PRO*BPD: effectiveness of outpatient treatment programs for borderline personality disorder: a comparison of Schema therapy and dialectical behavior therapy: study protocol for a randomized trial.

BACKGROUND: Borderline Personality Disorder (BPD) is a severe mental illness that is associated with low quality of life, low psychosocial functioning, and high societal costs. Treatments for BPD have improved in the last decades. Dialectical behavior therapy (DBT) and Schema therapy (ST) have demonstrated efficacy in reducing BPD symptoms and costs. However, research has not compared these two treatment approaches. In addition, there is a lack of 'real world studies' that replicate positive findings in regular mental healthcare settings. Thus, the PROgrams for Borderline Personality Disorder (PRO*BPD) study will compare the (cost-) effectiveness of DBT and ST in structured outpatient treatment programs in the routine clinical setting of an outpatient clinic. METHODS/DESIGN: We aim to recruit 160 BPD patients, who will be randomly assigned to either DBT or ST. In both conditions, patients receive one group therapy and one individual therapy session/week for a maximum of 18 months. Both treatment programs have similar frameworks, which guarantee clinical equipoise. The primary outcome is a reduction of BPD-symptoms. Also, the costs related to BPD are assessed and an economic evaluation is performed from a societal perspective. Secondary outcomes examine other measures of BPD-typical and general psychopathology, comorbidity, quality of life, psychosocial functioning and participation. Data are collected prior to the beginning therapy and every six months until the end of therapy, as well as at six months, one year and two years of follow-up after the end of therapy. Finally, we conduct a qualitative study to understand patients' experiences with the two methods. DISCUSSION: The PRO*BPD study is the first randomized trial to compare the (cost-) effectiveness of DBT and ST. By examining the clinical effectiveness of a broad spectrum of outcome parameters, conducting an economic evaluation and assessing patients' experiences, this study will significantly advance our knowledge on psychotherapy for BPD and will provide insight into the treatment approaches that should be offered to different BPD patients from clinical, economic and stakeholder's perspectives. TRIAL REGISTRATION: German Clinical Trial Register, DRKS00011534 , Date of registration: 11/01/2017, retrospectively registered.

[Chronic tinnitus: which kind of patients benefit from an outpatient psychotherapy?]. / Chronischer Tinnitus: Für wen ist eine ambulante Kurzzeitpsychotherapie indiziert?

BACKGROUND: Psychotherapy proved to be effective in the treatment of chronic tinnitus sufferers. We investigated, which patient and symptom characteristics predicted the treatment outcome. PATIENTS AND METHODS: 95 patients underwent a CBT based treatment including biofeedback elements. Predictors were identified by the use of regression analysis. Outcome was defined as changes in tinnitus annoyance, intensity, duration, the number of responder and the end-state-functioning. RESULTS: More than 80% of the participants significantly improved. Positive predictors found in the analysis were an active and non-sceptical treatment expectancy. If patients suffered from depressive disorder, outcome was slightly reduced. CONCLUSION: Most tinnitus patients benefit from outpatient psychotherapy. Positive treatment expectancy should be increased at the beginning of the treatment. Patients who are sceptical should be informed about potential positive treatment results. In the case of affective disorder, additional treatments should be considered.

Psychophysiological effects of biofeedback treatment in tinnitus sufferers.

OBJECTIVES: Psychophysiological factors in maintaining tinnitus-related distress have been emphasized in current tinnitus models. Hyperreactivity in the autonomous nervous system is supposed to hinder habituation processes and might contribute to maladjustment to tinnitus symptoms in the long run. Accordingly, biofeedback treatment targeting physiological activity ought to reduce tinnitus annoyance and facilitate habituation. SUBJECTS: One hundred and thirty patients completed a manual-based psychological treatment especially developed for chronic tinnitus sufferers. A subsample consisting of 67 participants were randomly assigned to a waiting list (3 months) and served as a control group. The programme consisted of 15 sessions of cognitive-behavioural therapy combined with a psychophysiological treatment using a biofeedback approach. METHODS: Different muscle regions of the head and neck and skin conductance level were assessed with biofeedback equipment. Physiological treatment effects were analysed using the pre-post effect sizes in comparison to the wait list group. Correlations for physiological changes and psychological treatment effects were computed. RESULTS: Moderate to large effect sizes for physiological changes were demonstrated. Physiological and psychological treatment effects were found to be unrelated. DISCUSSION: Our treatment approach, which combined biofeedback therapy with CBT elements, was found to be highly effective in reducing psychophysiological activation. Psychological and physiological variables seem to represent independent response systems.

