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Imaginary pills and open-label placebos can reduce test anxiety by means of placebo mechanisms.

ABSTRACT: Placebos have been shown to be beneficial for various conditions even if administered with full transparency. Hence, so-called open-label placebos (OLPs) offer a new way to harness placebo effects ethically. To take this concept one step further, this study aimed at evaluating placebo effects without the use of a physical placebo, i.e., by imagining taking a pill. Healthy students (N = 173) with self-reported test anxiety were either randomized to an imaginary pill (IP; n = 55), an OLP (n = 59) or a control group (CG; n = 59). Both intervention groups were instructed to take two pills daily for three weeks. Primary outcome was test anxiety, secondary outcomes were sleep quality, general well-being and test performance. Groups test anxiety differed at study-endpoint, F(2,169) = 11.50, p < .001. Test anxiety was lower in the intervention groups compared to the CG, t(169) = - 4.44, p < .001, d = - 0.71. The interventions did not differ significantly, i.e., both were similarly efficacious, t(169) = 0.61, p = .540, d = 0.11. The interaction between group and time in explaining test anxiety was significant, F(5,407.93) = 6.13, p < .001. OLPs and IPs reduced test anxiety in healthy participants compared to the CG. This finding opens the door for a novel and ethical method to harness placebo effects.

SUBMITTER: Buergler S

PROVIDER: S-EPMC9926426 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Imaginary pills and open-label placebos can reduce test anxiety by means of placebo mechanisms.

Buergler Sarah S Sezer Dilan D Bagge Niels N Kirsch Irving I Locher Cosima C Carvalho Claudia C Gaab Jens J

Scientific reports 20230214 1

Placebos have been shown to be beneficial for various conditions even if administered with full transparency. Hence, so-called open-label placebos (OLPs) offer a new way to harness placebo effects ethically. To take this concept one step further, this study aimed at evaluating placebo effects without the use of a physical placebo, i.e., by imagining taking a pill. Healthy students (N = 173) with self-reported test anxiety were either randomized to an imaginary pill (IP; n = 55), an OLP (n = 59) ...[more]

PMID: 36788309

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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:IntroductionFibromyalgia syndrome (FMS) is defined as a medical condition with chronic widespread musculoskeletal pain accompanied by mood disorders, fatigue and sleep disturbances. Treatment of this condition can often be challenging. As nutrition in general and nutritional interventions in the context of illness management become more and more important, current research also focuses on the relevance of diets for FMS, including gluten as field of interest. To date, there is no clear evidence that a gluten-free diet or other nutritional interventions are significantly important for the reduction of pain in the context of FMS. Only a very few studies show that FMS patients respond to a gluten-free diet and that cytokine production (also in FMS) can be reduced through the change. However, these studies have not investigated whether and to what extent cognitive factors, such as the expectation of symptom reduction triggered by diet, play a role. Recent research shows that treatment expectation plays an important role in the course of the disease and in the effectiveness of treatment approaches. For example, there are promising pain treatment options using open-label placebos (OLPs), which show that expectation alone, rather than the pharmacological substance of medication, can reduce pain experience. In our study protocol, we hypothesise that treatment expectation can be positively influenced by the given information regarding the placebos, resulting in improved treatment outcomes for pain and indigestions.Methods and analysisIn this trial, patients with FMS will undergo a food challenge and take an OLP (patients will be informed about the placebo), followed by a 3-week OLP treatment. The subjects will be randomised into four groups: (a) gluten-free porridge+neutral OLP instructions; (b) gluten-free porridge+positive OLP instructions; (c) gluten-containing porridge+neutral OLP instructions and (d) gluten-containing porridge+positive OLP instructions. Patients will be recruited via different institutions and support groups in Hamburg. The inclusion criteria are (a) diagnosed FMS, (b) absence of wheat allergy, coeliac disease or pain-related red flags and (c) being a minimum age of 18 years. The study requires 100 subjects to assess the primary outcomes: pain intensity and occurence of indigestion. Secondary outcomes are functional capacity, treatment expectation, and different pain-related and inflammation-related blood parameters. The measure time points will be before and after the food challenge and before and after the 3-week OLP treatment.Ethics and disseminationEthical approval was obtained in October 2021 from the Hamburg Medical Ethics Council. The results of the study will be disseminated through publications, presentations and conference meetings.Trial registration numberGerman Clinical Trials Register (DRKS; DRKS00027130).

Project description:BackgroundPlacebos can reduce physical symptoms even when provided with full honesty and disclosure. Yet, the precise mechanisms underlying the effects of "open-label placebos" (OLPs) have remained subject of debate. Furthermore, it is unclear whether OLPs are similarly effective when provided remotely, as is sometimes required e.g. in the current COVID-19 pandemic.MethodsIn a randomized-controlled trial, we examined the effects of OLP plus treatment as usual (TAU) compared to TAU alone on symptom reduction in people with allergic rhinitis (N = 54) over the course of two weeks. Due to the COVID-19 pandemic, OLP was provided remotely (i.e. sent via postal service). To investigate the potential influence of the clinical encounter on the effects of OLP, we manipulated the perception of the virtual clinical encounter, both with respect to verbal and nonverbal factors (augmented vs. limited encounter).ResultsThe results of the manipulation check confirmed that the augmented clinical encounter was evaluated more positively than the limited encounter, in terms of perceived warmth of the provider. Participants from all treatment groups showed significant symptom reduction from baseline to two weeks later, but OLP had no incremental effect over TAU. Participants benefitted more from OLP when they did not take any other medication against allergic symptoms than when taking medication on demand. When controlling for baseline symptoms, a significant treatment by encounter interaction was found, pointing to greater symptom improvement in the OLP group when the encounter was augmented, whereas the control group improved more when the encounter was limited.DiscussionThe study demonstrates that providing OLP and enhancing the encounter remotely is possible, but their effectiveness might be lower in comparison to previous studies relying on physical patient-provider interaction. The study raises questions for future research about the potential and challenges of remote placebo studies and virtual clinical encounters. The study has been registered as a clinical trial at ISRCTN (record number: 39018).

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Imaginary pills and open-label placebos can reduce test anxiety by means of placebo mechanisms.

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Imaginary pills and open-label placebos can reduce test anxiety by means of placebo mechanisms.

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