Patients' Expectations of Yoga and Associated Therapies Influence Treatment Outcome: A Convenience Sampling Pre-Post Study from India.

An association between expectations of treatment and treatment outcome has been reported for conventional medical and surgical treatments. However, this association has not been described for yoga therapy. The present study recruited patients (154 males and 145 females, n = 299; age 48.8 ± 14.7 years) who had been admitted to a residential wellness center, most commonly with diseases of the musculoskeletal system or connective tissue; endocrine, nutritional, or metabolic diseases; and digestive system disorders (all based on ICD-11). Assessments included: (1) expectations of yoga and associated therapies at baseline using two questionnaires (Treatment Expectation Questionnaire and Expectation for Treatment Scale); and (2) treatment outcome at baseline and after 7 days of yoga and associated therapies using the Physical Health Questionnaire and Global Perceived Effect scale. The intervention included yoga and additional therapies (e.g., hydrotherapy and ayurveda for approximately 40% of the time). Multivariable regression analyses (controlled for variation due to age, gender, education, and baseline Physical Health Questionnaire scores) demonstrated that expectations of (1) positive outcomes of all aspects of treatment significantly predicted better overall perceived effect of treatment; (2) symptom resolution (positive expectations) significantly predicted higher total Physical Health Questionnaire scores, with better digestion; and (3) low adverse outcomes significantly predicted better sleep. The findings support the premise that higher positive expectations and lower negative expectations of yoga therapy predict better treatment outcomes. These findings suggest that people should be well-informed about the reported benefits and the less-frequent negative outcomes of yoga therapy so that their expectations may be positive yet realistic, optimally influencing treatment outcomes.

Patient Characteristics From Norway's First Heroin-Assisted Treatment Clinics.

BACKGROUND: Heroin-assisted treatment (HAT) is an evidence-based treatment option for opioid use disorder (OUD), available in a limited number of countries. Norway implemented a 5-year HAT project in 2022, aiming to assess its effectiveness and its potential integration into the country's OUD treatment system. This study describes and compares patients' baseline characteristics from the Oslo and Bergen HAT clinics, providing a comprehensive picture of the unique population and the real-world application of HAT. METHODS: This cross-sectional study examines the baseline characteristics of consenting HAT patients within the first 2 years of operation (n = 86). Self-reported questionnaires gathered sociodemographics, previous treatment experiences, self-reported crime, and substance use, as well as motivations and expectations for treatment. Comparisons between the clinics were carried out using t-tests, Mann-Whitney U tests, Chi-square, and Fisher's exact test. RESULTS: The majority of the patients were enrolled at the Oslo clinic (76%) and were male (80%). At admission, the average age was 45.9, with a significantly younger group in Bergen (42.5 vs 47.3, P < .05). While no patients reported being unhoused, 17% noted unstable housing within the preceding month. Unemployment was prevalent (91%) alongside previous treatment experiences (95%), with a median of 2 prior medication types. In the 3 months preceding HAT initiation, 78% of patients reported being victims of crime, and 44% committed at least one crime. Over their lifetime, 2 in 5 participants (41%) had experienced an unwanted overdose and 43% had shared syringes and equipment. CONCLUSION: This study reveals a cohort experiencing societal marginalization, including unstable housing, unsatisfactory prior OUD treatment, high-risk behaviors, and frequent interactions with criminal activities, predominantly as victims. While the Oslo and Bergen clinics serve a similar patient profile, notable differences emerged in the reasons for discontinuing past OUD treatment and crime-related factors.

Side-effect expectations are associated with disability, physical fitness, and somatic symptoms 3 months after post-COVID neurological inpatient rehabilitation.

