Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Optimising Cognitive Function in Patients With Chronic Pain

21 mars 2017 uppdaterad av: Katharine Baker, Monash University
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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

39

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Melbourne, Australien
        • Monash University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Aktiv komparator: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Objective cognitive functioning
Tidsram: 8 weeks
Composite of neuropsychological test scores
8 weeks
Subjective cognitive functioning
Tidsram: 8 weeks
Self-report measures of cognition
8 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pain
Tidsram: 8 weeks
Pain intensity and interference from the Brief Pain Inventory
8 weeks
Mood and coping
Tidsram: 8 weeks
Self-report measures of anxiety, depression, pain catastrophizing and pain self-efficacy
8 weeks
Heart rate variability
Tidsram: 8 weeks
Electrophysiological measure
8 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Samarbetspartners

Utredare

  • Huvudutredare: Melita Giummarra, PhD, Monash University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 maj 2015

Primärt slutförande (Faktisk)

1 februari 2017

Avslutad studie (Faktisk)

1 februari 2017

Studieregistreringsdatum

Först inskickad

7 maj 2015

Först inskickad som uppfyllde QC-kriterierna

7 maj 2015

Första postat (Uppskatta)

12 maj 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 mars 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 mars 2017

Senast verifierad

1 mars 2017

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CF14/2985 - 2014001639

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Kronisk smärta

Kliniska prövningar på Computerised cognitive training

Prenumerera