Personalized versus standard cognitive behavioral therapy for fear of cancer recurrence, depressive symptoms or cancer-related fatigue in cancer survivors:study protocol of a randomized controlled trial (MATCH-study)

Abstract Background Fear of cancer recurrence, depressive symptoms, and cancer-related fatigue are prevalent symptoms among cancer survivors, adversely affecting patients’ quality of life and daily functioning. Effect sizes of interventions targeting these symptoms are mostly small to medium. Personalizing treatment is assumed to improve efficacy. However, thus far the empirical support for this approach is lacking. The aim of this study is to investigate if systematically personalized cognitive behavioral therapy is more efficacious than standard cognitive behavioral therapy in cancer survivors with moderate to severe fear of cancer recurrence, depressive symptoms, and/or cancer-related fatigue. Methods The study is designed as a non-blinded, multicenter randomized controlled trial with two treatment arms (ratio 1:1): (a) systematically personalized cognitive behavioral therapy and (b) standard cognitive behavioral therapy. In the standard treatment arm, patients receive an evidence-based diagnosis-specific treatment protocol for fear of cancer recurrence, depressive symptoms, or cancer-related fatigue. In the second arm, treatment is personalized on four dimensions: (a) the allocation of treatment modules based on ecological momentary assessments, (b) treatment delivery, (c) patients’ needs regarding the symptom for which they want to receive treatment, and (d) treatment duration. In total, 190 cancer survivors who experience one or more of the targeted symptoms and ended their medical treatment with curative intent at least 6 months to a maximum of 5 years ago will be included. Primary outcome is limitations in daily functioning. Secondary outcomes are level of fear of cancer recurrence, depressive symptoms, fatigue severity, quality of life, goal attainment, therapist time, and drop-out rates. Participants are assessed at baseline (T0), and after 6 months (T1) and 12 months (T2). Discussion To our knowledge, this is the first randomized controlled trial comparing the efficacy of personalized cognitive behavioral therapy to standard cognitive behavioral therapy in cancer survivors. The study has several innovative characteristics, among which is the personalization of interventions on several dimensions. If proven effective, the results of this study provide a first step in developing an evidence-based framework for personalizing therapies in a systematic and replicable way. Trial registration The Dutch Trial Register (NTR) NL7481 (NTR7723). Registered on 24 January 2019

A cross-sectional study on fatigue, anxiety, and symptoms of depression and their relation with medical status in adult patients with Marfan syndrome:Psychological consequences in Marfan syndrome

Marfan syndrome (MFS) is a connective tissue disorder affecting the cardiovascular, ocular, and skeletal system, which may be accompanied by psychological features. This study aimed to determine the prevalence of fatigue, anxiety, and symptoms of depression in MFS patients, and to assess the degree to which sociodemographic and clinical variables are associated with fatigue and psychological aspects. The prevalence of fatigue, anxiety, and symptoms of depression were assessed in two cohorts of MFS patients and compared with healthy controls. The checklist individual strength (CIS), and hospital anxiety and depression scale (HADS) questionnaires were utilized. Medical status was assessed (family history of MFS, aortic root dilatation >40 mm, previous aortic surgery, aortic dissection, chronic pain, skeletal involvement, and scoliosis). Severe fatigue was experienced by 37% of the total MFS cohort (n = 155). MFS patients scored significantly higher on the CIS questionnaire, concerning severe fatigue, as compared with the general Dutch population (p < 0.0001). There were no differences in HADS anxiety or depression scores. In older MFS patients, with a more severe cardiovascular phenotype, chronic pain, and a higher unemployment rate, significantly more symptoms of depression were observed, when compared with the general population (p = 0.027) or compared with younger MFS patients (p = 0.026). Multivariate analysis, showed that anxiety was associated with chronic pain (p = 0.022) and symptoms of depression with unemployment (p = 0.024). MFS patients report significantly more severe fatigue as compared with the general population. Since the cause of fatigue is unclear, more research may be needed. Psychological intervention, for example, cognitive behavioral therapy, may contribute to a reduction in psychological symptoms

Mental distress among adult patients with eosinophilic esophagitis

Rationale: Data on the prevalence of mental distress among adult eosinophilic esophagitis (EoE) patients are scarce. Also, a significant gap remains in the understanding of which determinants are related to significant psychological symptoms and whether distressed patients require and receive mental care. Methods: Adult EoE patients were invited to complete standardized measures on anxiety/depressive symptoms (HADS) and general psychopathology (SCL-90-R). All scores were compared to general population norms. Socio-demographic and clinical factors were assessed. Results: In total, 147 adult EoE patients (61% males, age 43 (IQR 29–52) years were included (response rate 71%). No difference with general population values was found for total anxiety and depressive symptoms (7.8 ± 6.6 vs. 8.4 ± 6.3; p = 0.31). A total of 38/147(26%) patients reported high levels of anxiety and/or depressive symptoms (HADS-A ≥ 8: 35/147(24%) and HADS-D ≥ 8: 14/147(10%)), indicative of a possible psychiatric disorder. In a multivariate analysis, age between 18–35 years was independently associated with high levels of anxiety (HADS-A ≥ 8) (OR 3.0, 95% CI 1.3–6.9; p = 0.01). The SCL-90-R Global Severity Index (GSI) was significantly higher compared to the general population (p < 0.001). Significant signs of general mental distress (GSI ≥ 80th percentile) were observed in 51(36%) EoE patients, of which 29(57%) patients denied having any mental problems and only 8(16%) patients received mental care. Conclusion: A considerable proportion of adult EoE patients suffers from mental distress, with a 3-fold risk of significant anxiety in those patients younger than 35 years. Therefore, population-based studies are required and a proactive approach in the screening for and treatment of these psychological symptoms in EoE practice seems essential

