Objective: Psychological distress is common among patients with chronic kidney disease and can interfere with disease self-management. We assessed the effectiveness of the personalized E-GOAL... Show moreObjective: Psychological distress is common among patients with chronic kidney disease and can interfere with disease self-management. We assessed the effectiveness of the personalized E-GOAL electronic health care pathway with screening and cognitive-behavioral therapy including self-management support, aimed to treat psychological distress and facilitate self-management among people with chronic kidney disease not on dialysis (N = 121). Methods: Primary outcome of the open two-arm parallel randomized controlled trial in four Dutch hospitals was psychological distress at posttest directly after the intervention and at 3-month follow-up. Secondary outcomes were physical and mental health-related quality of life, self-efficacy, chronic disease self-management, and personalized outcomes, that is, perceived progress compared with the previous time point on functioning (e.g., mood or social functioning) and self-management (e.g., dietary or medication adherence) outcomes that were prioritized by each individual. Results: Linear mixed-effects analyses showed no significant time-by-group interaction effects for psychological distress, health-related quality of life, self-efficacy, and chronic condition self-management, whereas analyses of covariance showed significantly more perceived progress in the intervention group at posttest on personally prioritized areas of functioning (b = 0.46, 95% confidence interval = 0.07-0.85) and self-management (b = 0.55, 95% confidence interval = 0.16-0.95), with Cohen d values of 0.46 and 0.54 (medium effects), respectively. Effects on personalized outcomes were maintained at follow-up. Conclusions: Compared with regular care only, the electronic health intervention did not reduce psychological distress, whereas personalized outcomes did improve significantly after intervention. Future studies could consider personalized outcomes that reflect individually relevant areas and treatment goals, matching person-tailored treatments. Show less
Wolters, F.; Middendorp, H. van; Bergh, O. van den; Biermasz, N.R.; Meijer, O.C.; Evers, A.W.M. 2023
Background: The hormone cortisol plays important roles in human circadian and stress physiology and is an interesting target for interventions. Cortisol varies not only in response to stress but... Show moreBackground: The hormone cortisol plays important roles in human circadian and stress physiology and is an interesting target for interventions. Cortisol varies not only in response to stress but also as part of a diurnal rhythm. It shows a particularly sharp increase immediately after awakening, the cortisol awakening response (CAR). Cortisol can be affected by medication, but it is less clear whether it can also be affected by learning. Animal studies have consistently shown that cortisol can be affected by pharmacological conditioning, but the results in humans have been mixed. Other studies have suggested that conditioning is also possible during sleep and that the diurnal rhythm can be conditioned, but these findings have not yet been applied to cortisol conditioning. Objective: The objective of our study was to introduce a novel avenue for conditioning cortisol: by using the CAR as an unconditioned response and using scent conditioning while the participant is asleep. This study investigates an innovative way to study the effects of conditioning on cortisol and the diurnal rhythm, using a variety of devices and measures to make measurement possible at a distance and at unusual moments. Methods: The study protocol takes 2 weeks and is performed from the participant's home. Measures in week 1 are taken to reflect the CAR and waking under baseline conditions. For the first 3 nights of week 2, participants are exposed to a scent from 30 minutes before awakening until their normal time of awakening to allow the scent to become associated with the CAR. On the final night, participants are forced to wake 4 hours earlier, when cortisol levels are normally low, and either the same (conditioned group) or a different (control group) scent is presented half an hour before this new time. This allows us to test whether cortisol levels are higher after the same scent is presented. The primary outcome is the CAR, assessed by saliva cortisol levels, 0, 15, 30, and 45 minutes after awakening. The secondary outcomes are heart rate variability, actigraphy measures taken during sleep, and self-reported mood after awakening. To perform manipulations and measurements, this study uses wearable devices, 2 smartphone apps, web-based questionnaires, and a programmed scent device. Results: We completed data collection as of December 24, 2021. Conclusions: This study can provide new insights into learning effects on cortisol and the diurnal rhythm. If the procedure does affect the CAR and associated measures, it also has potential clinical implications in the treatment of sleep and stress disorders. Trial Registration: Netherlands Trial Register NL58792.058.16; https://trialsearch.who.int/Trial2.aspx?TrialID=NL7791 International Registered Report Identifier (IRRID): DERR1-10.2196/38087 Show less
Background: Erythrodermic cutaneous T-cell lymphoma (E-CTCL) is associated with a poor prognosis and severe symptoms. Objective: To establish insights into the quality of life (QoL), expectations,... Show moreBackground: Erythrodermic cutaneous T-cell lymphoma (E-CTCL) is associated with a poor prognosis and severe symptoms. Objective: To establish insights into the quality of life (QoL), expectations, and treatment satisfaction of E-CTCL patients receiving mogamulizumab. Methods: Outcomes of this prospective cohort study conducted between September 2020 and August 2021 at the Leiden University Medical Center included the dermatology-specific QoL (Skindex-29), health-related QoL (RAND-12), degree of itch, pain, and fatigue (Visual Analogue Scale), patient’s expectations, and treatment satisfaction (Client Satisfaction Questionnaire-8 (CSQ-8)), measured at baseline and after six months. Results: 13 patients with E-CTCL were included. Most patients anticipated a positive treatment effect on symptoms. Five patients (46%) improved one or more clinical categories regarding the symptoms domain, six (55%) regarding emotions, four (36%) regarding functioning, and four (36%) regarding the overall Skindex-29 score compared to baseline. The Mental Component Score clinically improved from 31 (IQR 29–51) at baseline to 38 (IQR 25–51). The median VAS itch improved significantly from baseline (8 (IQR 7–10) vs. 3 (IQR 1–8), p = 0.024). Most patients (n = 7) were “very satisfied” with their treatment. Limitations: There was a limited number of patients due to the rarity of the disease. Conclusion: In general, mogamulizumab has a favorable effect on biochemical- and dermatology-specific QoL and physical functioning in some patients, with high treatment satisfaction. Itch especially improved over time in most patients. The treatment satisfaction was generally high. Mogamulizumab seems to be an effective treatment that improves the QoL in patients with E-CTCL. Show less
