Mechthild Hartmann

Sustained Effects of a Mindfulness-Based Stress-Reduction Intervention in Type 2 Diabetic Patients Design and first results of a randomized controlled trial (The Heidelberger Diabetes and Stress-Study)

OBJECTIVE To determine whether a mindfulness-based stress reduction (MBSR) intervention is effective for reducing psychosocial distress (i.e., depression, psychosocial stress) and the progression of nephropathy (i.e., albuminuria) and for improving the subjective health status of patients with type 2 diabetes. RESEARCH DESIGN AND METHODS Patients with type 2 diabetes and microalbuminuria were randomized to a mindfulness-based intervention (n = 53) or a treatment-as-usual control (n = 57) group. The study is designed to investigate long-term outcomes over a period of 5 years. We present data up to the first year of follow-up (FU). RESULTS At FU, the MBSR group showed lower levels of depression (d = 0.71) and improved health status (d = 0.54) compared with the control group. No significant differences in albuminuria were found. Per-protocol analysis also showed higher stress reduction in the intervention group (d = 0.64). CONCLUSIONS MBSR intervention achieved a prolonged reduction in psychosocial distress. The effects on albuminuria will be followed up further.

Training cognitive flexibility in patients with anorexia nervosa: A pilot randomized controlled trial of cognitive remediation therapy

OBJECTIVE Inefficient cognitive flexibility is considered a neurocognitive trait marker involved in the development and maintenance of anorexia nervosa (AN). Cognitive Remediation Therapy (CRT) is a specific treatment targeting this cognitive style. The aim of this study was to investigate the feasibility and efficacy (by estimating the effect size) of specifically tailored CRT for AN, compared to non-specific cognitive training. METHOD A prospective, randomized controlled, superiority pilot trial was conducted. Forty women with AN receiving treatment as usual (TAU) were randomized to receive either CRT or non-specific neurocognitive therapy (NNT) as an add-on. Both conditions comprised 30 sessions of computer-assisted (21 sessions) and face-to-face (9 sessions) training over a 3-week period. CRT focused specifically on cognitive flexibility. NNT was comprised of tasks designed to improve attention and memory. The primary outcome was performance on a neuropsychological post-treatment assessment of cognitive set-shifting. RESULTS Data available from 25 treatment completers were analyzed. Participants in the CRT condition outperformed participants in the NNT condition in cognitive set-shifting at the end of the treatment (p = 0.027; between-groups effect size d = 0.62). Participants in both conditions showed high treatment acceptance. DISCUSSION This study confirms the feasibility of CRT for AN, and provides a first estimate of the effect size that can be achieved using CRT for AN. Furthermore, the present findings corroborate that neurocognitive training for AN should be tailored to the specific cognitive inefficiencies of this patient group.

Reward-related decision making in eating and weight disorders: A systematic review and meta-analysis of the evidence from neuropsychological studies.

Eating disorders (EDs) and overweight/obesity (OW/OB) are serious public health concerns that share common neuropsychological features and patterns of disturbed eating. Reward-related decision making as a basic neurocognitive function may trans-diagnostically underlie both pathological overeating and restricted eating. The present meta-analysis synthesizes the evidence from N=82 neuropsychological studies for altered reward-related decision making in all ED subtypes, OW and OB. The overall effect sizes for the differences between currently-ill ED patients and OW/OB people and controls were Hedges g=-0.49 [CI: -0.63; -0.35], and Hedges g=-0.39 [CI: -0.53; -0.25], respectively. Decision making was found to be altered to similar degrees in all ED subtypes and OB. Effect sizes, however, diverged for the different measures of decision making. Adolescents appear to be less affected than adults. When foods were used as rewarding stimuli, decision making was found to be intact in OB. The findings support that altered general reward-related decision making is a salient neuropsychological factor across eating and weight disorders in adulthood.

Treatment decision-making in localized prostate cancer: why patients chose either radical prostatectomy or external beam radiation therapy

Study Type – Therapy (case series)

The Prevalence Rate and the Role of the Spatial Extent of Pain in Nonspecific Chronic Back Pain—A Population-Based Study in the South-West of Germany

