Little is known about clinically relevant changes in guided Internet-based interventions for depression. Moreover, methodological and power limitations preclude the identification of patients' groups that may benefit more from these interventions. This study aimed to investigate response rates, remission rates, and their moderators in randomized controlled trials (RCTs) comparing the effect of guided Internet-based interventions for adult depression to control groups using an individual patient data meta-analysis approach. Literature searches in PubMed, Embase, PsycINFO and Cochrane Library resulted in 13,384 abstracts from database inception to January 1, 2016. Twenty-four RCTs (4889 participants) comparing a guided Internet-based intervention with a control group contributed data to the analysis. Missing data were multiply imputed. To examine treatment outcome on response and remission, mixed-effects models with participants nested within studies were used. Response and remission rates were calculated using the Reliable Change Index. The intervention group obtained significantly higher response rates (OR = 2.49, 95% CI 2.17-2.85) and remission rates compared to controls (OR = 2.41, 95% CI 2.07-2.79). The moderator analysis indicated that older participants (OR = 1.01) and native-born participants (1.66) were more likely to respond to treatment compared to younger participants and ethnic minorities respectively. Age (OR = 1.01) and ethnicity (1.73) also moderated the effects of treatment on remission.Moreover, adults with more severe depressive symptoms at baseline were more likely to remit after receiving internet-based treatment (OR = 1.19). Guided Internet-based interventions lead to substantial positive treatment effects on treatment response and remission at post-treatment. Thus, such interventions may complement existing services for depression and potentially reduce the gap between the need and provision of evidence-based treatments.
Patients’ expectations in the context of medical treatment represent a growing area of research, with accumulating evidence suggesting their influence on health outcomes across a variety of medical conditions. However, the aggregation of evidence is complicated due to an inconsistent and disintegrated application of expectation constructs and the heterogeneity of assessment strategies. Therefore, based on current expectation concepts, this critical review provides an integrated model of patients’ expectations in medical treatment. Moreover, we review existing assessment tools in the context of the integrative model of expectations and provide recommendations for improving future assessment. The integrative model includes expectations regarding treatment and patients’ treatment-related behavior. Treatment and behavior outcome expectations can relate to aspects regarding benefits and side effects and can refer to internal (e.g., symptoms) and external outcomes (e.g., reactions of others). Furthermore, timeline, structural and process expectations are important aspects with respect to medical treatment. Additionally, generalized expectations such as generalized self-efficacy or optimism have to be considered. Several instruments assessing different aspects of expectations in medical treatment can be found in the literature. However, many were developed without conceptual standardization and psychometric evaluation. Moreover, they merely assess single aspects of expectations, thus impeding the integration of evidence regarding the differential aspects of expectations. As many instruments assess treatment-specific expectations, they are not comparable between different conditions. To generate a more comprehensive understanding of expectation effects in medical treatments, we recommend that future research should apply standardized, psychometrically evaluated measures, assessing multidimensional aspects of patients’ expectations that are applicable across various medical treatments. In the future, more research is needed on the interrelation of different expectation concepts as well as on factors influencing patients’ expectations of illness and treatment. Considering the importance of patients’ expectations for health outcomes across many medical conditions, an integrated understanding and assessment of such expectations might facilitate interventions aiming to optimize patients’ expectations in order to improve health outcomes.
BackgroundPlacebo 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.MethodsIn 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.ResultsPatients 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.ConclusionsOptimizing 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 registrationEthical 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.Electronic supplementary materialThe online version of this article (doi:10.1186/s12916-016-0767-3) contains supplementary material, which is available to authorized users.
This study provides evidence for the efficacy of an unguided, Internet-based occupational recovery training and provided first evidence for a number of assumed mechanisms of change.
These results confirm the importance of patients' expectations in the prediction of postsurgical outcomes and underline the necessity to optimize these expectations in order to improve postoperative quality of life.
