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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02440490




Registration number
NCT02440490
Ethics application status
Date submitted
7/05/2015
Date registered
12/05/2015
Date last updated
23/03/2017

Titles & IDs
Public title
Optimising Cognitive Function in Patients With Chronic Pain
Scientific title
Optimising Cognitive Function in Patients With Chronic Pain
Secondary ID [1] 0 0
CF14/2985 - 2014001639
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Computerised cognitive training
Behaviour - Video watching

Experimental: Computerised cognitive training - 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.

Active Comparator: Video watching - 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.


Behaviour: Computerised cognitive training


Behaviour: Video watching
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective cognitive functioning
Timepoint [1] 0 0
8 weeks
Primary outcome [2] 0 0
Subjective cognitive functioning
Timepoint [2] 0 0
8 weeks
Secondary outcome [1] 0 0
Pain
Timepoint [1] 0 0
8 weeks
Secondary outcome [2] 0 0
Mood and coping
Timepoint [2] 0 0
8 weeks
Secondary outcome [3] 0 0
Heart rate variability
Timepoint [3] 0 0
8 weeks

Eligibility
Key inclusion criteria
- Chronic pain condition

- Access to computer and internet
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2017
Sample size
Target
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash University - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Alfred
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Sydney
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02440490
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Melita Giummarra, PhD
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02440490