Optimising treatment expectations in chronic lower back pain through observing others: a study protocol for a randomised clinical trial

IntroductionChronic lower back pain (CLBP) is a frequent cause of medical consultations worldwide, and it results in decreased quality of life and disability. Current treatments for CLBP are often not effective, and alternatives are urgently needed. Three promising possibilities have emerged: (1) open-label placebo treatment reduces chronic pain, (2) placebo treatment is as efficacious as opioid treatment with a high correlation between patient expectation and treatment outcome, and (3) observing positive effects in another patient can improve functional capacity. We hypothesise that treatment expectations can be positively influenced through social observation and improve treatment outcome.Methods and analysisIn our clinical trial, we will randomise patients with CLBP into five groups. Two groups receive either a 3 week course of treatment with an analgesic (ANA) (metamizole/dipyrone) or with open-label placebos (OLP). For one of each group, we will build treatment expectations through observational learning and assess its impact on the treatment. For this purpose, one group each will watch either a positive or a neutral video. The intervention groups will be compared with a control group that will not be given any medication or observational learning. Participants will be recruited via all institutions in the Hamburg metropolitan area that treat patients with CLBP. Patients are eligible for inclusion if they are at least 18 years or older, have CLBP (of at least 3 months duration), and agree to potentially receive an active ANA or an OLP. Patients with pain-related “red flags” will be excluded. The study requires 150 participants (30 participants per group) to assess the differences in the primary outcome, pain intensity. Secondary outcomes include changes in treatment expectations, anxiety, comorbid depression, stress-related neuroendocrine measures, functional and structural connectivity, functional capacity, and ANA consumption. All outcomes and treatment expectations will be measured before and after the intervention and 3 months post-intervention.Ethics and disseminationEthical approval was obtained in January 2020 from the Hamburg Medical Ethics Council (ref number PV7067). Outcomes will be disseminated through publications in peer-reviewed journals and presentations at national and international conference meetings.Trial registration numberThe approved trial protocol was registered at the German Clinical Trials Register (DRKS) and can be found at drks.de (Identifier: DRKS00024418).

Consequences of a Diagnostic Label: A Systematic Scoping Review and Thematic Framework

Objectives: To develop a thematic framework for the range of consequences arising from a diagnostic label from an individual, family/caregiver, healthcare professional, and community perspective.Design: Systematic scoping review of qualitative studies.Search Strategy: We searched PubMed, Embase, PsycINFO, Cochrane, and CINAHL for primary studies and syntheses of primary studies that explore the consequences of labelling non-cancer diagnoses. Reference lists of included studies were screened, and forward citation searches undertaken.Study Selection: We included peer reviewed publications describing the perceived consequences for individuals labelled with a non-cancer diagnostic label from four perspectives: that of the individual, their family/caregiver, healthcare professional and/or community members. We excluded studies using hypothetical scenarios.Data Extraction and Synthesis: Data extraction used a three-staged process: one third was used to develop a preliminary framework, the next third for framework validation, and the final third coded if thematic saturation was not achieved. Author themes and supporting quotes were extracted, and analysed from the perspective of individual, family/caregiver, healthcare professional, or community member.Results: After deduplication, searches identified 7,379 unique articles. Following screening, 146 articles, consisting of 128 primary studies and 18 reviews, were included. The developed framework consisted of five overarching themes relevant to the four perspectives: psychosocial impact (e.g., positive/negative psychological impact, social- and self-identity, stigma), support (e.g., increased, decreased, relationship changes, professional interactions), future planning (e.g., action and uncertainty), behaviour (e.g., beneficial or detrimental modifications), and treatment expectations (e.g., positive/negative experiences). Perspectives of individuals were most frequently reported.Conclusions: This review developed and validated a framework of five domains of consequences following diagnostic labelling. Further research is required to test the external validity and acceptability of the framework for individuals and their family/caregiver, healthcare professionals, and community.

Great Expectations: Recommendations for improving the methodological rigor of psychedelic clinical trials

Rationale: Psychedelic research continues to garner significant public and scientific interest with a growing number of clinical studies examining a wide range of conditions and disorders. However, expectancy effects and effective condition masking have been raised as critical limitations to the interpretability of the research.Objective: In this article, we review the many methodological challenges of conducting psychedelic clinical trials and provide recommendations for improving the rigor of future research.Results: We found that although some challenges are shared with psychotherapy and pharmacology trials more broadly, psychedelic clinical trials have to contend with several unique sources of potential bias. The subjective effects of a high-dose psychedelic are often so pronounced that it is difficult to mask participants to their treatment condition; the significant hype from positive media coverage on the clinical potential of psychedelics influences participants’ expectations for treatment benefit; and participant unmasking and treatment expectations can interact in such a way that makes psychedelic therapy highly susceptible to large placebo and nocebo effects. Specific recommendations to increase the success of masking procedures and reduce the influence of participant expectancies concern study development, participant recruitment and selection, incomplete disclosure of the study design, choice of active placebo condition, as well as the measurement of participant expectations and masking efficacy.Conclusion: Incorporating these design elements is intended to reduce the risk of bias in psychedelic clinical trials and thereby increase the ability to discern treatment-specific effects of psychedelic therapy

Expectations of treatment outcomes in patients with spinal metastases; what do we tell our patients? A qualitative study

