Clinical trial NCT03512522: Pain Self-management Program for Older Adults
Official title: A Pain Self-management Program for Older Adults: Online vs. Workbook Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Depression
Anxiety
Keywords: chronic pain
pain self-management
remote delivery
workbook
online
Lead sponsor: University of Regina
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2018-04-30
Enrollment: 121
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in the impact of pain in several areas of life
timeFrame: baseline, 8 weeks, 3 months
measure: Change in depression
timeFrame: baseline, 8 weeks, 3 months
measure: Change in anxiety
timeFrame: baseline, 8 weeks, 3 months
measure: Change in chronic pain severity
timeFrame: baseline, 8 weeks, 3 months
Secondary outcomes:
measure: Change in beliefs about one's ability to perform every day tasks regardless of chronic pain
timeFrame: baseline, 8 weeks, 3 months
measure: Change in fear of movement or re-injury
timeFrame: baseline, 8 weeks, 3 months
measure: Change in acceptance of chronic pain
timeFrame: baseline, 8 weeks, 3 months
measure: Change in tendency to amplify the threat value of constant pain
timeFrame: baseline, 8 weeks, 3 months
measure: Treatment satisfaction
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Regina
country: Canada
facility: University of Regina
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Thomas Hadjistavropoulos
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Regina
name: Heather Hadjistavropoulos
role: PRINCIPAL_INVESTIGATOR
References: