The Treatment Expectation Questionnaire (TEX-Q): Validation of a generic multidimensional scale measuring patients' treatment expectations.

BACKGROUND: Patients' expectations, as a central mechanism behind placebo and nocebo effects, are an important predictor of health outcomes. Yet, theoretically based generic assessment tools allowing for an integrated understanding of expectations across conditions and treatments are lacking. Based on the preliminary 35-item version, this study reports the development and validation of the Treatment Expectation Questionnaire (TEX-Q), a generic, multidimensional self-report scale measuring patients' expectations of medical and psychological treatments. METHODS: The TEX-Q was developed in a validation sample of n = 251 patients undergoing different treatments using exploratory factor analyses and item analyses, as well as analysis of convergent and divergent validity. Confirmatory factor analysis was conducted in an independent sample of n = 303 patients undergoing cancer treatment. Two-weeks test-retest reliability was assessed in n = 28 psychosomatic outpatients. RESULTS: Factor analyses revealed six theoretically founded stable subscales. The TEX-Q assesses expectations of treatment benefit, positive impact, adverse events, negative impact, process and behavioural control with a total of 15 items. Results for the subscales and the sum score indicated good internal consistency (α = .71-.92), moderate to high test-retest reliability (r = .39-.76) as well as good convergent validity with regard to other expectation measures (r = .42-.58) and divergent validity with regard to measures of generalized expectations (r < .32) and psychopathology (r < .28). CONCLUSIONS: While further validation is needed, the results suggest that the TEX-Q is a valid and reliable scale for the generic, multidimensional assessment of patients' treatment expectations. The TEX-Q overcomes constraints of ad-hoc and disease-specific scales, while allowing to compare the impact of different expectation constructs across conditions and treatments.

Pre-surgery optimization of patients' expectations to improve outcome in heart surgery: Study protocol of the randomized controlled multi-center PSY-HEART-II trial.

The PSY-HEART-I trial indicated that a brief expectation-focused intervention prior to heart surgery improves disability and quality of life 6 months after coronary artery bypass graft surgery (CABG). However, to investigate the clinical utility of such an intervention, a large multi-center trial is needed to generalize the results and their implications for the health care system. The PSY-HEART-II study aims to examine whether a preoperative psychological intervention targeting patients' expectations (EXPECT) can improve outcomes 6 months after CABG (with or without heart valve replacement). EXPECT will be compared to Standard of Care (SOC) and an intervention providing emotional support without targeting expectations (SUPPORT). In a 3-arm multi-center randomized, controlled, prospective trial (RCT), N = 567 patients scheduled for CABG surgery will be randomized to either SOC alone or SOC and EXPECT or SOC and SUPPORT. Patients will be randomized with a fixed unbalanced ratio of 3:3:1 (EXPECT: SUPPORT: SOC) to compare EXPECT to SOC and EXPECT to SUPPORT. Both psychological interventions consist of 2 in-person sessions (à 50 minute), 2 phone consultations (à 20 minute) during the week prior to surgery, and 1 booster phone consultation post-surgery 6 weeks later. Assessment will occur at baseline approx. 3-10 days before surgery, preoperatively the day before surgery, 4-6 days later, and 6 months after surgery. The study's primary end point will be patients' illness-related disability 6 months after surgery. Secondary outcomes will be patients' expectations, subjective illness beliefs, quality of life, length of hospital stay and blood sample parameters (eg, inflammatory parameters such as IL-6, IL-8, CRP). This large multi-center trial has the potential to corroborate and generalize the promising results of the PSY-HEART-I trial for routine care of cardiac surgery patients, and to stimulate revisions of treatment guidelines in heart surgery.

Baseline depressive symptoms, personal control, and concern moderate the effects of preoperative psychological interventions: the randomized controlled PSY-HEART trial.

This study examined whether baseline (3-14 days pre-surgery) levels of (i) depressive or (ii) anxiety symptoms and (iii) illness beliefs moderate the effects of additional preoperative interventions before coronary artery bypass graft surgery on (i) depressive or (ii) anxiety symptoms and (iii) illness beliefs 1 day before surgery, 1 week and 6 months after surgery. In the PSY-HEART trial, 115 patients were assessed. They were randomized into one of three groups: 1. receiving standard medical care only (SMC), additional psychological interventions: 2. aiming to optimize patients' expectations (EXPECT), or 3. focusing on emotional support. Patients with a higher baseline level of depressive symptoms receiving a preoperative psychological intervention indicated lower depressive symptoms 6 months after surgery compared to SMC. EXPECT increased personal control and concern levels in patients with low baseline personal control/concern 1 day before surgery. Brief preoperative psychological interventions can improve psychological outcomes in heart surgery patients. Baseline status may moderate these effects. The study has been approved by the medical ethics committee of the Philipps University of Marburg and has been pre-registered at www.clinicaltrials.gov (NCT01407055) on August 1, 2011.

IL-8 and CRP moderate the effects of preoperative psychological interventions on postoperative long-term outcomes 6 months after CABG surgery - The randomized controlled PSY-HEART trial.

INTRODUCTION: Inflammation has been related to several somatic and psychological disorders and may moderate effects of psychological interventions. In the PSY-HEART trial patients benefitted from preoperative psychological interventions before undergoing coronary artery bypass graft surgery (CABG) and, if necessary, concomitant valvular surgery, compared to standard medical care. In this study we examined whether patients' baseline inflammatory status moderated the intervention effects. MATERIAL AND METHODS: In a prospective three-arm randomized clinical trial with 6-months follow-up, 124 patients scheduled for CABG surgery alone or concomitant with valvular surgery were randomized to (i) standard medical care only (SMC) or two preoperative psychological interventions: (ii) CBT-based optimizing expectations (EXPECT) and an (iii) an active control group focusing on emotional support (SUPPORT). Available baseline CRP- (n = 79), IL-6- (n = 78), IL-8- (n = 78) and TNF-alpha-(n = 80) parameters were considered as potential moderators (CRP as a categorical and continuous moderator). Linear mixed model analyses were calculated to test whether baseline inflammatory levels moderated intervention effects on disability, mental and physical quality of life at 6 months after surgery. RESULTS: IL-8 moderated intervention effects on patients' disability and categorical CRP moderated intervention effects on mental quality of life. Follow-up tests indicated that EXPECT (and in part SUPPORT) led to lower postoperative disability and higher mental quality of life compared to SMC in patients with low baseline inflammatory markers. EXPECT indicated higher mental quality of life compared to SUPPORT in the high CRP subgroup. Patients in the SMC group had higher mental quality of life in the high CRP subgroup compared to the low CRP subgroup. CONCLUSION: Especially for patients with a lower inflammatory baseline status preoperative psychological interventions might be helpful to optimize long-term CABG surgery outcomes.

Optimizing Expectations About Endocrine Treatment for Breast Cancer: Results of the Randomized Controlled PSY-BREAST Trial.

Background: Medication side effects are strongly determined by non-pharmacological, nocebo mechanisms, particularly patients' expectations. Optimizing expectations could minimize side effect burden. This study evaluated whether brief psychological expectation management training (EXPECT) optimizes medication-related expectations in women starting adjuvant endocrine therapy (AET) for breast cancer. Method: In a multisite randomized controlled design, 197 women were randomized to EXPECT, supportive therapy (SUPPORT), or treatment as usual (TAU). The three-session cognitive-behavioral EXPECT employs psychoeducation, guided imagery, and side effect management training. Outcomes were necessity-concern beliefs about AET, expected side effects, expected coping ability, treatment control expectations, and adherence intention. Results: Both interventions were well accepted and feasible. Patients' necessity-concern beliefs were optimized in EXPECT compared to both TAU and SUPPORT, d = .41, p < .001; d = .40, p < .001. Expected coping ability and treatment control expectations were optimized compared to TAU, d = .35, p = .02; d = .42, p < 001, but not to SUPPORT. Adherence intention was optimized compared to SUPPORT, d = .29, p = .02, but not to TAU. Expected side effects did not change significantly. Conclusion: Expectation management effectively and partly specifically (compared to SUPPORT) modified medication-related expectations in women starting AET. Given the influence of expectations on long-term treatment outcome, psychological interventions like EXPECT might provide potential pathways to reduce side effect burden and improve quality of life during medication intake.