Background Almost nothing is known about the potential negative effects of Internet-based psychological treatments for depression. This study aims at investigating deterioration and its moderators within randomized trials on Internet-based guided self-help for adult depression, using an individual patient data meta-analyses (IPDMA) approach. Method Studies were identified through systematic searches (PubMed, PsycINFO, EMBASE, Cochrane Library). Deterioration in participants was defined as a significant symptom increase according to the reliable change index (i.e. 7.68 points in the CES-D; 7.63 points in the BDI). Two-step IPDMA procedures, with a random-effects model were used to pool data. Results A total of 18 studies (21 comparisons, 2079 participants) contributed data to the analysis. The risk for a reliable deterioration from baseline to post-treatment was significantly lower in the intervention v. control conditions (3.36 v. 7.60; relative risk 0.47, 95% confidence interval 0.29–0.75). Education moderated effects on deterioration, with patients with low education displaying a higher risk for deterioration than patients with higher education. Deterioration rates for patients with low education did not differ statistically significantly between intervention and control groups. The benefit–risk ratio for patients with low education indicated that 9.38 patients achieve a treatment response for each patient experiencing a symptom deterioration. Conclusions Internet-based guided self-help is associated with a mean reduced risk for a symptom deterioration compared to controls. Treatment and symptom progress of patients with low education should be closely monitored, as some patients might face an increased risk for symptom deterioration. Future studies should examine predictors of deterioration in patients with low education.
Background Though the phenotype of anxiety about medical illness has long been recognized, there continues to be debate as to whether it is a distinct psychiatric disorder and, if so, to which diagnostic category it belongs. Our objective was to investigate the pattern of psychiatric co-morbidity in hypochondriasis and to assess the relationship of health anxiety to anxiety, depressive, and somatoform disorders. Methods Data were collected as part of a clinical trial on treatment methods for hypochondriasis. 194 participants meeting criteria for DSM-IV hypochondriasis were assessed by sociodemographic variables, results of structured diagnostic interviews, and validated instruments for assessing various symptom dimensions of psychopathology. Results The majority of individuals with hypochondriasis had co-morbid psychiatric illness; the mean number of co-morbid diagnoses was 1.4, and 35.1% had hypochondriasis as their only diagnosis. Participants were more likely to have only co-morbid anxiety disorders than only co-morbid depressive or somatoform disorders. Multiple regression analysis of continuous measures of symptoms revealed the strongest correlation of health anxiety with anxiety symptoms, and a weaker correlation with somatoform symptoms; in multiple regression analysis, there was no correlation between health anxiety and depressive symptoms. Conclusion Our findings suggest that the entity of health anxiety (Hypochondriasis in DSM-IV, Illness Anxiety Disorder in DSM-5) is a clinical syndrome distinct from other psychiatric disorders. Analysis of co-morbidity patterns and continuous measures of symptoms suggest its appropriate classification is with anxiety rather than somatoform or mood disorders.
ObjectivePatients’ expectations—as a central mechanism of placebo and nocebo effects—are an important predictor of health outcomes. However, the lack of a way to assess expectations across different settings restricts progress in understanding the role of expectations and to quantify their importance in medical and psychological treatments. The aim of this study was to develop a theory-based, generic, multidimensional measure assessing patient expectations of medical and psychological treatments.DesignThe Treatment Expectation Questionnaire (TEX-Q) was developed based on the integrative model of expectations and a systematic literature review of treatment expectation scales. After creating a comprehensive item pool, the scale was further refined by use of expert ratings and patient interviews.SettingPatients were recruited in primary care at two hospitals in Hamburg, Germany.Participants13 scientific experts participated in the expert survey. 11 patients waiting for psychological or surgical treatments participated in the qualitative interviews.ResultsThe 2×2×2 multidimensional structure of the TEX-Q assesses two expectation constructs (probabilistic vs value-based) across two outcome domains with two valences (direct benefits and adverse events, broader positive and negative impact), plus process and behavioural control expectations. We examined 583 items from 38 scales identified in the systematic review and developed 78 initial items. Content validity was then rated by experts according to item fit and comprehensibility. The best 53 items were further evaluated for comprehensibility, acceptability, phrasing preference and understanding by interviewing patients prior to treatment using the ‘think aloud’ technique. This resulted in a first 35-item version of the TEX-Q.ConclusionsThe TEX-Q is a generic, multidimensional measure to assess patient expectations of medical and psychological treatments and allows comparison of the impact of multidimensional expectations across different conditions. The final TEX-Q will be available after psychometric validation.
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