Open notes in psychotherapy: An exploratory mixed methods survey of psychotherapy students in Switzerland.

Background: In a growing number of countries, patients are offered access to their full online clinical records, including the narrative reports written by clinicians (the latter, referred to as "open notes"). Even in countries with mature patient online record access, access to psychotherapy notes is not mandatory. To date, no research has explored the views of psychotherapy trainees about open notes. Objective: This study aimed to explore the opinions of psychotherapy trainees in Switzerland about patients' access to psychotherapists' free-text summaries. Methods: We administered a web-based mixed methods survey to 201 psychotherapy trainees to explore their familiarity with and opinions about the impact on patients and psychotherapy practice of offering patients online access to their psychotherapy notes. Descriptive statistics were used to analyze the 42-item survey, and qualitative descriptive analysis was employed to examine written responses to four open-ended questions. Results: Seventy-two (35.8%) trainees completed the survey. Quantitative results revealed mixed views about open notes. 75% agreed that, in general open notes were a good idea, and 94.1% agreed that education about open notes should be part of psychotherapy training. When considering impact on patients and psychotherapy, four themes emerged: (a) negative impact on therapy; (b) positive impact on therapy; (c) impact on patients; and (d) documentation. Students identified concerns related to increase in workload, harm to the psychotherapeutic relationship, and compromised quality of records. They also identified many potential benefits including better patient communication and informed consent processes. In describing impact on different therapy types, students believed that open notes might have differential impact depending on the psychotherapy approaches. Conclusions: Sharing psychotherapy notes is not routine but is likely to expand. This mixed methods study provides timely insights into the views of psychotherapy trainees regarding the impact of open notes on patient care and psychotherapy practice.

A qualitative study of imaginary pills and open-label placebos in test anxiety.

BACKGROUND: The 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. METHODS: A 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. RESULTS: Four 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. CONCLUSION: IPs 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.

The roles of expectation, comparator, administration route, and population in open-label placebo effects: a network meta-analysis.

Three meta-analyses have demonstrated the clinical potential of open-label placebos (OLPs). However, there is a need to synthesize the existing evidence through more complex analyses that would make it possible to answer questions beyond mere efficacy. Such analyses would serve to improve the understanding of why and under what circumstances OLPs work (e.g., depending on induced expectations or across different control groups). To answer these questions, we conducted the first network meta-analyses in the field of OLPs. Our analyses revealed that OLPs could be beneficial in comparison to no treatment in nonclinical (12 trials; 1015 participants) and clinical populations (25 trials; 2006 participants). Positive treatment expectations were found to be important for OLPs to work. Also, OLP effects can vary depending on the comparator used. While the kind of administration route had no substantial impact on the OLP effects, effects were found to be larger in clinical populations than in nonclinical populations. These results suggest that the expectation, comparator, administration route, and population should be considered when designing and interpreting OLP studies.

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

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.

Greater than the sum of the parts: a qualitative content analysis of what constitutes a good treatment in the inpatient setting.

BACKGROUND: The evaluation of psychotherapy is guided by established concepts, such as efficacy and effectiveness, and acceptability. Although these concepts serve as valid proxies, little is known about corresponding criteria for those directly involved in this treatment. This study aimed to explore inpatients' and health professionals' definitions of a good treatment in the inpatient setting. METHODS: Fifteen semi-structured interviews were conducted in a private psychiatric clinic in Switzerland and structured by qualitative content analysis. Different subsamples of the inpatient setting (patients N = 5; psychiatrists N = 5; other health professionals N = 5) were interviewed. RESULTS: In total, 546 text passages were grouped in 10 superordinate categories and identified as relevant for the concept of a good treatment. Participants stressed patient-specific (i.e., new insights; basic attitudes), treatment-specific (i.e., therapy methods and expertise; treatment success; therapy setting), and relationship-based (i.e., communication and feedback; relationships within the clinical setting; overcoming challenges and hurdles) components that are indispensable for a good therapeutic process. Components that are related to the clinical inpatient setting (i.e., setting and organization of the clinic; code of conduct) were also highlighted. CONCLUSIONS: Patients' and health professionals' definitions of what constitutes a good treatment entails a wide array of aspects. The clinical setting is seen to offer unique components that are emphasized to have a healing effect.