Predicting patient reassurance after colonoscopy: The role of illness beliefs.

OBJECTIVE: Failure to effectively reassure patients can lead to patients becoming distressed and seeking further medical care. Whilst existing studies have identified that patients' psychological and demographic characteristics can impact patient reassurance, little research has explored specific predictors of patient reassurance following a colonoscopy. This study investigates demographic and psychological predictors of patient reassurance after receiving normal test results following a colonoscopy. METHODS: Eighty-five participants receiving colonoscopies due to gastrointestinal symptoms were recruited from two endoscopy clinics. Patients provided demographic information and completed questionnaires assessing illness perceptions, health-related anxiety, hypochondriasis, somatisation and state and trait anxiety prior to the colonoscopy, as well as reassurance the day after the colonoscopy. Seventy-three participants provided complete data and were included in the analyses. Pearson's correlations and hierarchical linear regression were conducted to examine the associations between the baseline variables and patient reassurance after the colonoscopy. RESULTS: Health-related anxiety, hypochondriasis and four items from the Brief Illness Perceptions Questionnaire (consequence, identity, concern, and emotional response beliefs) were negatively correlated with reassurance (r's ranged from -0.28 to -0.54, P < .05). The hierarchical linear regression demonstrated that in the fully adjusted model, only consequence beliefs (i.e. negative beliefs regarding the impact of gastrointestinal symptoms) remained a robust predictor of reassurance (ß = -0.56, P = .005). CONCLUSION: This study extends existing research on patient reassurance and is the first study to demonstrate that illness beliefs predicted reassurance following a colonoscopy. These findings suggest that targeting consequence beliefs may be a useful intervention for improving patient reassurance following clinical investigations.

Effects of Preoperative Psychological Interventions on Catecholamine and Cortisol Levels After Surgery in Coronary Artery Bypass Graft Patients: The Randomized Controlled PSY-HEART Trial.

OBJECTIVE: The aim of the study was to examine whether preoperative psychological interventions targeting patients' expectations are capable of influencing the biological stress response after coronary artery bypass graft (CABG) surgery and could thus improve recovery after heart surgery. METHODS: Randomized controlled trial with assessments 10 days before surgery, after psychological intervention (day of hospital admission, but before surgery), postoperative (6-8 days later), and at follow-up (6 months after surgery). Eligible patients (N = 124) scheduled for elective on-pump CABG or CABG with valve replacement surgery were approached before hospital admission. Standard medical care (SMC) was compared with two additional preoperative psychological interventions: (a) an expectation manipulation intervention to optimize patients' expectations about course and outcomes or (b) supportive therapy, containing the same amount of therapeutic attention, but without specifically focusing on expectations. Postoperative plasma adrenaline, noradrenaline, and cortisol levels were a secondary outcome of our study (primary outcome patients' disability 6 months after surgery and other secondary patient-reported or clinical outcomes were reported elsewhere). RESULTS: Expectation manipulation intervention (3.68 ln pg/mL, 95% confidence interval = 3.38-3.98, p = .015) and supportive therapy (3.70 ln pg/mL, 95% confidence interval = 3.38-4.01, p = .026) led to significantly lower postoperative adrenaline levels compared with SMC (4.26 ln pg/mL, 95% confidence interval = 3.99-4.53) only. There were no treatment effects of the preoperative intervention for noradrenaline (p = .90) or cortisol (p = .30). Higher postoperative adrenaline levels predicted disability 6 months after surgery (r = .258, p = .018). CONCLUSIONS: In addition to SMC, preoperative psychological interventions seem to buffer psychobiological stress responses and could thus facilitate recovery from CABG surgery. Patients' postoperative stress responses could be an important factor for explaining trajectories of long-term outcomes. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov(NCT01407055).

