RESUMEN
INTRODUCTION: Patients with bipolar disorder (BD) are frequently exposed to traumatic events which worsen disease course, but this study is the first multicentre randomised controlled trial to test the efficacy of a trauma-focused adjunctive psychotherapy in reducing BD affective relapse rates. MATERIALS AND METHODS: This multicentre randomised controlled trial included 77 patients with BD and current trauma-related symptoms. Participants were randomised to either 20 sessions of trauma-focused Eye Movement Desensitization and Reprocessing (EMDR) therapy for BD, or 20 sessions of supportive therapy (ST). The primary outcome was relapse rates over 24-months, and secondary outcomes were improvements in affective and trauma symptoms, general functioning, and cognitive impairment, assessed at baseline, post-treatment, and at 12- and 24-month follow-up. The trial was registered prior to starting enrolment in clinical trials (NCT02634372) and carried out in accordance with CONSORT guidelines. RESULTS: There was no significant difference between treatment conditions in terms of relapse rates either with or without hospitalisation. EMDR was significantly superior to ST at the 12-month follow up in terms of reducing depressive symptoms (p=0.0006, d=0.969), manic symptoms (p=0.027, d=0.513), and improving functioning (p=0.038, d=0.486). There was no significant difference in dropout between treatment arms. CONCLUSIONS: Although the primary efficacy criterion was not met in the current study, trauma-focused EMDR was superior to ST in reducing of affective symptoms and improvement of functioning, with benefits maintained at six months following the end of treatment. Both EMDR and ST reduced trauma symptoms as compared to baseline, possibly due to a shared benefit of psychotherapy. Importantly, focusing on traumatic events did not increase relapses or dropouts, suggesting psychological trauma can safely be addressed in a BD population using this protocol.
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Currently, one of the main objectives of human-animal interaction research is to demonstrate the benefits of animal assisted therapy (AAT) for specific profiles of patients or participants. The aim of this study is to assess the effect of an AAT program as an adjunct to a conventional 6-month psychosocial rehabilitation program for people with schizophrenia. Our hypothesis is that the inclusion of AAT into psychosocial rehabilitation would contribute positively to the impact of the overall program on symptomology and quality of life, and that AAT would be a positive experience for patients. To test these hypotheses, we compared pre-program with post-program scores for the Positive and Negative Syndrome Scale (PANSS) and the EuroQoL-5 dimensions questionnaire (EuroQol-5D), pre-session with post-session salivary cortisol and alpha-amylase for the last four AAT sessions, and adherence rates between different elements of the program. We conducted a randomized, controlled study in a psychiatric care center in Spain. Twenty-two institutionalized patients with chronic schizophrenia completed the 6-month rehabilitation program, which included individual psychotherapy, group therapy, a functional program (intended to improve daily functioning), a community program (intended to facilitate community reintegration) and a family program. Each member of the control group (n = 8) participated in one activity from a range of therapeutic activities that were part of the functional program. In place of this functional program activity, the AAT-treatment group (n = 14) participated in twice-weekly 1-h sessions of AAT. All participants received the same weekly total number of hours of rehabilitation. At the end of the program, both groups (control and AAT-treatment) showed significant improvements in positive and overall symptomatology, as measured with PANSS, but only the AAT-treatment group showed a significant improvement in negative symptomatology. Adherence to the AAT-treatment was significantly higher than overall adherence to the control group's functional rehabilitation activities. Cortisol level was significantly reduced after participating in an AAT session, which could indicate that interaction with the therapy dogs reduced stress. In conclusion, the results of this small-scale RCT suggest that AAT could be considered a useful adjunct to conventional psychosocial rehabilitation for people with schizophrenia.