General Well-being and Coping Strategies in Adult Eosinophilic Esophagitis Patients

Background/Aims Growing evidence suggests a negative effect of eosinophilic esophagitis (EoE) on patients' general health-related quality of life (HRQOL). However, the relevance and use of coping strategies and its relation to (disease specific) HRQOL as well as its determinants have not been studied well. Methods Adult EoE patients were invited to complete standardized measures on general HRQOL (Short Form-36 Health Survey [SF-36]) and coping strategies (Utrechtse Coping Lijst [UCL]). Scores were compared to general population norms. The disease specific Adult Eosinophilic Esophagitis Quality of Life (EoE-QOL-A) measure was used to assess EoE-HRQOL. Socio-demographic-and clinical factors were also evaluated. Results In total, 147 adult EoE patients (61% males), age 43 (interquartile range, 29-52) years were analyzed. Mental health-scores (SF-36) were significantly lower in EoE patients, whereas physical health-scores (SF-36) were similar in EoE patients (vs the general population; P = 0.010 and P = 0.240), respectively. The subdomain "disease anxiety" (EoE-QOL-A) was mostly affected, determinants were; female gender, younger age, severe clinical disease activity, higher number of food bolus extraction, and more recent EoE-diagnosis. Less effective coping styles (ie, passive/palliative reaction) were associated with a significant impact on each individual EoE-HRQOLsubdomain as well as lower scores of the Mental Health Component Scale in male EoE patients. Passive reaction in female EoEpatients correlated with impairment of the EoE-HRQOL-domains "emotional impact" and "disease anxiety." Active problem solving was significantly related to better perception of mental HRQOL (SF-36) in both males and females. Conclusions EoE has a significant negative impact on mental HRQOL, with less effective coping strategies-specifically in males, being a relevant determinant. Thus, a pro-active approach towards coping mechanisms is needed in order to enhance HRQOL and manage patients' burden of EoE

I am a total failure: Associations between beliefs and anxiety and depression in patients with inflammatory bowel disease with poor mental quality of life

Background:According to cognitive behavioural theory, cognitive factors (i.e. underlying general dysfunctional beliefs and (situation) specific illness beliefs) are theorized to lead to outcomes like anxiety and depression. In clinical practice, general dysfunctional beliefs are generally not tackled directly in short-term-therapy.Aims:The goal of the present study was to investigate the associations of general versus specific illness beliefs on anxiety and depressive symptoms and psychiatric disorders among a subgroup of patients with inflammatory bowel disease (IBD) with poor mental quality of life (QoL).Method:This study concerns cross-sectional data, collected at baseline from a randomized clinical trial. One hundred and eighteen patients, recruited at four Dutch hospitals, with poor QoL (score ≤23 on the mental health subscale of the Short-Form 36-item Health-Survey; SF-36) were included. General dysfunctional beliefs were measured by the Dysfunctional Attitude Scale (DAS), specific illness beliefs by the Illness Perceptions Questionnaire-Revised (IPQ-R), anxiety and depressive symptoms by the Hospital Anxiety and Depression Scale (HADS), and psychiatric disorders by the Structured Clinical Interview for DSM-IV Axis-I Disorders (SCID-I).Results:Univariate analyses showed associations between the level of anxiety and/or depression and general dysfunctional beliefs and four specific illness beliefs (consequences, personal control, emotional representations and treatment control). Among patients with IBD with psychiatric disorders, only the DAS was significantly associated with anxiety and depression (DAS added to IPQ-R and IPQ-R added to DAS).Conclusions:Psychological interventions may have to target general dysfunctional beliefs of patients with IBD with co-morbid psychiatric disorders to be effective. These patients with IBD are especially in need of psychological treatment

The Patient Simple Clinical Colitis Activity Index (P-SCCAI) can detect ulcerative colitis (UC) disease activity in remission:A comparison of the P-SCCAI with clinician-based SCCAI and biological markers