Optimizing preoperative expectations leads to a shorter length of hospital stay in CABG patients: Further results of the randomized controlled PSY-HEART trial.

OBJECTIVE: To examine the effect of a preoperative expectation-optimizing psychological intervention on length of stay in the hospital and time spent in the Intensive Care Unit (ICU) in patients undergoing elective cardiac surgery. METHODS: In a randomized controlled trial, 124 patients prior to undergoing coronary artery bypass grafting (CABG) or CABG combined with heart valve surgery were randomized to either a) standard medical care alone (SMC) or an additional preoperative intervention, b) an additional expectation manipulation intervention (EXPECT) to optimize patients' expectations, or c) an additional supportive therapy (SUPPORT), containing the same amount of therapeutic attention but without a specific focus. Participants were followed-up post-operatively to assess their length of hospital stay and the time spent in the ICU. RESULTS: Patients in both psychological intervention groups spent significantly less days in the hospital then patients in the SMC group (M(EXPECT)=12.62, M(SUPPORT)=14.13, M(SMC)=17.27, p=0.028). There was a significant linear trend (F(1112)=7.68, p=0.009) showing that the more specific the intervention patients received the shorter they stayed in the hospital. The effect of the intervention on time spent in the ICU was only marginally significant (M(EXPECT)=103.76, M(SUPPORT)=103.10, M(SMC)=158.45, p=0.066). CONCLUSION: Changing patients' preoperative expectations via a psychological intervention leads to less days spent in the hospital. The psychological interventions are associated with positive cost-benefit ratios. Specific psychological mechanisms underlying the effect of our intervention remain unclear and need to be investigated further. TRIAL REGISTRATION: www.clinicaltrials.gov (NCT01407055).

Preoperative optimization of patient expectations improves long-term outcome in heart surgery patients: results of the randomized controlled PSY-HEART trial.

BACKGROUND: Placebo effects contribute substantially to outcome in most fields of medicine. While clinical trials typically try to control or minimize these effects, the potential of placebo mechanisms to improve outcome is rarely used. Patient expectations about treatment efficacy and outcome are major mechanisms that contribute to these placebo effects. We aimed to optimize these expectations to improve outcome in patients undergoing coronary artery bypass graft (CABG) surgery. METHODS: In a prospective three-arm randomized clinical trial with a 6 month follow-up, 124 patients scheduled for CABG surgery were randomized to either a brief psychological pre-surgery intervention to optimize outcome expectations (EXPECT); or a psychological control intervention focusing on emotional support and general advice, but not on expectations (SUPPORT); or to standard medical care (SMC). Interventions were kept brief to be feasible with a heart surgery environment; "dose" of therapy was identical for both pre-surgery interventions. Primary outcome was disability 6 months after surgery. Secondary outcomes comprised further clinical and immunological variables. RESULTS: Patients in the EXPECT group showed significantly larger improvements in disability (-12.6; -17.6 to -7.5) than the SMC group (-1.9; -6.6 to +2.7); patients in the SUPPORT group (-6.7; -11.8 to 1.7) did not differ from the SMC group. Comparing follow-up scores and controlling for baseline scores of EXPECT versus SUPPORT on the variable disability only revealed a trend in favor of the EXPECT group (P = 0.09). Specific advantages for EXPECT compared to SUPPORT were found for mental quality of life and fitness for work (hours per week). Both psychological pre-surgery interventions induced less pronounced increases in pro-inflammatory cytokine concentrations reflected by decreased interleukin-8 levels post-surgery compared to changes in SMC patients and lower interleukin-6 levels in patients of the EXPECT group at follow-up. Both pre-surgery interventions were characterized by great patient acceptability and no adverse effects were attributed to them. Considering the innovative nature of this approach, replication in larger, multicenter trials is needed. CONCLUSIONS: Optimizing patients' expectations pre-surgery helps to improve outcome 6 months after treatment. This implies that making use of placebo mechanisms has the potential to improve long-term outcome of highly invasive medical interventions. Further studies are warranted to generalize this approach to other fields of medicine. TRIAL REGISTRATION: Ethical approval for the study was obtained from the IRB of the Medical School, University of Marburg, and the trial was registered at ( NCT01407055 ) on July 25, 2011.

