NCT02440490

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 23, 2017

Status Verified

March 1, 2017

Enrollment Period

1.8 years

First QC Date

May 7, 2015

Last Update Submit

March 21, 2017

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (2)

  • Objective cognitive functioning

    Composite of neuropsychological test scores

    8 weeks

  • Subjective cognitive functioning

    Self-report measures of cognition

    8 weeks

Secondary Outcomes (3)

  • Pain

    8 weeks

  • Mood and coping

    8 weeks

  • Heart rate variability

    8 weeks

Study Arms (2)

Computerised cognitive training

EXPERIMENTAL

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.

Behavioral: Computerised cognitive training

Video watching

ACTIVE COMPARATOR

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.

Behavioral: Video watching

Interventions

Computerised cognitive trainingBEHAVIORAL
Computerised cognitive training
Video watchingBEHAVIORAL
Video watching

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic pain condition
  • Access to computer and internet

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monash University

Melbourne, Australia

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Melita Giummarra, PhD

    Monash University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Katharine Baker

Study Record Dates

First Submitted

May 7, 2015

First Posted

May 12, 2015

Study Start

May 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

March 23, 2017

Record last verified: 2017-03

Locations

AU(1)