Optimising Cognitive Function in Patients With Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      Cognitive difficulties often occur with chronic pain. The aim of this randomised controlled
      trial is to determine whether various aspects of cognitive function can be improved. An
      8-week course of cognitive training via a web-based training program (3 times per week) will
      be contrasted with watching informative documentary videos (for the same length of time).
      Outcomes include subjective and objective measures of cognition, as well as self-report
      measures of mood and pain.
    

Detailed description: 
      Rationale for project:

      Cognitive difficulties may occur with chronic pain, potentially indicative of compromised
      functioning in frontal brain regions, which also results in greater difficulty controlling
      pain, with increased rumination and worry. Discovering a successful method for strengthening
      these neural systems may improve cognitive skills important for daily life and maximise
      therapeutic outcomes.

      Research questions:

      In people experiencing cognitive deficits due to their pain condition:

        1. Can neurocognitive abilities be improved?

        2. Can such improvements bring about better daily functioning in general?

        3. If these training protocols improve cognition, will there also be an effect of pain
           reduction, i.e., in the extent to which pain interferes with a person's life?

      Aim:

      The overarching aim of this research is to determine whether cognitive function can be
      improved via a training protocol in people experiencing cognitive difficulties related to
      chronic pain.

      Design:

      This is a randomised controlled trial examining the effects of cognitive training compared
      with an active control. The investigators aim to enrol 40 participants with chronic pain in
      the study: 20 training, and 20 active control. This sample size was chosen based on a power
      analysis with moderate effect size, and is consistent with sample sizes in the existing
      cognitive training literature, though no similar study has so far been done in a chronic pain
      population. Both groups will complete their respective study activities 3 times per week, for
      45 minutes each time, across 8 weeks. They will be assessed before completing the 8-week
      period, and again within a few days of completion.

      Procedures:

      40 participants will be recruited via the Caulfield Pain Management and Research Centre.

      After deciding to participate and meeting all inclusion criteria, participants will be
      invited to attend their first on-site assessment session at Monash University, Clayton. The
      first assessment session will include an overview of the training program and demonstration
      of how to do the tasks, or an overview of the active control activities (as applicable). Both
      assessment sessions will involve detailed assessment of cognition, pain, and mood.

      The cognitive training protocol will be run using pre-validated software that delivers brain
      training "games". The games are designed to be visually interesting and engaging, and are
      varied so that each session will comprise multiple different games, to avoid boredom. They
      begin with easy-to-follow instructions and demonstrations, then as the participant
      progresses, the difficulty is automatically increased in correspondence with their
      performance, to avoid ceiling or plateau effects. Participants will be assigned a program
      targeting multiple facets of cognition found to be compromised in chronic pain states,
      including divided attention, working memory, mentally planning a sequence of items to form a
      pattern or complete a puzzle, and response inhibition.

      This software is accessible via the internet on desktop and laptop computers, or on tablet
      devices. All training sessions will be completed at home. The researchers will hold a master
      account, allowing them to log in and monitor participant progress and compliance with the
      training.

      The active control group will be provided with a variety of videos to watch, the content of
      which will be in the style of documentaries on general interest topics such as nature,
      travel, culture, and history. These are also visually stimulating and engaging, but involve
      no increment in difficulty. They may provide distraction from pain and may be relaxing.

      Throughout the protocol, the researchers will have weekly contact with participants by phone
      or video call. Keeping regular contact in this way will maintain engagement with the research
      team, help boost motivation and allow participants to express any issues they may be having
      with the protocol.
    

Intervention name(s): Computerised cognitive training; Video watching
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment