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Adapting dose–response methodology to improve clinical trial design for psychotherapies.

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Title: Adapting dose–response methodology to improve clinical trial design for psychotherapies.
Authors: Sysko, Robyn, Holland, Katherine, Hildebrandt, Tom
Source: International Journal of Eating Disorders. Jun2024, Vol. 57 Issue 6, p1322-1329. 8p.
Subjects: Treatment of eating disorders, Psychotherapy, Treatment effectiveness, Disease remission, Randomized controlled trials, Dose-response relationship in biochemistry, Experimental design, Quality of life, Comorbidity, Time
Abstract: Objective: Conventional randomized controlled trials (RCTs) have long served as the foundation of research in clinical psychology; however, most treatments for eating disorders show only modest effects on reduction of symptoms and maintenance of long‐term remission. New options for psychotherapy treatment development research, beyond continuing to pursue additive or subpopulation approaches, are needed. Methods: One option is to apply dose–response designs, which are commonplace in studies of pharmacology, toxicology, and medical research, and characterized by the evaluation of the amount of exposure (dose) to an intervention, and the resulting changes in body function or health (response). Results: Eating disorder interventions are particularly well‐suited for dose–response treatment designs. The deadly nature of eating disorders makes it imperative that patients are not turned away for not being "ready" to engage with treatment. By identifying optimal doses, research will likely yield a more parsimonious course of treatment, which will lend itself to reduced costs, greater uptake, and reduced drop‐out. Discussion: Limited use of within‐subject designs in trials for patients with eating disorders has produced fast‐track efficacy studies and omitted key elements in the treatment development pathway. To decrease reliance on RCT's, dose–response methods should be applied as an alternative study design. Public Significance: Eating disorders are associated with medical and psychiatric comorbidities, poor quality of life, and high mortality. Access to evidence‐based services for patients with eating disorders is limited, and identifying additional effective treatment options can be difficult because of challenges inherent to randomized‐controlled trials. This manuscript describes an alternative trial methodology to maximize the information that can be gathered prior to utilizing a standard large‐scale efficacy design. [ABSTRACT FROM AUTHOR]
Copyright of International Journal of Eating Disorders 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
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  Data: Adapting dose–response methodology to improve clinical trial design for psychotherapies.
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  Data: <searchLink fieldCode="AR" term="%22Sysko%2C+Robyn%22">Sysko, Robyn</searchLink><br /><searchLink fieldCode="AR" term="%22Holland%2C+Katherine%22">Holland, Katherine</searchLink><br /><searchLink fieldCode="AR" term="%22Hildebrandt%2C+Tom%22">Hildebrandt, Tom</searchLink>
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  Data: <searchLink fieldCode="JN" term="%22International+Journal+of+Eating+Disorders%22">International Journal of Eating Disorders</searchLink>. Jun2024, Vol. 57 Issue 6, p1322-1329. 8p.
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  Data: <searchLink fieldCode="DE" term="%22Treatment+of+eating+disorders%22">Treatment of eating disorders</searchLink><br /><searchLink fieldCode="DE" term="%22Psychotherapy%22">Psychotherapy</searchLink><br /><searchLink fieldCode="DE" term="%22Treatment+effectiveness%22">Treatment effectiveness</searchLink><br /><searchLink fieldCode="DE" term="%22Disease+remission%22">Disease remission</searchLink><br /><searchLink fieldCode="DE" term="%22Randomized+controlled+trials%22">Randomized controlled trials</searchLink><br /><searchLink fieldCode="DE" term="%22Dose-response+relationship+in+biochemistry%22">Dose-response relationship in biochemistry</searchLink><br /><searchLink fieldCode="DE" term="%22Experimental+design%22">Experimental design</searchLink><br /><searchLink fieldCode="DE" term="%22Quality+of+life%22">Quality of life</searchLink><br /><searchLink fieldCode="DE" term="%22Comorbidity%22">Comorbidity</searchLink><br /><searchLink fieldCode="DE" term="%22Time%22">Time</searchLink>
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  Label: Abstract
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  Data: Objective: Conventional randomized controlled trials (RCTs) have long served as the foundation of research in clinical psychology; however, most treatments for eating disorders show only modest effects on reduction of symptoms and maintenance of long‐term remission. New options for psychotherapy treatment development research, beyond continuing to pursue additive or subpopulation approaches, are needed. Methods: One option is to apply dose–response designs, which are commonplace in studies of pharmacology, toxicology, and medical research, and characterized by the evaluation of the amount of exposure (dose) to an intervention, and the resulting changes in body function or health (response). Results: Eating disorder interventions are particularly well‐suited for dose–response treatment designs. The deadly nature of eating disorders makes it imperative that patients are not turned away for not being "ready" to engage with treatment. By identifying optimal doses, research will likely yield a more parsimonious course of treatment, which will lend itself to reduced costs, greater uptake, and reduced drop‐out. Discussion: Limited use of within‐subject designs in trials for patients with eating disorders has produced fast‐track efficacy studies and omitted key elements in the treatment development pathway. To decrease reliance on RCT's, dose–response methods should be applied as an alternative study design. Public Significance: Eating disorders are associated with medical and psychiatric comorbidities, poor quality of life, and high mortality. Access to evidence‐based services for patients with eating disorders is limited, and identifying additional effective treatment options can be difficult because of challenges inherent to randomized‐controlled trials. This manuscript describes an alternative trial methodology to maximize the information that can be gathered prior to utilizing a standard large‐scale efficacy design. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of International Journal of Eating Disorders 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.)
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        Value: 10.1002/eat.24120
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      – Code: eng
        Text: English
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        PageCount: 8
        StartPage: 1322
    Subjects:
      – SubjectFull: Treatment of eating disorders
        Type: general
      – SubjectFull: Psychotherapy
        Type: general
      – SubjectFull: Treatment effectiveness
        Type: general
      – SubjectFull: Disease remission
        Type: general
      – SubjectFull: Randomized controlled trials
        Type: general
      – SubjectFull: Dose-response relationship in biochemistry
        Type: general
      – SubjectFull: Experimental design
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      – SubjectFull: Quality of life
        Type: general
      – SubjectFull: Comorbidity
        Type: general
      – SubjectFull: Time
        Type: general
    Titles:
      – TitleFull: Adapting dose–response methodology to improve clinical trial design for psychotherapies.
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            NameFull: Sysko, Robyn
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            NameFull: Holland, Katherine
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            NameFull: Hildebrandt, Tom
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          Dates:
            – D: 01
              M: 06
              Text: Jun2024
              Type: published
              Y: 2024
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