Background: Chronic pain has a large individual and societal burden. Previous reviews have shown that internetbased cognitive-behavioral therapy (iCBT) can support patients' pain coping. However,... Show moreBackground: Chronic pain has a large individual and societal burden. Previous reviews have shown that internetbased cognitive-behavioral therapy (iCBT) can support patients' pain coping. However, factors related to participant experience of iCBT and effective and safe iCBT delivery for chronic pain have not recently been summarized. Objective: The aim of this review was to give an overview of the efficacy of guided iCBT for chronic pain on psychological, physical, and impact on daily life outcomes, including factors that inform optimal delivery. Methods: Cochrane, Emcare, Web of Science, PubMed, PsycINFO, and Embase were systematically searched from inception to 11 February 2022. Randomized controlled trials on guided iCBTs for adults with chronic pain were included with a broad range of outcomes. Results: The search yielded 7406 studies of which 33 studies were included totaling 5133 participants. ICBT was more effective than passive control conditions for psychological (ES = 0.34-0.47), physical (ES = 0.26-0.29), and impact outcomes (ES = 0.38-0.41). ICBT was more effective than active control conditions for distress (ES = 0.40), pain acceptance (ES = 0.15), and pain interference after outlier removal (ES = 0.30). Longer treatments were associated with larger effects for anxiety and quality of life than shorter treatments. Mode of therapist contact (synchronous, asynchronous or a mix of both) was not related to differences in effect sizes in most outcomes. However, studies with mixed and synchronous contact modes had higher effects on pain self-efficacy than studies with asynchronous contact modes. Treatment satisfaction was high and adverse events were minor. Dropout was related to time, health, technical issues, and lack of computer skills. Conclusions: Guided iCBT is an effective and potentially safe treatment for chronic pain. Future research should more consistently report on iCBT safety and detail the effectiveness of individual treatment components to optimize iCBT in clinical practice. Show less
Learning and negative outcome expectations can increase pain sensitivity, a phenomenon known as nocebo hyperalgesia. Here, we examined how a targeted pharmacological manipulation of learning would... Show moreLearning and negative outcome expectations can increase pain sensitivity, a phenomenon known as nocebo hyperalgesia. Here, we examined how a targeted pharmacological manipulation of learning would impact nocebo responses and their brain correlates. Participants received either a placebo (n = 27) or a single 80 mg dose of d-cycloserine (a partial NMDA receptor agonist; n = 23) and underwent fMRI. Behavioral conditioning and negative suggestions were used to induce nocebo responses. Participants underwent pre-conditioning outside the scanner. During scanning, we first delivered baseline pain stimulations, followed by nocebo acquisition and extinction phases. During acquisition, high intensity thermal pain was paired with supposed activation of sham electrical stimuli (nocebo trials), whereas moderate pain was administered with inactive electrical stimulation (control trials). Nocebo hyperalgesia was induced in both groups (p < 0.001). Nocebo magnitudes and brain activations did not show significant differences between d-cycloserine and placebo. In acquisition and extinction, there were significantly increased activations bilaterally in the amygdala, ACC, and insula, during nocebo compared to control trials. Nocebo acquisition trials also showed increased vlPFC activation. Increased opercular activation differentiated nocebo-augmented pain aggravation from baseline pain. These results support the involvement of integrative cognitive-emotional processes in nocebo hyperalgesia. Show less
Background (Instrumental) activities of daily living ((I)ADL) questionnaires are often used as a measure of functioning for different purposes. Depending on the purpose, a measurement of... Show moreBackground (Instrumental) activities of daily living ((I)ADL) questionnaires are often used as a measure of functioning for different purposes. Depending on the purpose, a measurement of functioning that includes subjective patient perspectives can be relevant. However, it is unclear to what extent (I)ADL instruments capture self-perceived functioning. Objective Explore what functioning means to older persons after a hip fracture and assess the extent to which (I)ADL instruments align with self-perceived functioning. Design Qualitative interview study with framework analysis. Setting Prospective cohort study on recovery after a hip fracture among older persons in a hospital in a large city in the west of the Netherlands. Subjects Eighteen home-dwelling older persons (>= 70 years) who had a hip fracture 6-12 months ago. Methods Telephone interviews about functioning before and after the hip fracture were coded and analysed using the framework method. Results The activities mentioned by participants to be part of their self-perceived functioning could be split into activities necessary to maintain the desired level of independence, and more personal activities that were of value to participants. Both the 'independence activities' and the 'valued activities' mentioned went beyond the activities included in (I)ADL questionnaires. Due to various coping strategies, limitations in activities that are measured in the (I)ADL questionnaires did not necessarily lead to worse self-perceived functioning. Conclusion Self-perceived functioning differs from functioning measured with (I)ADL questionnaires in the items included and the weighing of limitations in activities. Thus, (I)ADL instruments alone are not enough to measure functioning from the perspective of the older person. Show less
