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Completed

NCT Number: NCT03512522

Pain Self-management Program for Older Adults

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.

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Key information

Conditions

Chronic Pain Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Online Group

Behavioral

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

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.

Primary outcomes

  1. Change in the impact of pain in several areas of life

    Time frame: baseline, 8 weeks, 3 months

    Measured by Pain Disability Index (PDI)

  2. Change in depression

    Time frame: baseline, 8 weeks, 3 months

    Measured by Geriatric Depression Scale-30 (GDS-30)

  3. Change in anxiety

    Time frame: baseline, 8 weeks, 3 months

    Measured by Generalized Anxiety Disorder Scale 7-Item (GAD-7)

  4. Change in chronic pain severity

    Time frame: baseline, 8 weeks, 3 months

    Measured by Brief Pain Inventory (BPI)

Secondary outcomes

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

    Time frame: baseline, 8 weeks, 3 months

    Measured by Pain Self-Efficacy Questionnaire (PSEQ)

  2. Change in fear of movement or re-injury

    Time frame: baseline, 8 weeks, 3 months

    Measured by TAMPA Scale of Kinesiophobia (TSK)

  3. Change in acceptance of chronic pain

    Time frame: baseline, 8 weeks, 3 months

    Measured by Chronic Pain Acceptance Questionnaire (CPAQ-8)

  4. Change in tendency to amplify the threat value of constant pain

    Time frame: baseline, 8 weeks, 3 months

    Measured by Pain Catastrophizing Scale (PCS)

  5. Treatment satisfaction

    Time frame: 8 weeks

    Measured by Treatment Satisfaction Questions (TSQ) used in Pain Course

Sponsors and collaborators

Lead sponsor

University of Regina

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 30, 2018
Registry last updated
Nov 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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