INTRODUCTION: The COVID-19 pandemic, caused by SARS-CoV-2, has led to long-term health issues known as post-COVID-19 condition, including fatigue and cognitive disruptions. Despite its recognition as a public health concern, the efficacy of therapeutic interventions, especially in neurological rehabilitation, remains unclear. This study examines how treatment expectations are associated with psychological and physical outcomes in post-COVID-19 condition neurological rehabilitation. METHODS: In an observational cohort study 61 patients with confirmed post-COVID-19 condition were included. Baseline (T0) data on treatment and side effect expectations were collected, before participants underwent a 4-6 week multidisciplinary rehabilitation program. Primary outcome was illness-related disability (Pain Disability Index). Secondary outcomes included depressive symptoms (PHQ-9), anxiety levels (GAD-7), functional status (PCFS), fatigue (CFS), and physical fitness (6MWT). Regression models analyzed the associations of baseline expectations with outcomes at the end of rehabilitation (T1) and three months post-rehabilitation (T2). RESULTS: After adjusting for multiple testing, higher baseline side-effect expectations were associated with greater illness-related disability (ß = 0.42, p = 0.007), reduced physical fitness (ß = - 0.24, p = 0.04), and more somatic symptoms (ß = 0.33, p = 0.006) at follow-up (T2). Positive treatment expectations were associated with poorer functional status (ß = 0.35, p = 0.011) at T2. CONCLUSION: This study highlights the associations of side-effect expectations with post-COVID-19 condition rehabilitation outcomes. Higher side-effect expectations were associated to poorer outcomes, indicating a nocebo effect. Surprisingly, positive expectations were linked to worse outcomes, possibly due to unrealistic optimism. Managing patient expectations realistically and addressing side-effect concerns seems crucial for optimizing rehabilitation outcomes.

A single-item Expectancy Measure's Validity, Reliability, and Responsiveness to Detect Changes in Clinical Efficacy Studies of Integrative Cancer Therapies: A Methodology Study.

BACKGROUND: Expectations may modify outcomes. However, studies often fail to measure expectations. This raises the need for a brief valid and reliable expectancy measure. OBJECTIVES: To study treatment expectations in individuals entering acupuncture or rest, validity and test re-test reliability of a single-item expectancy measure graded on a category scale, a Numeric Rating Scale (NRS) and a Visual Analog Scale (VAS), and to identify psychometric differences between the scales. METHOD: In this methodology study, treatment expectations were measured in 363 participants before they received acupuncture (genuine traditional penetrating or non-penetrating telescopic sham acupuncture, n = 239, 98%, responded) or a control treatment involving just rest (n = 120, 100%, responded), aimed to improve level of relaxation. A treatment expectancy measure, graded on a five-grade category scale, an eight-grade NRS and a 100 mm VAS, was tested for test re-test reliability. Level of expectation and relaxation was measured at baseline, pre- and post-therapy (n = 729 expectancy measurements). RESULTS: The participants scheduled for acupuncture or rest believed moderately (Inter Quartile Range, IQR, moderately-much) and much (IQR moderately-much) the treatment to be effective. The Intra-Class Correlation coefficient versus Kappa coefficient between test and re-test was .868/.868 for the category scale, .820/.820 for the NRS, and .856/.854 for the VAS. The middle step "Believe moderately the treatment to be effective" was equivalent with median 4 (IQR, 3-4) on NRS and median 52 mm (IQR 42-52) on VAS. The response rates were 708 (97%) on the category scale, 707 (97%) on the NRS, and 703 (96%) on the VAS. All three scales discriminated that pre-therapy expectations were more positive in the individuals who reported an improvement in relaxation level (P < .001-.003). The VAS presented higher responsiveness to detect expectancy changes over time (71% increased expectation), compared to the NRS (52% increased) and the category scale (12% increased), P < .001. CONCLUSIONS: Individuals entering acupuncture, or a control intervention, presented positive treatment expectations, and the expectancy measure presented satisfactory reliability, validity, high response rates, sensitiveness, and responsiveness. Integrative cancer therapy researchers who want to control for expectancy-related bias in clinical trials should consider measuring expectation using the single-item expectancy measure.

Treatment expectations and clinical outcomes following repetitive transcranial magnetic stimulation for treatment-resistant depression.

