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Completed

NCT Number: NCT05319652

Feasibility Study of an Online Self-management Program for Chronic Non-cancer Pain

Based on a mixed-methods design, the objective of this trial is to assess the feasibility and acceptability of the "Agir pour moi" program, an 8-week online self-management program for chronic non-cancer pain (CNCP). The investigators will also explore its potential effects on self-efficacy, pain interference, pain severity, anxiety, depression, catastrophizing, and global impression of change in adults with CNCP awaiting services from a chronic pain multidisciplinary treatment center.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Québec

Québec, Quebec, G1V 4G2, Canada

About this study

The mixed-methods sequential explanatory design combines a quantitative questionnaire-based study with a subsequent in depth qualitative approach.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years;
  • live with CNCP for more than 3 months;
  • read and understand French easily;
  • have access to a computer and high-speed Internet;
  • be available to take part in the project for 6 to 8 months;
  • not having started a new treatment for pain within the last month;
  • agree to notify the team before starting a new treatment;
  • be able to give informed consent.

Exclusion criteria

  • be supported by a multidisciplinary treatment center or be likely to be in the short term;
  • having participated in a CNCP self-management program within the last year;
  • be awaiting scheduled surgical treatment within six months.

Treatment and study plan

Pain self-management program

Behavioral

Each week for eight weeks, participants are invited to complete self-directed lessons on particular themes. The program covers goal setting, stress management through relaxation, breathing and mindfulness, pacing, physical activity, thoughts and emotions, sleep, nutrition, flare-up management, and planning. Through pain education, positive testimonials from individuals with CNCP applying the suggested strategies, reflective activities, goal setting and monitoring, and the gradual development of a personal plan, the program supports self-efficacy building to manage CNCP.

Primary outcomes

  1. Feasibility of the recruitment

    Time frame: Baseline

    • Number of potentially eligible adults referred by the multidisciplinary treatment center over the recruitment period
    • Number of referred adults who respond to the invitation
    • Number of referred adults who consent to participate in the study
    • Number of interested adults excluded based on inclusion/exclusion criteria

  2. Feasibility of data collection

    Time frame: Baseline

    • Rate of response to the questionnaires
    • Rate of completed questionnaires (no missing data)

  3. Feasibility of data collection

    Time frame: Post-intervention (8 weeks)

    • Rate of response to the questionnaires
    • Rate of completed questionnaires (no missing data)

  4. Feasibility of data collection

    Time frame: 3 months post-intervention

    • Rate of response to the questionnaires
    • Rate of completed questionnaires (no missing data)

  5. Acceptability

    Time frame: Post-intervention (8 Weeks)

    The Acceptability E-scale includes 6 items regarding how easy and enjoyable the program was to use, how understandable were the lessons, how helpful was completing the program, whether the participant liked the program, whether the amount of time to complete the program was acceptable, and overall satisfaction with the program. Scores can range from 6 to 30. Higher scores reprensent a high level of acceptability.

  6. Acceptability

    Time frame: 4 months post-intervention

    Qualitative data from semi-structured interviews

  7. Adherence to the program

    Time frame: Post-intervention (8 weeks)

    Completion rate of the program (completion is following ≥ 75% of the lessons)

Secondary outcomes

  1. Change in self-efficacy: French version of the Pain Self-Efficacy Questionnaire (PSEQ)

    Time frame: Baseline; Post-intervention (8 weeks); 3 months post-intervention

    The PSEQ is a ten item questionnaire which assesses an individual's confidence in their ability to perform a variety of activities or tasks despite pain. Scores can range from 0 to 60. Higher scores represent lower confidence to function with pain.

  2. Change in pain severity and pain interference: French version of the Brief Pain Inventory (BPI)

    Time frame: Baseline; Post-intervention (8 weeks); 3 months post-intervention

    The BPI includes a pain severity subscale and a pain interference subscale. The pain interference subscale measures the extent to which pain interferes with functions such as general activity, walking ability, normal work, mood, relationships with people, enjoyment of life and sleep. For each scale, the total score is the average of all items. Scores can range from 0 to 10 for each subscale. Higher scores indicate greater severity and more interference.

  3. Change in anxiety and depression: French version of the Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline; Post-intervention (8 weeks); 3 months post-intervention

    The HADS is a 14-item scale. Seven items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.

  4. Change in pain catastrophizing: French version of the Pain Catastrophizing Scale (PCS)

    Time frame: Baseline; Post-intervention (8 weeks); 3 months post-intervention

    The PCS is a 13-item questionnaire designed to assess catastrophic thinking in relation to pain. It yields a total score and three subscale scores assessing rumination, magnification and helplessness. Scores can range from 0 to 52. Higher scores represent higher pain catastrophizing.

  5. Patient Global Impression of Change Scale (PGIC)

    Time frame: Post-intervention (8 weeks); 3 months post-intervention

    The PGIC measures a patient's rating of overall improvement or lack thereof due to the intervention. It is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Registry information

Official study title

Co-development and Assessment of the Feasibility and Potential Effects of an Online Self-management Program for Chronic Non-cancer Pain

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 8, 2022
Registry last updated
Jul 24, 2023

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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