability to perform every day tasks regardless of chronic pain
Description
Measured by Pain Self-Efficacy Questionnaire (PSEQ)
Time Frame
baseline, 8 weeks, 3 months
Title
Change in fear of movement or re-injury
Description
Measured by TAMPA Scale of Kinesiophobia (TSK)
Time Frame
baseline, 8 weeks, 3 months
Title
Change in acceptance of chronic pain
Description
Measured by Chronic Pain Acceptance Questionnaire (CPAQ-8)
Time Frame
baseline, 8 weeks, 3 months
Title
Change in tendency to amplify the threat value of constant pain
Description
Measured by Pain Catastrophizing Scale (PCS)
Time Frame
baseline, 8 weeks, 3 months
Title
Treatment satisfaction
Description
Measured by Treatment Satisfaction Questions (TSQ) used in Pain Course
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: high suicide risk concerns about online therapy not present in the country during treatment are younger than 65 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Hadjistavropoulos
Organizational Affiliation
University of Regina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heather Hadjistavropoulos
Organizational Affiliation
University of Regina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Regina
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4S 0A2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Pain Self-management Program for Older Adults

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