BACKGROUND: Patient expectations, including both positive (placebo) and negative (nocebo) effects, influence treatment outcomes, yet their impact on acute repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant depression (TRD) is unclear. METHODS: In this single-center retrospective chart review, 208 TRD patients completed the Stanford Expectation of Treatment Scale (SETS) before starting open-label rTMS treatment. Patients were offered two excitatory rTMS protocols (deep TMS or intermittent theta-burst stimulation), which stimulated the left dorsolateral prefrontal cortex. A minimum of 20 once daily treatments were provided, delivered over 4-6 weeks. Primary outcomes were 1) remission, measured by a post-treatment score of <8 on the Hamilton Depression Rating Scale (HAMD-17), and 2) premature discontinuation. The change in HAMD-17 scores over time was used as a secondary outcome. Physicians were blinded to SETS scores. Logistic and linear regression, adjusting for covariates, assessed SETS and HAMD-17 relationships. RESULTS: Of 208 patients, 177 had baseline and covariate data available. The mean positivity bias score (positive expectancy minus negative expectancy subscale averages) was 0.48 ± 2.21, indicating the cohort was neutral regarding the expectations of their treatment on average. Higher positive expectancy scores were significantly associated with greater odds of remission (OR = 1.90, p = 0.003) and greater reduction in HAMD-17 scores (ß = 1.30, p = 0.005) at the end of acute treatment, after adjusting for covariates. Negative expectancy was not associated with decreased odds of remission (p = 0.2) or treatment discontinuation (p = 0.8). CONCLUSIONS: Higher pre-treatment positive expectations were associated with greater remission rates with open-label rTMS in a naturalistic cohort of patients with TRD.

The impact of patients' pre-treatment expectations on immunosuppressive treatment outcomes in myasthenia gravis: A pilot correlational study.

INTRODUCTION/AIMS: The impact of treatment expectations on active treatment outcomes has not been specifically investigated in neuromuscular disorders. We thus explored in myasthenia gravis (MG) the contribution of patients' pre-treatment expectations combined with an immunosuppressant drug on treatment outcomes. METHODS: This pilot correlational study involved 17 patients with generalized MG, scheduled to start immunosuppressant azathioprine. At baseline, a healthcare professional administered: (i) the Stanford Expectations of Treatment Scale; (ii) a structured checklist paper form asking patients which side-effects they expected to develop after starting azathioprine, coupled with a standardized framing of statements. Quantitative Myasthenia Gravis (QMG) score and daily dose of concomitant drugs were assessed by neurologists as clinical outcomes. Clinical outcomes and side-effects were re-assessed at 3 and 6 months, and clinical outcomes were monitored at 18 months. RESULTS: Clinically significant improvement in the QMG scores was achieved at 3 or 6 months. The level of state anxiety appeared to act as moderator of pre-treatment negative expectations (strong, positive, indicative correlation, rs = .733, p = .001). The latter were, in turn, associated with the fulfillment of side-effects that patients expected to develop with the new treatment (moderate, positive, indicative correlation, rs = .699, p = .002). No significant correlation emerged between positive and negative expectations. DISCUSSION: Our findings show a very quick clinical response and also suggest that patients' expectations and anxiety contributed to treatment outcomes, highlighting the importance of promoting safety messages and education strategies around newly introduced treatments. Future goals include evaluating a larger cohort that includes a matched control group.

Treatment Expectations-You Get What You Expect-and Depression Plays a Role.

Positive treatment expectations demonstrably shape treatment outcomes regarding pain and disability in patients with chronic low back pain. However, knowledge about positive and negative treatment expectations as putative predictors of interindividual variability in treatment outcomes is sparse, and the role of other psychological variables of interest, especially of depression as a known predictor of long-term disability, is lacking. We present results of the first prospective study considering expectations in concert with depression in a sample of 200 patients with chronic low back pain undergoing an inpatient interdisciplinary multimodal pain therapy. We analyzed the characteristics of pain and disability, treatment expectation, and depression assessed at the beginning (T0), at the end of (T1), and at 3-month follow-up (T2) of interdisciplinary multimodal pain therapy. Treatment expectations did emerge as a significant predictor of changes in pain intensity and disability, respectively, showing that positive expectations were associated with better treatment outcomes. Mediation analyses revealed a partially mediating effect of treatment expectations on the relation between depression and pain outcomes. PERSPECTIVE: These results expand knowledge regarding the role of treatment expectations in individual treatment outcome trajectories in chronic pain patients, paving the way for much-needed efforts toward optimizing patient expectations and personalized approaches in clinical settings.

Patient and therapist change process expectations: Independent and dyadic associations with psychotherapy outcomes.