What do women with breast cancer expect from their treatment? Correlates of negative treatment expectations about endocrine therapy.

OBJECTIVES: Patients' negative treatment expectations can lead to nocebo-related side effects and non-initiation of treatment. This study aims to identify correlates of treatment expectations in patients with breast cancer before the start of endocrine therapy. METHODS: Expectations were assessed in a cross-sectional sample of 166 patients with breast cancer after receiving treatment information. Side effect expectations (one item) and treatment necessity-concern balance (Beliefs about Medicines Questionnaire) were assessed. Correlates were analyzed using regression analyses. The structure of treatment expectations was investigated using a network analysis. RESULTS: About 25% of patients expressed negative expectations. Higher side effect expectations were associated with lower treatment efficacy expectations (ß = -0.20, p = 0.01), higher medication overuse beliefs (ß = 0.17, p = 0.01), and a negative treatment appraisal before study treatment information (ß = -0.17, p = 0.02). A negative necessity-concern balance was associated with lower treatment efficacy expectations (ß = 0.36, p < 0.001), lower adherence intention (ß = 0.21, p < 0.001), and no knowledge of tumor's receptor status (ß = 0.21, p < 0.001); furthermore, it was associated with higher medication harmfulness beliefs (ß = -0.16, p = 0.02), negative treatment pre-appraisal (ß = 0.15, p = 0.01), higher somatosensory amplification (ß = -0.14, p = 0.02), and higher education (ß = -0.12, p = 0.02). The most important network node was the concern that endocrine therapy disrupts life. CONCLUSION: Negative treatment expectations before treatment start are mainly associated with psychological variables. These results are relevant for patient education in clinical settings. To improve expectations, clinicians might emphasize treatment efficacy and discuss general and specific medication concerns. Improving treatment knowledge could also be beneficial. Copyright © 2016 John Wiley & Sons, Ltd.

Optimizing preoperative expectations in cardiac surgery patients is moderated by level of disability: the successful development of a brief psychological intervention.

Patients' expectations have shown to be a major psychological predictor of health outcome in cardiac surgery patients. However, it is unclear whether patients' expectations can be optimized prior to surgery. This study evaluates the development of a brief psychological intervention focusing on the optimization of expectations and its effect on change in patients' expectations prior to cardiac surgery. Ninety patients scheduled for coronary artery bypass graft were randomly assigned to (1) standard medical care, (2) additional expectation manipulation intervention (EMI), and (3) additional attention control group. Therapists' fidelity to intervention manuals and patients satisfaction with the intervention were assessed for both active intervention conditions. Patients' expectations about post-surgical disability, treatment control, personal control, and disease duration were assessed before and after the psychological intervention. Demographical, medical, and psychosocial characteristics and disability were assessed at baseline. Treatment fidelity and patient satisfaction was very high in both intervention conditions. Only patients receiving EMI developed higher personal control expectations and longer (more realistic) expectations of disease duration. The effect of intervention group on patients' disability expectations and patients' personal control expectations was moderated by patient's level of disability. EMI patients with low to moderate disability developed positive expectations whereas patients with high disability did not. This study shows the successful development of a short psychological intervention that was able to modify patients' expectations, especially in those with low to moderate disability. Given the robust association of expectations and surgery outcome, such an intervention might offer the opportunity to enhance patients' health following cardiac surgery.

Framing and personalizing informed consent to prevent negative expectations: An experimental pilot study.