OBJECTIVE To determine the prevalence of chronic back pain in the general population and to establish an evidence-based subclassification system for chronic back pain based on pain extent. DESIGN Representative population-based survey. SETTING South-western Germany. SUBJECTS Four-thousand representative residents were contacted. The corrected response rate was 61.8% (N = 2,408). Those suffering from chronic back pain (pain ≥45 days/last 3 months) were invited to a clinical evaluation. OUTCOME MEASURES Chronic back pain, spatial extent of pain, sociodemographic and clinical variables. RESULTS Age- and sex-adjusted prevalence rate for chronic back pain was 17.7%. Analyzing pain extent, we found that only 19.6% suffered strictly from chronic local back pain, while the majority indicated additional pain regions. Thus, we developed a subclassification system based on pain extent that consists of four more homogeneous groups (19.6% strict chronic local pain, 42.1% chronic regional pain, 24.3% common chronic widespread pain, 13.9% extreme chronic widespread pain). Interestingly, in this system, increasing pain extent was significantly associated with higher distress, as reflected by sociodemographic (e.g., lower education, lower social class, and higher application rate for disability pension) and clinical variables (e.g., higher pain intensity, more pain medication, more consultations, higher impairment, and lower quality of life). CONCLUSIONS Chronic back pain is prevalent and usually involves additional pain areas outside of the back. This challenges the concept of chronic back pain as a distinct entity. To identify patients who are distressed by chronic back pain, a four-class taxonomy based on pain drawings is both feasible and clinically useful.

Dynamic analysis of electronic diary data of obese patients with and without binge eating disorder.

250 therapy could produce an extra unit of outcomes at a cost of GBP 53 (EUR 76) or it could be dominated by BTSteps (i.e. the latter would have lower costs and better outcomes). Figure 1 shows the cost-effectiveness acceptability curves. The two active treatments become more cost-effective than relaxation at the points indicated by the ICERs, i.e. GBP 66 (EUR 95) for BTSteps and GBP 90 (EUR 130) for clinician-guided therapy. For values between around GBP 40 (EUR 58) and GBP 133 (EUR 192), BTSteps has more chance of being cost-effective compared to relaxation than does clinician-guided therapy. For values above this range, clinician-guided therapy is more cost-effective than BTSteps. In the original RCT, BTSteps and clinician-guided therapy were more effective than relaxation, and BTSteps was less effective than clinician-guided ERP. However, BTSteps costs less, and there is a high probability that BTSteps is the most cost-effective option for modest values placed on a one-unit fall in the YBOCS. Clinician-guided therapy would be more cost-effective than BTSteps only if a unit reduction in the YBOCS was valued at around GBP 133 (EUR 192) or above. However, even if this were acceptable it ignores the fact that there is likely to be a limit on the number of therapists available. Therefore, the difference in costeffectiveness may be greater than presented here. The original trial did not collect detailed resource-use information. We could only cost the therapies themselves and not other health services or lost employment. Therefore the perspective is limited. We also had to make an assumption about the proportion of clinician-guided therapy sessions attended (75%) that may not be accurate. The main outcome measure is syndrome specific, making comparisons elsewhere problematic. Behaviour therapists for OCD are scarce and they have many competing demands on their time. This study suggests that computer-aided therapy can be a cost-effective alternative for OCD.

Subgroups of musculoskeletal pain patients and their psychobiological patterns – The LOGIN study protocol

BackgroundPain conditions of the musculoskeletal system are very common and have tremendous socioeconomic impact. Despite its high prevalence, musculoskeletal pain remains poorly understood and predominantly non-specifically and insufficiently treated.The group of chronic musculoskeletal pain patients is supposed to be heterogeneous, due to a multitude of mechanisms involved in chronic pain. Psychological variables, psychophysiological processes, and neuroendocrine alterations are expected to be involved. Thus far, studies on musculoskeletal pain have predominantly focused on the general aspects of pain processing, thus neglecting the heterogeneity of patients with musculoskeletal pain. Consequently, there is a need for studies that comprise a multitude of mechanisms that are potentially involved in the chronicity and spread of pain. This need might foster research and facilitate a better pathophysiological understanding of the condition, thereby promoting the development of specific mechanism-based treatments for chronic pain. Therefore, the objectives of this study are as follows: 1) identify and describe subgroups of patients with musculoskeletal pain with regard to clinical manifestations (including mental co-morbidity) and 2) investigate whether distinct sensory profiles or 3) distinct plasma levels of pain-related parameters due to different underlying mechanisms can be distinguished in various subgroups of pain patients.Methods/DesignWe will examine a population-based chronic pain sample (n = 100), a clinical tertiary care sample (n = 100) and pain-free patients with depression or post-traumatic stress disorder and pain-free healthy controls (each n = 30, respectively). The samples will be pain localisation matched by sex and age to the population-based sample. Patients will undergo physical examination and thorough assessments of mental co-morbidity (including psychological trauma), perceptual and central sensitisation (quantitative sensory testing), descending inhibition (conditioned pain modulation, the diffuse noxious inhibitory control-like effect), as well as measurement of the plasma levels of nerve growth factor and endocannabinoids.DiscussionThe identification of the underlying pathophysiologic mechanisms in different subgroups of chronic musculoskeletal pain patients will contribute to a mechanism-based subgroup classification. This will foster the development of mechanism-based treatments and holds promise to treat patients more sufficient.