Objective: Patients and therapists possess psychotherapy-related expectations, such as their forecast of what processes will promote improvement. Yet, there remains limited research on such change process expectations, including their independent and dyadic associations with psychotherapy outcome. In this study, we explored the predictive influence of participants' change process expectations, and their level of congruence, on therapeutic outcomes. METHODS: Patients (N = 75) and therapists (N = 17) rated their change process expectations at baseline, and patients rated their psychological distress at baseline and three months into treatment. RESULTS: Multilevel models indicated that patients' expectations for therapy to work through sharing sensitive contents openly and securely were positively related to subsequent improvement (B = -1.097; p = .007). On the other hand, patients' expectations for therapy to work through the exploration of unexpressed contents were negatively related to improvement (B = 1.388; p = .049). When patients rated the sharing of sensitive contents openly and securely higher than their therapists, they reported better outcomes (B = -16.528; p = .035). CONCLUSION: These findings suggest that patients' expectations produce diverse effects during early stages of treatment, and that patients' belief in their ability to share sensitive contents may constitute a potential target to improve therapy effectiveness.

Evaluation of Quality of Life and Treatment Satisfaction in Newly Diagnosed Cutaneous T-Cell Lymphoma Patients.

BACKGROUND: Little is known about the impact of MF on quality of life (QoL) in newly diagnosed patients. OBJECTIVES: To describe the impact of the MF diagnosis on QoL, patient expectations, and treatment satisfaction over the first 6 months after diagnosis. METHODS: Outcomes of this prospective cohort study of newly diagnosed MF patients conducted between 2020 and 2022 at the Leiden University Medical Center included the Skindex-29, RAND-12 Health Survey, degree of itch, pain, and fatigue (Visual Analogue Scale (VAS)), patient expectations, and Client Satisfaction Questionnaire-8 (CSQ-8), measured at baseline and after six months. RESULTS: A total of 28 patients with MF were included. At baseline, 66% (n = 18) "strongly-totally" expected positive effects of the treatment. At the time of diagnosis, 28% of the patients (n = 8) were moderately to severely affected. There was no statistical change in the Skindex-29 score sum score (20 [10-34] vs. 20 [9-36]; p = 0.81) or in the other three subdomains, the RAND-12 scores, and the VAS itch, pain, and fatigue over time. Treatment satisfaction was high overall. CONCLUSION: Despite that the newly diagnosed MF patients anticipate a positive treatment effect, few improvements in QoL and symptom reduction were found. These data can be used for adequate expectation management and provide a rationale for further evaluation of treatment regimens in these patients.

Parental Cognitions, Treatment Engagement, and Child Outcomes of ADHD Behavioral Treatment among Asian American Families.

Asian American (AA) families remain critically underrepresented in clinical trials for ADHD interventions. Little is known about AA families' engagement in and outcomes of behavioral treatment (BT). Comparing AA families to other minoritized (OM) families and White families, this study examined parental cognitions, treatment engagement, and child outcomes of BT for ADHD inattentive type (ADHD-I). Path analyses were conducted utilizing data from a randomized controlled trial of BT for ADHD-I (N = 199 children, ages 7-11). Racial/ethnic differences in pretreatment parental self-competence and treatment expectations were examined for AA (n = 29) compared to OM (n = 35) and White (n = 135) parents. Two additional path models were conducted to examine the relations among race/ethnicity, pretreatment parental cognitions, treatment engagement, and posttreatment child outcomes. Direct effects of race/ethnicity and parental cognitions on posttreatment child outcomes as well as their indirect effects via treatment engagement were estimated. At pretreatment, AA parents endorsed lower parental self-competence and treatment expectations compared to OM and White parents. At posttreatment, AA parents reported fewer improvements in ADHD symptoms than White parents and lower global psychosocial improvement than OM parents. For all parents, treatment expectations positively predicted parent- and observer-rated treatment engagement, which in turn predicted child global psychosocial improvement. Path analyses indicated that the relationship between treatment expectations and posttreatment child global improvement was fully mediated by treatment engagement. These findings suggest that treatment expectations impede AA parents' engagement and success in BT. Implications for cultural adaptations of BT to improve AA families' treatment experience are discussed.

Pre-treatment expectations and their influence on subjective symptom change in Crohn's disease.

