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Optimising Cognitive Function in Patients With Chronic Pain

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Computerised cognitive training
Video watching
Sponsored by
Monash University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic pain condition
  • Access to computer and internet

Exclusion Criteria:

  • High dosages of opioid or benzodiazepine medication
  • Currently receiving active allied health treatment
  • Intellectual disability, traumatic brain injury, dementia, or other neurological disorders

Sites / Locations

  • Monash University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Computerised cognitive training

Video watching

Arm Description

The cognitive training protocol will be run using pre-validated software, HappyNeuronPro, that delivers cognitive 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 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. Each video is followed by multiple-choice questions that participants will answer, to ensure attention was engaged. The videos are visually stimulating and engaging, but involve no increment in difficulty or requirement to improve skills. They may provide some distraction from pain and may be relaxing, interesting and informative.

Outcomes

Primary Outcome Measures

Objective cognitive functioning
Composite of neuropsychological test scores
Subjective cognitive functioning
Self-report measures of cognition

Secondary Outcome Measures

Pain
Pain intensity and interference from the Brief Pain Inventory
Mood and coping
Self-report measures of anxiety, depression, pain catastrophizing and pain self-efficacy
Heart rate variability
Electrophysiological measure

Full Information

First Posted
May 7, 2015
Last Updated
March 21, 2017
Sponsor
Monash University
Collaborators
The Alfred, University of Sydney
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1. Study Identification

Unique Protocol Identification Number
NCT02440490
Brief Title
Optimising Cognitive Function in Patients With Chronic Pain
Official Title
Optimising Cognitive Function in Patients With Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Monash University
Collaborators
The Alfred, University of Sydney

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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: Can neurocognitive abilities be improved? Can such improvements bring about better daily functioning in general? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computerised cognitive training
Arm Type
Experimental
Arm Description
The cognitive training protocol will be run using pre-validated software, HappyNeuronPro, that delivers cognitive 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.
Arm Title
Video watching
Arm Type
Active Comparator
Arm Description
This 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. Each video is followed by multiple-choice questions that participants will answer, to ensure attention was engaged. The videos are visually stimulating and engaging, but involve no increment in difficulty or requirement to improve skills. They may provide some distraction from pain and may be relaxing, interesting and informative.
Intervention Type
Behavioral
Intervention Name(s)
Computerised cognitive training
Intervention Type
Behavioral
Intervention Name(s)
Video watching
Primary Outcome Measure Information:
Title
Objective cognitive functioning
Description
Composite of neuropsychological test scores
Time Frame
8 weeks
Title
Subjective cognitive functioning
Description
Self-report measures of cognition
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Pain
Description
Pain intensity and interference from the Brief Pain Inventory
Time Frame
8 weeks
Title
Mood and coping
Description
Self-report measures of anxiety, depression, pain catastrophizing and pain self-efficacy
Time Frame
8 weeks
Title
Heart rate variability
Description
Electrophysiological measure
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic pain condition Access to computer and internet Exclusion Criteria: High dosages of opioid or benzodiazepine medication Currently receiving active allied health treatment Intellectual disability, traumatic brain injury, dementia, or other neurological disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melita Giummarra, PhD
Organizational Affiliation
Monash University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Monash University
City
Melbourne
Country
Australia

12. IPD Sharing Statement

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Optimising Cognitive Function in Patients With Chronic Pain

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