Stability of physiological variables in chronic tinnitus sufferers.

The etiological tinnitus models propose that suffering can be caused and aggravated by heightened physiological arousal. Therefore psychophysiological treatments are applied. Stability of the measured parameters is essential for the use of biofeedback as well as to permit the attribution of changes to the administered treatment. The aim of our study was to investigate the 3-month reproducibility of psychophysiological parameters in 60 tinnitus patients. Using a repeated-measures design, the activity of these parameters was assessed twice during various stress and relaxation trials. The results showed that the measurements of frontalis, masseter and trapezius muscles were stable, while for the sternocleidomastoid, the skin conductance level (SCL) and the skin temperature retest-stability could not be evidenced. For all parameters, test-retest stability was weak for the relative scores. In conclusion, our study has important implications for applied psychophysiology research: (1) the measurement of EMG assessed in a clinical sample is stable over a 3-month interval; (2) in contrast, the measurements of SCL and skin temperature as well as all relative scores are less stable; and (3) the stability of EMG-parameters in our sample gives first hints that physiological changes can be attributed to an administered biofeedback treatment but further research is required.

Physiological and psychological stress reactivity in chronic tinnitus.

Several models of tinnitus maintenance emphasize the importance of cognitive, emotional and psychophysiological processes. These factors contribute to distress in patients with decompensated tinnitus symptoms. We investigated whether tinnitus patients show increased physiological levels of arousal, more intense stress reactivity patterns and exaggerated psychological strain compared to healthy controls. Seventy tinnitus patients and 55 healthy controls underwent various stress tests. Muscular reactivity and peripheral arousal as well as strain ratings were assessed. Tinnitus patients reported significantly more strain during stress tests compared to healthy controls. Few physiological reactivity patterns differed significantly between the two groups. The physiological data thus only partly supported a hyperreactivity hypothesis. Strain reports and physiological data were only marginally correlated. Tinnitus patients show maladaptive appraisal processes during stress exposure, yet physiological reactivity is only slightly affected. Treatment programs for patients with decompensated tinnitus symptoms should account for appraisal processes and coping mechanisms in stressful situations.

Biofeedback-based behavioral treatment for chronic tinnitus: results of a randomized controlled trial.

Many tinnitus sufferers believe that their tinnitus has an organic basis and thus seek medical rather than psychological treatments. Tinnitus has been found to be associated with negative appraisal, dysfunctional attention shift, and heightened psychophysiological arousal, so cognitive-behavioral interventions and biofeedback are commonly suggested as treatments. This study developed and investigated the efficacy of a biofeedback-based cognitive-behavioral treatment for tinnitus. In total, 130 tinnitus patients were randomly assigned to an intervention or a wait-list control group. Treatment consisted of 12 sessions of a biofeedback-based behavioral intervention over a 3-month period. Patients in the wait-list group participated in the treatment after the intervention group had completed the treatment. Results showed clear improvements regarding tinnitus annoyance, diary ratings of loudness, and feelings of controllability. Furthermore, changes in coping cognitions as well as changes in depressive symptoms were found. Improvements were maintained over a 6-month follow-up period in which medium-to-large effect sizes were observed. The treatment developed and investigated in this study is well accepted and leads to clear and stable improvements. Through demonstration of psychophysiological interrelationships, the treatment enables patients to change their somatic illness perceptions to a more psychosomatic point of view.