BACKGROUND: Treatment expectations reportedly shape treatment outcomes, but have not been studied in the context of multimodal therapy in Crohn's disease (CD). Therefore, the current study investigated the role of treatment expectations for subjective symptom changes in CD patients who have undergone an integrative multimodal therapy program. METHODS: Validated questionnaires were completed at the start of the treatment program and post intervention. Pre-treatment expectations and experienced symptom change were assessed with the Generic Rating Scale for Previous Treatment Experiences, Treatment Expectations, and Treatment Effects (GEEE); stress levels were quantified with the Perceived Stress Scale (PSS-10) and disease specific quality of life was quantified with the disease-specific Inflammatory Bowel Disease Questionnaire (IBDQ). We performed multiple linear and Bayesian regression to determine how expectations related to symptom change. RESULTS: N = 71 CD patients (66.2% female) were included. Stronger expectations regarding symptom improvement (b = 0.422, t = 3.70, p < .001) were associated with higher experienced symptom improvement. Additionally, Bayesian analysis provided strong evidence for including improvement expectations as a predictor of improvement experience (BFinclusion = 13.78). CONCLUSIONS: In line with research in other disorders, we found that positive treatment expectations were associated with experienced symptom improvement. In contrast, we found no indication that an experience of symptom worsening was associated with positive or negative baseline treatment expectations. Induction of positive expectations might be a potential avenue for improving treatment outcomes in CD therapy.

A qualitative study to understand the Duchenne muscular dystrophy experience from the parent/patient perspective.

BACKGROUND: Duchenne muscular dystrophy (DMD) is a rare, severe, fatal neuromuscular disease characterized by progressive atrophy and muscle weakness, resulting in loss of ambulation, decreased upper body function, and impaired cardiorespiratory function. This study aimed to generate qualitative evidence to describe the primary symptoms and impacts of DMD in ambulatory and non-ambulatory patients as reported by patient/caregiver dyads. Information was also gathered on expectations for future DMD treatments. METHODS: Forty-six dyads (caregiver and patients with DMD aged 4 to 22 years) participated in 60-min semi-structured video interviews. Interview transcripts were analyzed using thematic analysis. Differences in experiences with DMD by ambulation status were examined. RESULTS: Mean ages of ambulatory (n = 28) and non-ambulatory participants (n = 18) were 8.7 and 11.3 years, respectively, with an average age of diagnosis of 3.7 years (SD = 2.3). The primary symptoms reported by both groups were lack of strength (ambulatory: n = 28, 100.0%; non-ambulatory: n = 17, 94.4%) and fatigue (ambulatory: n = 24, 85.7%; non-ambulatory: n = 14, 77.8%). Physical function was the domain that was most impacted by DMD, with participants describing progressive decline of physical function due to loss of physical strength as the primary defining feature of the disease across all stages of ambulatory ability. For those who maintained ambulatory ability at the time of the interview, physical function impacts described impaired mobility (e.g., climbing stairs: n = 16, 57.1%; running: n = 13, 46.4%), impaired upper body function, in particular fine motor skills like holding a pen/pencil or buttoning clothes (n = 17, 60.7%), problem with transfers (e.g., getting off the floor: n = 10, 35.7%), and activities of daily living (ADLs; n = 15, 53.6%). For non-ambulatory participants, the functional impacts most frequently described were problems with transfers (e.g., getting in/out of bed: n = 13, 72.2%; getting in/out of chair or position in bed: both n = 10, 55.6%), impaired upper body function (reaching: n = 14, 77.8%), and ADLs (n = 15, 83.3%). Meaningful treatment goals differed by ambulatory status; for ambulatory participants, goals included maintaining current functioning (n = 20, 71.4%), improving muscle strength (n = 7, 25.9%), and reducing fatigue (n = 6, 22.2%). For non-ambulatory participants, these included increased upper body strength (n = 8, 42.1%) and greater independence in ADLs (n = 6, 31.6%). A preliminary conceptual model was developed to illustrate the primary symptoms and physical function impacts of DMD and capture their relationship to disease progression. CONCLUSION: This study contributes to the limited qualitative literature by characterizing impacts of physical limitations and symptoms of DMD on disease progression and thus providing insights into the lived experience with DMD. Differences in treatment goals were also identified based on ambulatory status. Taken together, these findings can help inform patient-centered measurement strategies for evaluating outcomes in DMD clinical research.

Cross-Cultural Adaptation and Measurement Properties of the Expectations for Treatment Scale (ETS) for Greek-Speaking Patients.

