The effectiveness of ritanserin, a selective 5-HT2 and 5-HT1c antagonist, in reducing negative symptoms in schizophrenia was investigated in a double-blind, placebo-controlled trial. Trial treatment was added to a stable neuroleptic treatment in 33 schizophrenic patients with predominantly negative symptoms. Ritanserin reduced the negative symptoms, as measured with the SANS. The main reduction was for the items facial expression, global affective flattening, and relationships with friends and peers. Also a reduction in total BPRS score was found, which approached statistical significance. Significant reductions were observed for the BPRS items emotional withdrawal and depressive mood. Ritanserin or other drugs blocking 5-HT2 and/or 5-HT1c receptors could be important in reducing specific symptoms in schizophrenic patients.
Background
In blended therapy, face-to-face psychotherapy and Internet-based interventions are combined. Blended therapy may be advantageous for patients and psychotherapists. However, most blended interventions focus on cognitive behavioral therapy or single disorders, making them less suitable for routine care settings.
Methods
In a randomized controlled trial, we will compare blended therapy and face-to-face therapy in routine care. We intend to randomize 1152 patients nested in 231 psychotherapists in a 1:1 ratio. Patients in the blended therapy group will receive access to a therapeutic online intervention (TONI). TONI contains 12 transdiagnostic online modules suited for psychodynamic, cognitive behavioral, and systemic therapy. Psychotherapists decide which modules to assign and how to integrate TONI components into the psychotherapeutic process to tailor treatment to their patients’ specific needs. We will assess patients at baseline, 6 weeks, 12 weeks, and 6 months. Patients enrolled early in the trial will also complete assessments at 12 months. The primary outcomes are depression and anxiety at 6-month post-randomization, as measured by PHQ-8 and GAD-7. The secondary outcomes include satisfaction with life, level of functioning, personality traits and functioning, eating pathology, sexual problems, alcohol/drug use, satisfaction with treatment, negative effects, and mental health care utilization. In addition, we will collect several potential moderators and mediators, including therapeutic alliance, agency, and self-efficacy. Psychotherapists will also report on changes in symptom severity and therapeutic alliance. Qualitative interviews with psychotherapists and patients will shed light on the barriers and benefits of the blended intervention. Furthermore, we will assess significant others of enrolled patients in a sub-study.
Discussion
The integration of online modules which use a common therapeutic language and address therapeutic principles shared across therapeutic approaches into regular psychotherapy has the potential to improve the effectiveness of psychotherapy and transfer it into everyday life as well help save therapists’ resources and close treatment gaps. A modular and transdiagnostic setup of the blended intervention also enables psychotherapists to tailor their treatment optimally to the needs of their patients.
Trial registration
German Clinical Trials Register (DRKS) DRKS00028536. Registered on 07.06.2022.
In a double-blind trial, 22 patients treated with 5 mg b.i.d. of the selective serotonin-S2 antagonist ritanserin for 4 weeks were compared with 26 patients treated with placebo for generalized anxiety disorder (DSM 111: 300.02).Symptoms were assessed using the Hamilton Anxiety Rating Scale (HARS) and the Visual Analog Mood Rating Scale (Norris, Bond and Lader). Patients were further evaluated by means of a clinical global impression.At the end of the treatment ritanserin was significantly superior to placebo in its effect on the psychic cluster of the HARS, especially for the items insomnia (already after 1 week of treatment) tension and depressed mood. According to the Mood Rating Scale, the ritanserin-treated patients rated themselves as calmer, more energetic and more relaxed. This significant symptomatic improvement with ritanserin was confirmed by the clinical global impression. As only one side-effect was reported in the ritanserin group versus five in the placebo group, the results suggest that ritanserin provides a novel well-tolerated therapy for outpatients suffering from generalized anxiety disorder.
Based on the current evidence and clinical expertise the NDMG recommends psychotherapy alone or in combination with pharmacotherapy to treat most of these depressive patient groups. Evidence gaps were identified, which highlight the need for further research.
IntroductionWhereas the efficacy of cognitive-behavioural therapy has been demonstrated for a variety of mental disorders, there is still need for improvement, especially regarding less prevalent or more severe disorders. Recently, metacognitive interventions have been developed and are now available for a variety of diagnoses. Still, a systematic review investigating the effectiveness of different metacognitive interventions for various mental disorders is missing.Methods and analysisRandomised controlled trials (RCTs), cross-over and cluster RCTs and non-randomised controlled trials on metacognitive interventions (ie, metacognitive therapy, metacognitive training, others) in adults with any mental disorder will be included. As comparators, another psychological or pharmacological treatment, a combined psychological and pharmacological treatment, treatment as usual or no active treatment are eligible. Outcomes refer to efficacy and acceptability of metacognitive interventions.Ethics and disseminationIn light of the popularity of metacognitive interventions, the systematic review will provide researchers, clinicians and patients with substantial information on the intervention’s effectiveness across different mental disorders. Results will be published in peer-reviewed journals and disseminated through a patient workshop.
Psychotherapy alone or in combination with pharmacotherapy was shown to be an effective treatment option. Psychotherapy represents a key element in the treatment of depressive disorders.
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