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Optimising Cognitive Function in Patients With Chronic Pain

21. mars 2017 oppdatert 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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

39

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Melbourne, Australia
        • Monash University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Objective cognitive functioning
Tidsramme: 8 weeks
Composite of neuropsychological test scores
8 weeks
Subjective cognitive functioning
Tidsramme: 8 weeks
Self-report measures of cognition
8 weeks

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Melita Giummarra, PhD, Monash University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2015

Primær fullføring (Faktiske)

1. februar 2017

Studiet fullført (Faktiske)

1. februar 2017

Datoer for studieregistrering

Først innsendt

7. mai 2015

Først innsendt som oppfylte QC-kriteriene

7. mai 2015

Først lagt ut (Anslag)

12. mai 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. mars 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. mars 2017

Sist bekreftet

1. mars 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CF14/2985 - 2014001639

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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