Introduction Patients' treatment expectations are key factors influencing the health outcomes in various medical conditions. Using validated measures to capture these expectations has been strongly suggested to improve the prognosis of the health outcome and promote research investigations. The Expectations for Treatment Scale (ETS) is a well-established questionnaire designed to accurately measure treatment expectations in patients with low back pain; however, it is not available in Greek yet. We aimed to translate and cross-culturally adapt the ETS in Greek (ETS-Gr) and evaluate its reliability and validity in a Greek-speaking population with musculoskeletal disorders. Methods We followed published recommendations for the translation and cross-cultural adaptation process of the scale. Face and content validity were evaluated using interviews with patients and experts. Internal consistency, test-retest reliability, and measurement error were evaluated in 52 patients with musculoskeletal conditions. Results During forward and backward translation minor linguistic discrepancies were detected and effectively adapted for Greek-speaking patients. The ETS-Gr presented a high level of content validity (item content validity index: 0.88-1; and average scale content validity index: 0.90), acceptable internal consistency (Cronbach's alpha: 0.84), and excellent test-retest reliability (intraclass correlation coefficient: 0.96, 95% confidence interval: 0.93-0.98). Conclusions The ETS-Gr is a short, reliable, and valid instrument to measure pre-treatment expectations in patients with musculoskeletal disorders. Future investigations including other medical conditions are required.

Nocebo effects in visceral pain: concept and design of the experimental randomized-controlled pain study 'NoVis'.

The role of psychological factors in the pathophysiology and treatment of chronic visceral pain in disorders of gut-brain interactions (DGBI) is increasingly appreciated. Placebo research has underscored that expectations arising from the psychosocial treatment context and from prior experiences shape treatment responses. However, effects of negative expectations, i.e., nocebo effects, as they are likely crucial elements of DGBI patients' clinical reality, have thus far only rarely been investigated in the context of visceral pain, with untapped potential for improved prevention and treatment. The experimental randomized-controlled pain study "NoVis," carried out within the Collaborative Research Center (CRC) 289 ("Treatment Expectation"), aims to close gaps regarding the generation and persistence of nocebo effects in healthy volunteers. It is designed to elucidate effects of negative expectations in a multiple-threat paradigm with intensity-matched rectal distensions and cutaneous thermal stimuli, allowing to test nocebo effects in the visceral and somatic pain modalities. Negative expectations are experimentally induced by elements of doctor-patient communication (i.e., instruction) and/or by surreptitious amplification of symptom intensity (i.e., experience/learning) within a treatment context. Accordingly, the repeated measures between-subject design contains the between-group factors "treatment instruction" (negative vs. control) and "treatment experience" (negative vs. control), with volunteers randomized into four experimental groups undergoing several pain stimulation phases (repeated factor). This allows to compare the efficacy of instruction vs. experience, and more importantly, their combined effects on the magnitude of negative expectations and their impact on pain responses, which we expect will be greatest for the visceral modality. After a Baseline, short-term effects are assessed during a test phase accomplished on study day 1 (Test-1 Phase). To explore the persistence of effects, a second test phase is accomplished 1 week later (Test-2 Phase). Effects of negative expectations within and across pain modalities are assessed at the subjective and objective levels, with a focus on psychophysiological and neuroendocrine measures related to stress, fear, and anxiety. Since nocebo effects can play a considerable role in the generation, maintenance, or worsening of chronic visceral pain, and may even constitute risk factors for treatment failure, knowledge from experimental nocebo research has potential to improve treatment outcomes in DGBI and other clinical conditions associated with chronic visceral pain.

The role of the communicated treatment rationale on treatment outcome: study protocol for a randomized controlled trial.

BACKGROUND: Placebo effects are a well-established phenomenon in the treatment of depression. However, the mechanism underlying these effects are not fully understood. Treatment expectations are considered one explanation for why placebos work. Treatment expectations are likely to be affected by clinician-patient interactions. This study aims to investigate the role of the communicated treatment rationale in modulating treatment expectations and its effects on the treatment outcomes of a pharmacological and a psychological active placebo intervention for depression. In this study, treatment expectations are modulated by presenting illness models that are either congruent or incongruent with the treatment intervention that follows. METHODS: This 2 × 2 randomized controlled trial will involve patients with major depression. Participants will either receive a biological or a psychological illness model from a clinician. Following this, they are randomly assigned to receive either a pharmacological or a psychological active placebo intervention. The illness model and the treatment are either congruent or incongruent with each other, resulting in four groups. In addition, a natural course control group will be included. DISCUSSION: This study will provide insights into the mechanism of expectation modulation in active placebo treatments for major depression. The results may provide insights for clinicians to improve their communication with patients by focusing on treatment expectations. By identifying the factors that contribute to placebo effects, this study has the potential to improve the effectiveness of existing depression treatments and reduce the burden of this highly prevalent mental health condition. TRIAL REGISTRATION: This trial has been registered prospectively at ClinicalTrials.gov under the identifier: NCT04719663. Registered on January 22, 2021.

