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.
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