<p>Aim: To develop a patient-based Simple Clinical Colitis Activity Index (P-SCCAI) of ulcerative colitis (UC) activity and to compare it with the clinician-based SCCAI, C-reactive protein (CRP) and Physician's Global Assessment (PGA) of UC activity. Monitoring UC activity may give patients disease control and prevent unnecessary examinations.</p><p>Methods: Consecutive UC patients randomly completed the P-SCCAI either before or after consultation. Gastroenterologists assessed patients' UC activity on the same day. Overall agreement between SCCAI and P-SCCAI was calculated with Spearman's Rho and Mann Whitney U test. Agreement regarding active disease versus remission and agreement at domain level were calculated by percent agreement and kappa (lc).</p><p>Results: 149 (response rate 84.7%) UC patients participated. P-SCCAI and SCCAI showed a large correlation (rs= 0.79). The medians (IQR) of the P-SCCAI (3.78;0-15) tended to be higher than those of the SCCAI (2.86;0-13), although this difference did not reach statistical significance (z= 1.711 p =0.088). In 77% of the cases the difference between clinicians and patients' scores was not clinically different (i.e. 2). Percentage agreement between clinicians and patients, judging UC as active or in remission, was 87%, rs = 0.66, tc=0.66, indicating a substantial agreement. In general patients tended to report more physical symptoms than clinicians. C-Reactive protein (CRP) was found to have a significant association with both P-SCCAI and SCCAI (K=0.32, K=0.39 respectively) as was PGA (K=0.73 for both indices).</p><p>Conclusions: The P-SCCAI is a promising tool given its substantial agreement with the SCCAI and its feasibility. Therefore, P-SCCAI can complement SCCAI in clinical care and research. (C) 2012 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.</p>

Implementation of 'IBD-Specific Cognitive Behavioural Therapy' for Patients with Inflammatory Bowel Diseases with Poor Mental Quality of Life, Anxiety and Depression

This paper describes the implementation of inflammatory bowel disease (IBD)-specific cognitive behavioural therapy (CBT) for IBD patients with poor quality of life (QoL), anxiety and depression, in four hospitals in the Netherlands. Treatment outcomes were compared with those of a previously published randomized control trial (RCT) of 'IBD-specific CBT', following a benchmark strategy. Primary outcome was IBD-specific QoL (IBDQ) completed before and after CBT, secondary outcomes were anxiety and depressive symptoms (HADS, CES-D). Semi-structured interviews were conducted among a pilot of gastroenterologists, nurse specialists and psychologists to evaluate 'IBD-specific CBT'. 94 patients started treatment (280 screened). At follow-up, 63 participants (67% compared to 81% in the RCT benchmark) completed the IBDQ. Treatment effect sizes of the implementation study were comparable and slightly larger than those of RCT benchmark. Gastroenterologists, IBD nurses and psychologists found CBT necessary for IBD patients with poor QoL, depression and/or anxiety disorders. 'IBD-specific CBT' can be successfully implemented. Regular supervision of psychologists performing 'IBD-specific CBT' treatment is needed.</p

Effectiveness of Cognitive-Behavioral Therapy on Quality of Life, Anxiety, and Depressive Symptoms Among Patients With Inflammatory Bowel Disease: A Multicenter Randomized Controlled Trial

OBJECTIVE: Inflammatory bowel disease (IBD) is characterized by a low level of quality of life (QoL) and a high prevalence of anxiety and depression, especially in patients with poor QoL. We examined the effect of IBD-specific cognitive-behavioral therapy (CBT) on QoL, anxiety, and depression in IBD patients with poor mental QoL. METHOD: This study is a parallel-group multicenter randomized controlled trial. One hundred eighteen IBD patients with a low level of QoL (score ≤23 on the mental health subscale of the Medical Outcomes Study Short Form 36 Health Survey [SF-36]) were included from 2 academic medical centers (Academic Medical Center Amsterdam, VU University Medical Centre Amsterdam) and 2 peripheral medical centers (Flevo Hospital, Slotervaart Hospital) in the Netherlands. Patients were randomized to an experimental group receiving CBT (n = 59) versus a wait-list control group (n = 59) receiving standard medical care for 3.5 months, followed by CBT. Both groups completed baseline and 3.5 months follow-up assessments. The primary outcome was a self-report questionnaire and disease-specific QoL (Inflammatory Bowel Disease Questionnaire [IBDQ]). Secondary outcomes were depression (Hospital Anxiety and Depression Scale-Depression Subscale [HADS-D], Center for Epidemiologic Studies Depression Scale [CES-D]), anxiety (HADS-Anxiety Subscale [HADS-A]) and generic QoL (SF-36). RESULTS: Data were analyzed both on intention to treat as well as on per protocol analysis (completed ≥5 sessions). CBT had a positive effect on disease-specific-QoL (Cohen's d = .64 for IBDQ total score), depression (Cohen's d = .48 for HADS-D and .78 for CES-D), anxiety (Cohen's d = .58 for HADS-A), and generic QoL (Cohen's d = 1.08 for Mental Component Summary of the SF-36; all ps < .01). CONCLUSIONS: IBD-specific CBT is effective in improving QoL and in decreasing anxiety and depression in IBD patients with poor QoL. Clinicians should incorporate screening on poor mental QoL and consider offering CBT. (PsycINFO Database Recor