Concept Elicitation Interviews and Conceptual Model to Understand the Patient Experience of Limb Girdle Muscular Dystrophy.

INTRODUCTION: Limb girdle muscular dystrophies (LGMDs) are a group of rare and heterogeneous disorders involving progressive wasting of shoulder and pelvic girdle musculature. This study aimed to generate qualitative evidence on patient and caregiver experiences with symptoms and impacts of LGMD on overall function and daily life for sarcoglycanopathy subtypes 2C/R5, 2D/R3, and 2E/R4. METHODS: Twenty-three individuals with LGMD with (n = 5) or without (n = 18) a caregiver participated in 60-minute semi-structured video interviews. Interview transcripts were analyzed using thematic analysis. Differences in patient experience by ambulation status and LGMD subtype were examined. RESULTS: Participants were ambulatory (n = 14) and non-ambulatory (n = 9), representing three subtypes: 2C/R5 (n = 4), 2D/R3 (n = 12), and 2E/R4 (n = 7), with mean age of 34.8 years (SD = 16.08). 56.5% identified as female. Conceptual saturation was achieved within 18/23 interviews. Ambulatory participants identified difficulty with complex physical activities, e.g., running (n = 11, 78.6%), physical strength (n = 14, 100%), and difficulty with transfers, e.g., difficulty getting off the floor (n = 10, 71.4%). All non-ambulatory participants discussed problems with activities of daily living (ADLs) and transfers, e.g., getting in/out of bed and upper extremity function, particularly reaching (n = 8, 88.9%) and fine motor skills (n = 6, 66.7%). Fatigue and pain were reported by the majority of participants (n = 16, 69.6% and n = 19, 82.6%, respectively). A conceptual disease model was developed illustrating symptoms and impacts and their relationships to disease stage, capturing the patient experience across LGMD disease trajectory. CONCLUSIONS: This study contributes to the limited evidence describing the patient experience of living with LGMD. The conceptual model can inform patient-centered assessment in future LGMD clinical trials.

Prognostic Awareness, Palliative Care Use, and Barriers to Palliative Care in Patients Undergoing Immunotherapy or Chemo-Immunotherapy for Metastatic Lung Cancer.

Background and Objectives: This study describes patients' prognostic awareness and palliative care use in the setting of immunotherapy for metastatic non-small cell lung cancer (mNSCLC). Design: We surveyed 60 mNSCLC patients receiving immunotherapy at a large academic medical center; conducted follow-up interviews with 12 survey participants; and abstracted palliative care use, advance directive completion, and death within a year of survey completion from the medical record. Results: Forty seven percent of patients surveyed thought they would be cured; 83% were not interested in palliative care. Interviews suggested oncologists emphasized therapeutic options when discussing prognosis and that commonly used descriptions of palliative care may exacerbate misperceptions. Only 7% had received outpatient palliative care and 8% had an advance directive a year after the survey; only 16% of the 19 patients who died had received outpatient palliative care. Conclusions: Interventions are needed to facilitate prognostic discussions and outpatient palliative care during immunotherapy. Clinical Trial Registration Number NCT03741868.

Informed consent for psychotherapy: Ethical illusion or clinical reality? A survey about psychotherapists' attitudes and practices in Germany.

