Pain Self-management Program for Older Adults

NCT03512522 | Completed

• 1 other identifier: 2018-004
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Depression; Anxiety

Keywords

chronic pain; pain self-management; remote delivery; workbook; online

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Change in beliefs about one's ability to perform every day tasks regardless of chronic pain

  baseline, 8 weeks, 3 months

• Change in fear of movement or re-injury

  baseline, 8 weeks, 3 months

• Change in acceptance of chronic pain

  baseline, 8 weeks, 3 months

• Change in tendency to amplify the threat value of constant pain

  baseline, 8 weeks, 3 months

• Treatment satisfaction

  8 weeks

Study Arms (3)

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.

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.

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.

Interventions

Online Group BEHAVIORAL

An 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in an online format.

Online Group

Workbook Group BEHAVIORAL

An 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in a printed (workbook) format.

Workbook Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Regina: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

Location

MeSH Terms

Conditions

Chronic Pain; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Thomas Hadjistavropoulos

  University of Regina

  PRINCIPAL INVESTIGATOR

• Heather Hadjistavropoulos

  University of Regina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: April 30, 2018
• Study Start: February 23, 2018
• Primary Completion: April 20, 2019
• Study Completion: April 20, 2019
• Last Updated: November 20, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)