Pain Self-management Program for Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Depression; Chronic Pain; Anxiety
• Intervention / Treatment: Behavioral: Online Group; Behavioral: Workbook Group

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 Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4S 0A2
      • University of Regina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Online Group; 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.	Behavioral: Online Group; An 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in an online format.
Experimental: Workbook Group; 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.	Behavioral: Workbook Group; An 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in a printed (workbook) format.
No Intervention: Wait List Control Group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the impact of pain in several areas of life	Measured by Pain Disability Index (PDI)	baseline, 8 weeks, 3 months
Change in depression	Measured by Geriatric Depression Scale-30 (GDS-30)	baseline, 8 weeks, 3 months
Change in anxiety	Measured by Generalized Anxiety Disorder Scale 7-Item (GAD-7)	baseline, 8 weeks, 3 months
Change in chronic pain severity	Measured by Brief Pain Inventory (BPI)	baseline, 8 weeks, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in beliefs about one's ability to perform every day tasks regardless of chronic pain	Measured by Pain Self-Efficacy Questionnaire (PSEQ)	baseline, 8 weeks, 3 months
Change in fear of movement or re-injury	Measured by TAMPA Scale of Kinesiophobia (TSK)	baseline, 8 weeks, 3 months
Change in acceptance of chronic pain	Measured by Chronic Pain Acceptance Questionnaire (CPAQ-8)	baseline, 8 weeks, 3 months
Change in tendency to amplify the threat value of constant pain	Measured by Pain Catastrophizing Scale (PCS)	baseline, 8 weeks, 3 months
Treatment satisfaction	Measured by Treatment Satisfaction Questions (TSQ) used in Pain Course	8 weeks

Collaborators and Investigators

• Sponsor: University of Regina
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Thomas Hadjistavropoulos, University of Regina; Principal Investigator: Heather Hadjistavropoulos, University of Regina

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2018
• Primary Completion (Actual): April 20, 2019
• Study Completion (Actual): April 20, 2019

Study Registration Dates

• First Submitted: April 18, 2018
• First Submitted That Met QC Criteria: April 18, 2018
• First Posted (Actual): April 30, 2018

Study Record Updates

• Last Update Posted (Actual): November 20, 2019
• Last Update Submitted That Met QC Criteria: November 19, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: chronic pain; online; remote delivery; pain self-management; workbook
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 2018-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No