Background Realistic pre-treatment expectations are important and have been associated with post-treatment health related quality of life (HRQOL). Patient expectations are greatly influenced by physicians, as they are the primary resource for information. This study aimed to explore the communication practices of physicians regarding treatment outcomes for patients with spinal metastases, and physician experiences with patients’ pre-treatment expectations. Methods An international qualitative study using semi-structured interviews with physicians routinely involved in treating metastatic spine disease (spine surgeons, radiation and medical oncologists, and rehabilitation specialists) was conducted. Physicians were interviewed about the content and extent of information they provide to patients with spinal metastases regarding treatment options, risks and treatment outcomes. Interviews were transcribed verbatim and analyzed using a thematic coding network. Results After 22 interviews data saturation occurred. The majority of the physicians indicated that they currently do not establish patients’ pre-treatment expectations, despite acknowledging the importance of these expectations. Spine surgeons often believe that patient expectations are disproportionate. Physicians expressed they manage expectations by detailing the most common risks and providing a broad but nonspecific overview of treatment outcomes. While the palliative intent seems clear to the physicians, their perception is that the implications of a palliative treatment remains elusive to most patients. Conclusion This study highlights the current gap in patient-physician communication regarding expectations of treatment outcomes of patients with spinal metastases. These results warrant further research to improve communication practices and determine the effect of patient expectations on patient reported outcomes in this population.

Examining Benchmarks for the Daily Report Card Intervention in a Therapeutic Recreational Setting

Objective: This study aimed to (1) examine benchmarks for the benefits of the Daily Report Card (DRC) within a therapeutic recreation setting, that is, the Summer Treatment Program (STP) and (2) explore differences in baseline characteristics and treatment outcomes among optimal and suboptimal responders. Benchmarks were examined for children’s DRC target behaviors using standardized mean difference (SMD) effect sizes (ES) across 2-week periods of the STP. Method: Participants were 38 children attending an STP. Results: Aside from teasing, all DRC targets showed improvement by the second 2-week period that was sustained through the third 2-week period. Optimal responders demonstrated greater improvement in parent-rated impairment and camp behaviors than suboptimal responders. Some baseline differences between responder groups were found. Conclusion: This study provides the first benchmarks for change in DRC targets within a therapeutic recreational setting, offering guidelines for treatment expectations. Implications for clinical decision-making, treatment planning, and future research are discussed.

The Associative Learning Prediction Error Feedback Loop as Reversible Driving Belt of the Bioenergetics of Longevity

Leukocyte telomere shortening is a useful biomarker of biological and cellular age that occurs at an accelerated rate in anxiety disorders and posttraumatic stress disorder (PTSD). Intriguingly, inhibitory learning — the systematic exposure to noxious stimuli that serves as a basis for many treatments for anxiety, phobia, and PTSD —reduces relative telomeres attrition rates and increases protective telomerase activity in a manner predictive of treatment response. How does inhibitory learning, a behavioral strategy, modulate organismal chromosomal activity? Inhibitory learning may induce repeated mismatch between treatment expectations, intrasession states, and eventual outcome. Nevertheless, inhibitory learning can incentivize repetition of the behavior. Thus, this paper aims to conceptualize inhibitory learning as involving a ‘prediction error feedback loop’, i.e., a series of self-perpetuating prediction errors — mismatches between expectations and outcomes — that enhances neural inhibitory regulation to effectuate extinction. Inhibitory learning is necessarily predicated upon an opposing process – excitatory learning – that may be conceptualized as a prediction error feedback loop that operates in reverse to inhibitory learning and enhances neural excitability as arousal. Together, excitatory and inhibitory learning may be elements of an associative learning prediction error feedback loop responsible for modulating neural bioenergetic rates, leading to changes in downstream cellular signaling that could explain reduced or increased rates of leukocyte telomere shortening and telomerase activity from each behavioral strategy, respectively.

Importance of blinding and expectations in opioid-induced constipation: evidence from a randomized controlled trial

Objectives Previous studies have found little association between objective measures and the subjective experience of opioid-induced constipation. The subjective experience of opioid-induced constipation may be influenced by treatment expectations. While most trials control for treatment expectations through blinding, success rate is generally low. This study aimed to explore the association between objective measures and the subjective experience of opioid-induced constipation, while considering blinding success and treatment expectations, and other psychological factors. Methods Data from a randomized, double-blinded, placebo-controlled crossover trial including 21 healthy male participants was analyzed. Participants received either placebo, tapentadol, or oxycodone (in equipotent doses) for 14 days. They were assessed on objective and subjective measures of opioid-induced constipation (gastrointestinal transit time and the Patient Assessment of Constipation-Symptoms questionnaire, respectively), treatment guesses to indicate blinding success, and psychological factors. Results There was a strong association between objective and subjective measures of opioid-induced constipation when participants were treated with oxycodone (r=0.676, p=0.006). Furthermore, participants were able to guess that they received active treatment when treated with oxycodone (p<0.001), suggesting that treatment expectations may have influenced the subjective experience of symptoms. Finally, patterns of moderate associations between opioid-induced constipation and other psychological factors emerged, although none reached significance (p>0.05). Conclusions Results indicate that treatment expectations could play an important role in the subjective experience of opioid-induced constipation, and support the importance of assessing blinding success in study trials. Besides expectations, other psychological factors may be associated with opioid-induced constipation.