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Effects of open-label placebos on test performance and psychological well-being in healthy medical students: a randomized controlled trial.

ABSTRACT: Psychological distress is prevalent in students and can predispose to psychiatric disorders. Recent findings indicate that distress might be linked to impaired cognitive performance in students. Experimental findings in healthy participants suggest that placebo interventions can improve cognition. However, whether non-deceptive (i.e., open-label, OLP) placebos can enhance cognitive function and emotional well-being is unclear. Using a randomized-controlled design we demonstrate a positive impact of OLP on subjective well-being (i.e., stress, fatigue, and confusion) after a 21-day OLP application in healthy students during midterm exams. OLP did not improve test performance, but, within the OLP group, test performance was positively correlated with measures of general belief in the benefit of medication. These results show that OLP can counteract negative effects of acute stress on psychological well-being and might improve cognitive performance if supported by positive treatment expectations. Additionally, our findings in healthy volunteers warrant further investigation in exploring the potential of OLP in reducing stress-related psychological effects in patients. The trial was preregistered at the German Clinical Trials Register on December 20, 2017 (DRKS00013557).

SUBMITTER: Kleine-Borgmann J

PROVIDER: S-EPMC7822842 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Effects of open-label placebos on test performance and psychological well-being in healthy medical students: a randomized controlled trial.

Kleine-Borgmann Julian J Schmidt Katharina K Billinger Marieke M Forkmann Katarina K Wiech Katja K Bingel Ulrike U

Scientific reports 20210122 1

Psychological distress is prevalent in students and can predispose to psychiatric disorders. Recent findings indicate that distress might be linked to impaired cognitive performance in students. Experimental findings in healthy participants suggest that placebo interventions can improve cognition. However, whether non-deceptive (i.e., open-label, OLP) placebos can enhance cognitive function and emotional well-being is unclear. Using a randomized-controlled design we demonstrate a positive impact ...[more]

PMID: 33483552

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Project description:BackgroundThe efficacy of open-label placebos (OLPs) has been increasingly demonstrated and their use holds promise for applications compatible with basic ethical principles. Taking this concept one step further an imaginary pill (IP) intervention without the use of a physical pill was developed and tested in a randomized controlled trial (RCT). To explore participants' experiences and views, we conducted the first qualitative study in the field of IPs.MethodsA reflexive thematic analysis (RTA) of semi-structured interviews with test anxious students (N = 20) was nested in an RCT investigating an IP and OLP intervention. In addition, open-ended questions from the RCT were evaluated (N = 114) to corroborate the RTA and pill characteristics were included to more accurately capture the IP experience.ResultsFour key themes were identified: (1) attitude towards the intervention, (2) applicability of the intervention, (3) experience of effects, and (4) characteristics of the imagination. The IP intervention was well-accepted, easily applicable, and various effects, pill characteristics and appearances were described. While many participants did not desire a physical pill, either due to the absence of the imagination component or aversion to pills, the approach was considered to be cognitively and time demanding, which in turn, however, encouraged the establishment of a therapeutic ritual that protected against the increase in test anxiety during the preparation phase. OLP findings were comparable, and especially the importance of a treatment rationale was stressed in both groups, counteracting an initial ambivalent attitude. The RTA findings were supported by the open-ended questions of the RCT.ConclusionIPs appear to be a well-accepted and easily applicable intervention producing a variety of beneficial effects. Thus, the IP approach might serve as an imaginary based alternative to OLPs warranting further investigations on its application to harness placebo effects without a physical pill.

Project description:CONTEXT:The prevalence of stress, burnout and mental health disorders in medical students and doctors is high. It has been proposed that there may be an association between levels of tolerance of ambiguity (ie an ability to tolerate a lack of reliable, credible or adequate information) in clinical work and psychological well-being within this population. The aims of this systematic review were: (i) to assess the nature and extent of the literature available, in order to determine if there is an association, and (ii) to develop a conceptual model proposing possible mechanisms to underpin any association, in order to inform subsequent research. METHODS:MEDLINE, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and PsycINFO databases were searched for articles published from inception to September 2018. Additional literature was identified by searching the reference lists of included articles, forward searches of included articles, hand searches of key journals and a grey literature search. Of the 671 studies identified, 11 met the inclusion criteria. A qualitative synthesis of included studies was performed. RESULTS:All 11 included studies reported an association between a lower level of tolerance of ambiguity or uncertainty and reduced psychological well-being. Included studies were heterogeneous in terms of population and measurement approach, and were often of low methodological quality. Subsets of items from previously developed scales were often used without sufficient consideration of the impact of new combinations of items on scale validity. Similar scales were also scored inconsistently between studies, making comparison difficult. CONCLUSIONS:There appears to be an association between tolerance of ambiguity and psychological well-being. This provides new opportunities to understand and prevent the development of stress, burnout and mental health disorders in medical students and doctors. The conceptual model developed provides a framework for future research, which we hope will prevent wasted research effort through duplication and promote higher methodological quality.

Dataset Information

Effects of open-label placebos on test performance and psychological well-being in healthy medical students: a randomized controlled trial.

Publications

Effects of open-label placebos on test performance and psychological well-being in healthy medical students: a randomized controlled trial.

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