Pain Self-management Program for Older Adults

Depression Clinical Trial

Official title:

A Pain Self-management Program for Older Adults: Online vs. Workbook Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03512522
• Other study ID #: 2018-004
• Status: Completed
• Phase: N/A
• Start date: February 23, 2018
• Est. completion date: April 20, 2019

Study information

• Verified date: November 2019
• Source: University of Regina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: April 20, 2019
• Est. primary completion date: April 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Chronic Pain
• Depression

Intervention

Behavioral:
• Online Group
An 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in an online format.
• Workbook Group
An 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in a printed (workbook) format.

Locations

Country	Name	City	State
Canada	University of Regina	Regina	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
University of Regina	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the impact of pain in several areas of life	Measured by Pain Disability Index (PDI)	baseline, 8 weeks, 3 months
Primary	Change in depression	Measured by Geriatric Depression Scale-30 (GDS-30)	baseline, 8 weeks, 3 months
Primary	Change in anxiety	Measured by Generalized Anxiety Disorder Scale 7-Item (GAD-7)	baseline, 8 weeks, 3 months
Primary	Change in chronic pain severity	Measured by Brief Pain Inventory (BPI)	baseline, 8 weeks, 3 months
Secondary	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
Secondary	Change in fear of movement or re-injury	Measured by TAMPA Scale of Kinesiophobia (TSK)	baseline, 8 weeks, 3 months
Secondary	Change in acceptance of chronic pain	Measured by Chronic Pain Acceptance Questionnaire (CPAQ-8)	baseline, 8 weeks, 3 months
Secondary	Change in tendency to amplify the threat value of constant pain	Measured by Pain Catastrophizing Scale (PCS)	baseline, 8 weeks, 3 months
Secondary	Treatment satisfaction	Measured by Treatment Satisfaction Questions (TSQ) used in Pain Course	8 weeks