Open-Label Placebo Treatment for Acute Postoperative Pain (OLP-POP Study): Study Protocol of a Randomized Controlled Trial.

Introduction: Open-label placebos have been proposed as way of using long recognized analgesic placebo effects in an ethical manner. Recent evidence shows efficacy of open-label placebos for clinical conditions, but there is need for more research on open-label placebos in acute pain. In the treatment of acute postoperative pain, minimization of opioid related side effects remains one of the key challenges. Therefore, this study aims at investigating the potential of adding unconditioned open-label placebos to treatment as usual as a means of reducing opioid consumption and its related side effects in patients with acute postoperative pain. Methods and Analysis: This is the protocol of an ongoing single site randomized controlled trial. The first patient was enrolled in May 2020. In total, 70 patients suffering from acute postoperative pain following dorsal lumbar interbody fusion are randomized to either a treatment as usual group or an experimental intervention group. The treatment as usual group consists of participants receiving a patient-controlled morphine pump. On day 1 and 2 post-surgery, patients in the intervention group receive, in addition to treatment as usual, two open-label placebo injections per day along with an evidence-based treatment rationale explaining the mechanisms of placebos. The primary outcome is measured by means of self-administered morphine during day 1 and 2 post-surgery. Several other outcome measures including pain intensity and adverse events as well as potential predictors of placebo response are assessed. Analysis of covariance will be used to answer the primary research question and additional statistical techniques such as generalized linear mixed models will be applied to model the temporal course of morphine consumption. Discussion: This study will provide valuable insights into the efficacy of open-label placebos in acute pain and will potentially constitute an important step toward the implementation of open-label placebos in the clinical management of acute postoperative pain. In addition, it will shed light on a cost-efficient and patient-centered strategy to reduce opioid consumption and its related side effects, without any loss in pain management efficacy. Ethics and Dissemination: The "Ethikkommission Nordwest- und Zentralschweiz" (BASEC2020-00099) approved the study protocol. Results of the analysis will be submitted for publication in a peer-reviewed journal. Clinical Trial Registration: The study is registered at ClinicalTrials.gov (NCT04339023) and is listed in the Swiss national registry at kofam.ch (SNCTP000003720).

Lay perspectives of the open-label placebo rationale: a qualitative study of participants in an experimental trial.

OBJECTIVES: To analyse participants' concepts about the open-label placebo (OLP) effect; to explore their views about the discussion points that are applied in conventional OLP trials and to examine their experiences of taking part in an OLP trial. DESIGN: A qualitative study using thematic analysis of semistructured interviews that were nested within a randomised controlled trial investigating experimental OLP analgesia (registered at ClinicalTrials.gov: NCT02578420). PARTICIPANTS: 30 healthy adults who took part in the randomised controlled trial. RESULTS: Participants mostly conceptualised placebo as something that is inert and requires deception in order to be effective. Interviewees used a broad definition of placebos, going beyond a conventional notion of sugar pills. In contrast to the conventional OLP rationale, participants seldom emphasised classical conditioning as a mechanism of placebo effects, stressing a variety of other well-established components through which placebos might be therapeutic, whereas the conventional OLP disclosures state that 'a positive attitude helps but is not necessary', participants in our study applied other attitudes, such as 'it's worth a try'. When asked about their experiences during the trial, the majority emphasised that the concept of OLP was completely novel to them. Participants were rather sceptical about the efficacy of the intervention. CONCLUSION: Integrating lay perspectives into the scientific rationale of OLP treatments might enhance the plausibility and credibility of the rationale in ethical treatments. TRIAL REGISTRATION NUMBER: NCT02578420.

Putting the 'Art' Into the 'Art of Medicine': The Under-Explored Role of Artifacts in Placebo Studies.