OBJECTIVE: Informing patients about medical treatments and their possible side effects is ethically and legally obligatory but may trigger negative expectations and nocebo-related side effects. This pilot study aims to investigate the effect of different informed consent procedures on treatment expectations for adjuvant breast cancer treatments (Study 1: endocrine therapy; Study 2: chemotherapy). METHOD: Using an experimental 2-factorial design, healthy women were informed about endocrine therapy (n = 60) or chemotherapy (n = 64) within a hypothetical scenario. Information was framed with or without treatment benefit information and delivered in a personalized or standardized interaction. Primary outcomes were necessity-concern beliefs about the treatment and side-effect expectations, secondary outcomes were decisional conflicts. RESULTS: In Study 1, side-effect expectations (η²p= .08) and decisional conflicts (η²p = .07) were lower when framed treatment information was given. Providing personalized information resulted in more functional necessity-concern beliefs (η²p = .06) and lower decisional conflicts (η²p = .07). Personalizing and framing of information resulted in more functional necessity-concern beliefs (η²p = .10) and lower decisional conflicts. In Study 2, necessity-concern beliefs were more functional with framing (η²p = .06). Participants in the personalized groups reported lower decisional conflicts (η²p = .06). No differences in side-effect expectations were revealed. CONCLUSIONS: This is the first study to provide evidence for optimized treatment expectations through altered informed consent strategies. The results emphasize that framing and personalizing informed consent can positively influence treatment expectations and reduce decisional conflicts. However, generalizations are impaired by the study's pilot character. The potential to prevent nocebo responses in clinical practice should be analyzed. (PsycINFO Database Record

Informing women with breast cancer about endocrine therapy: effects on knowledge and adherence.

OBJECTIVE: Adherence to adjuvant endocrine therapy in women with breast cancer is low, and patients are not informed sufficiently. This study analyzes the effects of a structured treatment information on patients' satisfaction, knowledge, and adherence. METHODS: An interventional single cohort study of postoperative women with estrogen-receptor-positive breast cancer was conducted to study the effects of enhanced information about endocrine therapy given additionally to clinical routine information. Knowledge and satisfaction with additional information given 1-3 weeks after surgery were assessed before and after informing patients; adherence and knowledge were measured 3 months after start of treatment. RESULTS: A total of 137 patients were analyzed before and after provision of enhanced treatment information as well as 3 months after start of endocrine therapy. Enhanced information increased satisfaction with information and knowledge. The percentage of patients who knew their estrogen receptor status increased from 50% to 93%. At 3 months follow-up, 60% still had correct knowledge. Patients who learned their receptor status were older, and those who forgot had lower cognitive abilities and lower educational level. Patients with higher satisfaction, better learning, and comprehension directly after enhanced information showed better adherence at 3 months follow-up. CONCLUSION: Patients, especially older ones, can benefit from enhanced treatment information given additionally to routine care. Enhanced information about mode of action and potential side effects of endocrine therapy when included into clinical routine might foster patient autonomy and prevent early disruptions in adherence.

Factors associated with disability expectations in patients undergoing heart surgery.

BACKGROUND: Heart surgery patients' expectations have been shown to be related to surgery outcome, independent of medical status. However, it is unclear which factors determine patients' expectations about disability following heart surgery. PURPOSE: Investigating the associations of patients' disability expectations with demographic, medical, and psychosocial factors as well as other aspects of patients' expectations might help to tailor psychological interventions more specifically to optimize patient's expectations. METHODS: Eighty-three patients were invited to a psycho-educational intervention to optimize expectations prior to elective coronary artery bypass graft (CABG). Before the psychological intervention and before surgery, disability expectations, demographical, medical, psychosocial variables as well as patient and treatment related expectations were collected via questionnaires and patients' files. Associations with disability expectations were assessed using hierarchical linear multiple regression analysis. RESULTS: Patients self-rated disability (ß = 0.50; p < 0.001) and beliefs about treatment efficacy (ß = -0.42; p < 0.001) was independently associated with disability expectations. Expectations about the efficacy of patients' own health behavior as well as demographical variables, psychological distress, perceived social support, and measures of medical morbidity did not explain any additional variance in patients' disability expectations. CONCLUSION: CABG patients seem to form their disability expectations upon their perceptions about their current disability and their expectations about the efficacy of treatment. Patients' disability expectations appear to be independent from scientifically established risk factors and other psychosocial patient characteristics in heart surgery. Future research is necessary to further determine what factors psychological interventions should focus on to modify patients' disability expectations.