Psychosocial and physical outcome following kidney donation-a retrospective analysis.

Living renal donation is of benefit to the allograft recipient. Careful analysis of the donor outcome is necessary with respect to the medical condition, socioeconomic status, and health‐related quality of life. All living kidney donors of the Transplant Center at Heidelberg were included. Renal function and comorbidities were assessed. HRQoL and fatigue symptoms were determined by self‐reporting validated test systems [Short‐Form 36 (SF‐36), Multidimensional Fatigue Inventory (MFI‐20), Patient Health Questionnaire (PHQ)]. In total, 430 of 519 living renal donors were eligible to participate: 295 living donors (68.6%) provided informed consent (age at donation 49 ± 11 years) with a median time after donation of 77 (24–484) months. Renal function was lower compared with predonation (66 ± 15 ml/min vs. 88 ± 14 ml/min). Blood pressure remained stable (128 ± 14 mmHg vs. 129 ± 15 mmHg) with an increase of 56 donors receiving antihypertensive treatment (27.1% vs. 19%). The SF‐36 physical component summary score was significantly better for both genders compared with the general population; the SF‐36 mental component summary score was lower for female donors, caused by a reduced role functioning. Prevalence of fatigue was increased in female donors between the ages of 40 and 59 years. Renal function and blood pressure were as expected from previous studies. Concerning the psychosocial outcome, female donors might be at risk of impairments postdonation. Future evaluations will confirm and specify whether these results are necessary.

Brain effects of computer-assisted cognitive remediation therapy in anorexia nervosa: A pilot fMRI study

Poor cognitive-behavioral flexibility is considered a trait marker in anorexia nervosa (AN) that can be improved by cognitive remediation therapy (CRT). The present pilot study aimed at identifying changes in brain function potentially associated with CRT in AN. Data was obtained from a randomized, controlled trial. Twenty-four patients were assessed before and after 30 sessions of either CRT or a non-specific neurocognitive therapy. Voxel-wise analysis of whole brain functional magnetic resonance imaging was applied. Brain activation was measured during response inhibition and task switching. Although results did not reach significance, we found tentative support for CRT-related increases in brain activation in the dorsal putamen during task switching and in the dorsolateral prefrontal, sensorimotor and temporal cortex during response inhibition. These pilot findings provide viable pathways for future research on brain changes underlying CRT in AN.

Eye Movement Desensitization and Reprocessing vs. Treatment-as-Usual for Non-Specific Chronic Back Pain Patients with Psychological Trauma: A Randomized Controlled Pilot Study.

Objective Eye movement desensitization and reprocessing (EMDR)—an evidence-based approach to eliminate emotional distress from traumatic experiences—was recently suggested for the treatment of chronic pain. The aim of this study was to estimate preliminary efficacy of a pain-focused EMDR intervention for the treatment of non-specific chronic back pain (CBP). Design Randomized controlled pilot study. Methods 40 non-specific CBP (nsCBP) patients reporting previous experiences of psychological trauma were consecutively recruited from outpatient tertiary care pain centers. After baseline assessment, patients were randomized to intervention or control group (1:1). The intervention group received 10 sessions standardized pain-focused EMDR in addition to treatment-as-usual (TAU). The control group received TAU alone. The primary outcome was preliminary efficacy, measured by pain intensity, disability, and treatment satisfaction from the patients’ perspective. Clinical relevance of changes was determined according to the established recommendations. Assessments were conducted at the baseline, posttreatment, and at a 6-month follow-up. Intention-to-treat analysis with last observation carried forward method was used. Registered with http://ClinicalTrials.gov (NCT01850875). Results Estimated effect sizes (between-group, pooled SD) for pain intensity and disability were d = 0.79 (CI95%: 0.13, 1.42) and d = 0.39 (CI95%: −0.24, 1.01) posttreatment, and d = 0.50 (CI95%: 0.14, 1.12) and d = 0.14 (CI95%: −0.48, 0.76) at 6-month follow-up. Evaluation on individual patient basis showed that about 50% of the patients in the intervention group improved clinically relevant and also rated their situation as clinically satisfactory improved, compared to 0 patients in the control group. Conclusion There is preliminary evidence that pain-focused EMDR might be useful for nsCBP patients with previous experiences of psychological trauma, with benefits for pain intensity maintained over 6 months.