View in EDS HTML Full Text PDF Full Text

A randomised controlled feasibility trial of intermittent theta burst stimulation with an open longer‐term follow‐up for young people with persistent anorexia nervosa (RaISE): Study protocol.

Saved in:
Bibliographic Details
Title: A randomised controlled feasibility trial of intermittent theta burst stimulation with an open longer‐term follow‐up for young people with persistent anorexia nervosa (RaISE): Study protocol.
Authors: Hemmings, Amelia (AUTHOR), Gallop, Lucy (AUTHOR), İnce, Başak (AUTHOR), Cutinha, Darren (AUTHOR), Kan, Carol (AUTHOR), Simic, Mima (AUTHOR), Zadeh, Ewa (AUTHOR), Malvisi, Isabella (AUTHOR), McKenzie, Katie (AUTHOR), Zocek, Lucy (AUTHOR), Sharpe, Helen (AUTHOR), O'Daly, Owen (AUTHOR), Campbell, Iain C. (AUTHOR), Schmidt, Ulrike (AUTHOR)
Source: European Eating Disorders Review. May2024, Vol. 32 Issue 3, p575-588. 14p.
Subjects: Anorexia nervosa treatment, Pilot projects, Statistical sampling, Treatment effectiveness, Randomized controlled trials, Transcranial magnetic stimulation
Abstract: Objective: We present the protocol of a feasibility randomised controlled trial (RCT) of intermittent theta burst stimulation (iTBS) for young people with anorexia nervosa (AN). Effective first‐line psychological therapies exist for young people with AN, but little is known about how to treat those who do not respond. Non‐invasive neuromodulation, such as iTBS, could address unmet treatment needs by targeting neurocircuitry associated with the development and/or maintenance of AN. Design: Sixty‐six young people (aged 13–30 years) with persistent AN will be randomly allocated to receive 20 sessions of real or sham iTBS over the left dorsolateral prefrontal cortex in addition to their usual treatment. Outcomes will be measured at baseline, post‐treatment (1‐month post‐randomisation) and 4‐months post‐randomisation (when unblinding will occur). Additional open follow‐ups will be conducted at 12‐ and 24‐months post‐randomisation. The primary feasibility outcome is the proportion of participants retained in the study at 4‐months. Secondary outcomes include AN symptomatology, other psychopathology, quality of life, service utilisation, neurocognitive processes, and neuroimaging measures. Discussion: Findings will inform the development of a future large‐scale RCT. They will also provide exploratory data on treatment efficacy, and neural and neurocognitive predictors and correlates of treatment response to iTBS in AN. HIGHLIGHTS: This paper presents a study protocol of a triple‐blind feasibility randomised controlled trial (RCT) with an open longer‐term follow‐up, using intermittent theta burst stimulation (iTBS) for young people with AN.It provides a clinical and scientific rationale for conducting a neuromodulation RCT in eating disorders.It is hoped that the findings will inform the development of a future large‐scale RCT investigating the clinical efficacy of iTBS for AN. [ABSTRACT FROM AUTHOR]
Copyright of European Eating Disorders Review is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
Full text is not displayed to guests.
FullText Links:
  – Type: pdflink
Text:
  Availability: 1
Header DbId: pbh
DbLabel: Psychology and Behavioral Sciences Collection
An: 176450665
AccessLevel: 6
PubType: Academic Journal
PubTypeId: academicJournal
PreciseRelevancyScore: 0
IllustrationInfo
Items – Name: Title
  Label: Title
  Group: Ti
  Data: A randomised controlled feasibility trial of intermittent theta burst stimulation with an open longer‐term follow‐up for young people with persistent anorexia nervosa (RaISE): Study protocol.
– Name: Author
  Label: Authors
  Group: Au
  Data: <searchLink fieldCode="AR" term="%22Hemmings%2C+Amelia%22">Hemmings, Amelia</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Gallop%2C+Lucy%22">Gallop, Lucy</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22İnce%2C+Başak%22">İnce, Başak</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Cutinha%2C+Darren%22">Cutinha, Darren</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kan%2C+Carol%22">Kan, Carol</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Simic%2C+Mima%22">Simic, Mima</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Zadeh%2C+Ewa%22">Zadeh, Ewa</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Malvisi%2C+Isabella%22">Malvisi, Isabella</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22McKenzie%2C+Katie%22">McKenzie, Katie</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Zocek%2C+Lucy%22">Zocek, Lucy</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Sharpe%2C+Helen%22">Sharpe, Helen</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22O'Daly%2C+Owen%22">O'Daly, Owen</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Campbell%2C+Iain+C%2E%22">Campbell, Iain C.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Schmidt%2C+Ulrike%22">Schmidt, Ulrike</searchLink> (AUTHOR)
– Name: TitleSource
  Label: Source
  Group: Src
  Data: <searchLink fieldCode="JN" term="%22European+Eating+Disorders+Review%22">European Eating Disorders Review</searchLink>. May2024, Vol. 32 Issue 3, p575-588. 14p.
