Pain Self-management Program for Older Adults

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Pain, Depression, Anxiety

Intervention / Treatment
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* Behavioral: Online Group
* Behavioral: Workbook Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remote delivery, workbook, online, chronic pain, pain self-management