OBJECTIVE: This study aimed to assess clinicians' attitudes and their current clinical practices regarding informed consent for psychotherapy. METHOD: A convenience sample of N = 530 clinicians in Germany (n = 418 licensed psychotherapists and n = 112 postgraduate psychotherapy trainees) took part in an online survey. RESULTS: Most clinicians (84%) reported obtaining informed consent for psychotherapy in their daily routine. However, many psychotherapists felt unsure about satisfactorily fulfilling the legal (63%) and ethical obligations (52%). The two most frequently reported components of information disclosure related to explaining the terms and conditions of psychotherapy (96%) and the psychotherapeutic approach (91%). Providing information about mechanisms of psychotherapy (33%) and the role of expectations (30%) were least practiced. One in five psychotherapists reported not informing clients about potential risks and side effects. A considerable proportion reported concern about inducing anxiety in patients by disclosing information about risks and side effects (52%). CONCLUSIONS: Although obtaining informed consent for psychotherapy seems to be the rule rather than the exception in clinical practice, the quality of its implementation in terms of legal, ethical and clinical demands remains questionable. Training psychotherapists in providing comprehensive informed consent enables informed decision-making and might have a positive influence on treatment expectations and outcomes.

A Study of Self-Care Practice in Routine Radiotherapy Care: Identifying Differences Between Practitioners and Non-Practitioners in Sociodemographic, Clinical, Functional, and Quality-of-Life-Related Characteristics.

OBJECTIVES: The objective of this study was to describe self-care practice during radiotherapy for cancer and to identify potential differences between practitioners and non-practitioners of self-care regarding sociodemographic, clinical, functional, and quality-of-life-related characteristics. METHODS: In this descriptive study, 439 patients (87% response rate) undergoing radiotherapy responded to a study questionnaire regarding self-care, sociodemographic, clinical (eg, experienced symptoms), functional, and quality-of-life-related characteristics. RESULTS: Of the 439 patients, 189 (43%) practiced at least one self-care strategy, while 250 (57%) did not. In total, the patients described 332 self-care practices, resulting in 14 different categories of self-care strategies. The 5 most common indicators of practicing self-care were fatigue, general wellbeing, psychological symptoms, nausea, vomiting and improving physical condition. The 5 most common self-care strategies were physical activity, increased recovery, healthy eating, distraction, and skincare. Patients who were married, were older than 69, patients with less education than university education, patients undergoing a combination of internal and external radiotherapy, patients experiencing fewer than 8 symptoms, and better quality of life, practiced self-care to a lower extent than did other patients. Functional capacity did not differ between self-care practitioners and non-practitioners. CONCLUSION AND IMPLICATIONS FOR PRACTICE: Of the patients undergoing radiotherapy, slightly less than half practiced self-care during an ordinary week of radiotherapy. Because older and less-educated patients were less likely to practice self-care, cancer care practitioners should consider paying particular attention to helping such patients with their self-care practice.

Therapeutic Inertia in the Management of Psoriasis: A Quantitative Survey Among Indian Dermatologists and Patients.

Purpose: The primary objective of the study was to understand the therapeutic inertia in treatment and management of plaque psoriasis among dermatologists, along with determining the preferred treatment choices for management of plaque psoriasis; it also included the resulting treatment satisfaction among patients. The secondary objective was to identify the gaps in terms of knowledge and attitude among dermatologists and the expectations of patients. Patients and Methods: A multicentre, cross-sectional quantitative survey was conducted among dermatologists and patients with moderate to severe plaque psoriasis across India. The interviews were conducted either face to face or via telephone between September and November 2020, using structured and validated questionnaires based on specific themes. The data obtained were statistically analysed, wherever applicable. Results: Overall, 207 adult patients with moderate-to-severe plaque psoriasis and 303 dermatologists were interviewed. Post experiencing symptoms, 44% of the patients visited general physicians for treatment and there was an average 7.8-month delay by the patients to consult a dermatologist. Approximately one-fourth of patients used home remedies before seeking medical help. One-third of dermatologists used the Psoriasis Area and Severity Index (PASI) for assessing the disease severity. Majority of dermatologists preferred combination therapy for their patients. The lack of quick resolution and side effects were the major reasons for changing the treatment. Overall, only 35% of the patients complied to current treatment. Satisfaction with existing forms of therapies was highest for mild plaque psoriasis (62%) as confirmed by dermatologists, while 52% of the overall patients were satisfied with their therapy. Majority of the patients (64%) affirmed living with plaque psoriasis impacted their lives. Conclusion: This first-of-its-kind survey in India highlighted the gaps in terms of the disease journey between dermatologists and patients. The survey emphasises the need for shared decision-making and may benefit dermatologists in suggestive modifications of the treatment algorithm and disease management in clinical settings.