– Name: Subject
  Label: Subjects
  Group: Su
  Data: <searchLink fieldCode="DE" term="%22Anorexia+nervosa+treatment%22">Anorexia nervosa treatment</searchLink><br /><searchLink fieldCode="DE" term="%22Pilot+projects%22">Pilot projects</searchLink><br /><searchLink fieldCode="DE" term="%22Statistical+sampling%22">Statistical sampling</searchLink><br /><searchLink fieldCode="DE" term="%22Treatment+effectiveness%22">Treatment effectiveness</searchLink><br /><searchLink fieldCode="DE" term="%22Randomized+controlled+trials%22">Randomized controlled trials</searchLink><br /><searchLink fieldCode="DE" term="%22Transcranial+magnetic+stimulation%22">Transcranial magnetic stimulation</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Objective: We present the protocol of a feasibility randomised controlled trial (RCT) of intermittent theta burst stimulation (iTBS) for young people with anorexia nervosa (AN). Effective first‐line psychological therapies exist for young people with AN, but little is known about how to treat those who do not respond. Non‐invasive neuromodulation, such as iTBS, could address unmet treatment needs by targeting neurocircuitry associated with the development and/or maintenance of AN. Design: Sixty‐six young people (aged 13–30 years) with persistent AN will be randomly allocated to receive 20 sessions of real or sham iTBS over the left dorsolateral prefrontal cortex in addition to their usual treatment. Outcomes will be measured at baseline, post‐treatment (1‐month post‐randomisation) and 4‐months post‐randomisation (when unblinding will occur). Additional open follow‐ups will be conducted at 12‐ and 24‐months post‐randomisation. The primary feasibility outcome is the proportion of participants retained in the study at 4‐months. Secondary outcomes include AN symptomatology, other psychopathology, quality of life, service utilisation, neurocognitive processes, and neuroimaging measures. Discussion: Findings will inform the development of a future large‐scale RCT. They will also provide exploratory data on treatment efficacy, and neural and neurocognitive predictors and correlates of treatment response to iTBS in AN. HIGHLIGHTS: This paper presents a study protocol of a triple‐blind feasibility randomised controlled trial (RCT) with an open longer‐term follow‐up, using intermittent theta burst stimulation (iTBS) for young people with AN.It provides a clinical and scientific rationale for conducting a neuromodulation RCT in eating disorders.It is hoped that the findings will inform the development of a future large‐scale RCT investigating the clinical efficacy of iTBS for AN. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: <i>Copyright of European Eating Disorders Review is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=pbh&AN=176450665
RecordInfo BibRecord:
  BibEntity:
    Identifiers:
      – Type: doi
        Value: 10.1002/erv.3073
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        PageCount: 14
        StartPage: 575
    Subjects:
      – SubjectFull: Anorexia nervosa treatment
        Type: general
      – SubjectFull: Pilot projects
        Type: general
      – SubjectFull: Statistical sampling
        Type: general
      – SubjectFull: Treatment effectiveness
        Type: general
      – SubjectFull: Randomized controlled trials
        Type: general
      – SubjectFull: Transcranial magnetic stimulation
        Type: general
    Titles:
      – TitleFull: A randomised controlled feasibility trial of intermittent theta burst stimulation with an open longer‐term follow‐up for young people with persistent anorexia nervosa (RaISE): Study protocol.
        Type: main
  BibRelationships:
    HasContributorRelationships:
      – PersonEntity:
          Name:
            NameFull: Hemmings, Amelia
      – PersonEntity:
          Name:
            NameFull: Gallop, Lucy
      – PersonEntity:
          Name:
            NameFull: İnce, Başak
      – PersonEntity:
          Name:
            NameFull: Cutinha, Darren
      – PersonEntity:
          Name:
            NameFull: Kan, Carol
      – PersonEntity:
          Name:
            NameFull: Simic, Mima
      – PersonEntity:
          Name:
            NameFull: Zadeh, Ewa
      – PersonEntity:
          Name:
            NameFull: Malvisi, Isabella
      – PersonEntity:
          Name:
            NameFull: McKenzie, Katie
      – PersonEntity:
          Name:
            NameFull: Zocek, Lucy
      – PersonEntity:
          Name:
            NameFull: Sharpe, Helen
      – PersonEntity:
          Name:
            NameFull: O'Daly, Owen
      – PersonEntity:
          Name:
            NameFull: Campbell, Iain C.
      – PersonEntity:
          Name:
            NameFull: Schmidt, Ulrike
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 01
              M: 05
              Text: May2024
              Type: published
              Y: 2024
          Identifiers:
            – Type: issn-print
              Value: 10724133
          Numbering:
            – Type: volume
              Value: 32
            – Type: issue
              Value: 3
          Titles:
            – TitleFull: European Eating Disorders Review
              Type: main
ResultId 1