Research in social psychology demonstrates that physical environmental factors - or "artifacts" such as provider clothing and office décor - can influence health outcomes. However, the role of artifacts in augmenting or diminishing health outcomes is under-explored in the burgeoning discipline of placebo studies. In this paper, we argue that a careful consideration of artifacts may carry significant potential in informing how placebo effects can be maximized, and nocebo effects minimized in clinical settings. We discuss the potential mechanisms, including classical conditioning, response expectancy, and mindsets, by which artifacts might enhance or diminish these effects. Next, we propose testable hypotheses to investigate how placebo and nocebo effects might be elicited by artifacts in care settings, and conclude by providing innovative research designs to advance this novel research agendum.

Primary care providers' use of and attitudes towards placebos: An exploratory focus group study with US physicians.

OBJECTIVE: To examine how primary care physicians define placebo concepts, use placebos in clinical practice, and view open-label placebos (OLPs). DESIGN: Semi-structured focus groups that were audio-recorded and content-coded. METHODS: Two focus groups with a total of 15 primary care physicians occurred at medical centres in the New England region of the United States. Prior experience using placebo treatments and attitudes towards open-label placebos were explored. Themes were analysed using an inductive data-driven approach. RESULTS: Physicians displayed a nuanced understanding of placebos and placebo effects in clinical contexts which sometimes focused on relational factors. Some respondents reported that they prescribed treatments with no known pharmacological effect for certain conditions and symptoms ('impure placebos') and that such prescriptions were more common for pain disorders, functional disorders, and medically unexplained symptoms. Opinions about OLP were mixed: Some viewed OLPs favourably or considered them 'harmless'; however, others strongly rejected OLPs as disrespectful to patients. Other issues in relation to OLPs included the following: lack of guidelines, legal and reputational concerns, and the notion that such treatments would run counter to customary medical practice. CONCLUSIONS: A number of physicians reported prescribing impure placebos in clinical care. Although some primary care physicians were resistant to the possibility of recommending OLPs, others regarded OLPs more favourably, viewing them as potential treatments, albeit with restricted potential. Statement of contribution What is already known? Many physicians report prescribing drugs for the purposes of eliciting a placebo effect. Initial evidence for the efficacy of open-label placebos is promising. What does this study add? A more nuanced description of the circumstances under which primary care physicians report placebo prescribing. A qualitative account of physician attitudes about using open-label placebos in clinical practice.

The Healing Encounters and Attitudes Lists (HEAL): Psychometric Properties of a German Version (HEAL-D) in Comparison With the Original HEAL.

Introduction: Over the last years, the interest in understanding health improvements that occur due to non-specific treatment effects, rather than in response to the specific active treatment ingredients, increased. Nevertheless, investigations on patients' idiosyncratic perspectives on the non-specific aspects of the healing encounter or of the treatment itself that contribute to placebo effects are still rare. The Healing Encounters and Attitudes Lists (HEAL) offer a unique and parsimonious set of instruments to measure patients' views on a variety of non-specific aspects of the caring encounter. The HEAL items can be administered as computerized adaptive tests or short forms that assess the patient-provider connection, the healthcare environment, treatment expectancy, positive outlook, spirituality, as well as attitudes towards complementary and alternative medicine. So far, no German version of the HEAL exists. Methods: The original 168 HEAL items were translated into German (HEAL-D) applying a translation-back-translation procedure. We examined the psychometric properties of HEAL-D in a sample of 165 participants who reported at least one healthcare visit during the last year. Results: The German short forms of HEAL (HEAL-D-SF) showed good internal consistency and test-retest reliability. The factor structure observed in the English original items showed low to moderate model fit in our sample. Discussion: The development of a German version of HEAL in addition to the original English items offers new possibilities for investigating patients' idiosyncratic perspectives on the non-specific aspects of treatments across language borders. We will close with presenting possible clinical application as well as promising and relevant future research directions using HEAL-D-SF, including for instance large-scale, cross-national investigations.