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See detailStudy protocol for a multi-center RCT testing a group-based parenting intervention tailored to mothers with borderline personality disorder against a waiting control group (ProChild*-SP1).
Rosenbach, Charlotte; Heinrichs, Nina; Kumsta, Robert UL et al

in Trials (2022), 23(1), 589

BACKGROUND/AIMS: Borderline personality disorder (BPD) is a severe mental disorder characterized by an unstable sense of self, intense and rapidly changing affect, as well as impulsive and self ... [more ▼]

BACKGROUND/AIMS: Borderline personality disorder (BPD) is a severe mental disorder characterized by an unstable sense of self, intense and rapidly changing affect, as well as impulsive and self-destructive behaviors. Interpersonal relationships of individuals with BPD are characterized by marked instability, a lack of dependability, and quick changes between love and hate. For children of individuals with BPD, this can lead to permanent stress and attachment insecurity and an increased risk of adverse physical and mental health development. To reduce dysfunctional parenting and improve positive parenting, and in turn, to promote healthy child development, a group intervention for mothers with BPD was developed. This study aims to evaluate this first disorder-specific parenting intervention for BPD in a randomized controlled trial. METHOD: In a parallel-group, two-arm, randomized controlled trial, an initial N = 178 mothers diagnosed with BPD and their children aged 6 months to 6 years are assigned to either the parenting intervention or a waiting control group. If taking place, participants of both groups continue their regular treatment for BPD diagnosis (e.g., individual therapy, medication). The primary outcomes are changes in parenting from baseline (day 0) to post intervention (week 12) and follow-up (6 months after group intervention; month 9). The waiting control group can attend the group intervention at the end of all assessments. Participants allocated to the intervention group are expected to show improvement in their parenting and a reduction in child abuse potential. Maternal emotion regulation and mental distress are analyzed as secondary outcomes. DISCUSSION: Mothers with BPD may need tailored help when reporting difficulties raising their children. The first disorder-specific parenting intervention has been developed to close this gap. ProChild is part of a large government-supported consortium, which aims to investigate different aspects of abuse and maltreatment in childhood and adolescence. TRIAL REGISTRATION: ClinicalTrials.gov NCT04169048 . Registered on Nov 19, 2019. [less ▲]

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See detailA randomized controlled trial of an Internet-based emotion regulation intervention for sexual health: study protocol
Fischer, Vinicius Jobim; Andersson, Gerhard; Billieux, Joel et al

in Trials (2021), 22

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See detailCombined STN/SNr-DBS for the treatment of refractory gait disturbances in Parkinson's disease: study protocol for a randomized controlled trial.
Weiss, Daniel; Wachter, Tobias; Meisner, Christoph et al

in Trials (2011), 12

BACKGROUND: Severe gait disturbances in idiopathic Parkinson's disease (PD) are observed in up to 80% of all patients in advanced disease stages with important impact on quality of life. There is an unmet ... [more ▼]

BACKGROUND: Severe gait disturbances in idiopathic Parkinson's disease (PD) are observed in up to 80% of all patients in advanced disease stages with important impact on quality of life. There is an unmet need for further symptomatic therapeutic strategies, particularly as gait disturbances generally respond unfavourably to dopaminergic medication and conventional deep brain stimulation of the subthalamic nucleus in advanced disease stages. Recent pathophysiological research pointed to nigro-pontine networks entrained to locomotor integration. Stimulation of the pedunculopontine nucleus is currently under investigation, however, hitherto remains controversial. The substantia nigra pars reticulata (SNr)--entrained into integrative locomotor networks--is pathologically overactive in PD. High-frequent stimulation of the substantia nigra pars reticulata preferentially modulated axial symptoms and therefore is suggested as a novel therapeutic candidate target for neuromodulation of refractory gait disturbances in PD. METHODS: 12 patients with idiopathic Parkinson's disease and refractory gait disturbances under best individual subthalamic nucleus stimulation and dopaminergic medication will be enroled into this double-blind 2 x 2 cross-over clinical trial. The treatment consists of two different stimulation settings using (i) conventional stimulation of the subthalamic nucleus [STNmono] and (ii) combined stimulation of distant electrode contacts located in the subthalamic nucleus and caudal border zone of STN and substantia nigra pars reticulata [STN+SNr]. The primary outcome measure is the change of the cumulative 'axial score' (UPDRS II items '13-15' and UPRDS III items '27-31') at three weeks of constant stimulation in either condition. Secondary outcome measures include specific scores on freezing of gait, balance function, quality of life, non-motor symptoms, and neuropsychiatric symptoms. The aim of the present trial is to investigate the efficacy and safety of a three week constant combined stimulation on [STN+SNr] compared to [STNmono]. The results will clarify, whether stimulation on nigral contacts additional to subthalamic stimulation will improve therapeutic response of otherwise refractory gait disturbances in PD. TRIAL REGISTRATION: The trial was registered with the clinical trials register of http://www.clinicaltrials.gov (NCT01355835). [less ▲]

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