Original Title: Evaluación de la eficacia de técnicas psicosociales (rehabilitación cognitiva vs psicoeducación) como tratamiento adicional al tratamiento farmacológico en trastorno bipolar

Authors' objectives: Primary Endpoints 1. To review the efficacy of cognitive rehabilitation interventions in bipolar patients. 2. To determine the evolution of functional adaptation and cognitive dysfunctions in a broad sample of euthymic bipolar patients (pre- and post-intervention) and the differences between a specific intervention targeting cognitive dysfunction (neurocognitive intervention) and a non-specific (psychoeducational) intervention with standard treatment (TAU). 3. To evaluate whether application of a neurocognitive intervention programme and a psychoeducational intervention programme has a beneficial effect on the clinical progress of the disease (relapses, hospitalisation and suicidal behaviour) and the functioning of the bipolar patient by way of clinical follow-up and specific questionnaires compared with a control group. Secondary Endpoints 1. To study the cost of both types of intervention and compare with the cost of the control group. In addition, to analyse the cost-benefit differences for both interventions. 2. Finally, to determine the profile of patients who improve with each intervention (improvement of at least 20% on the Fast scale).

Authors' results and conclusions: A total of 102 patients with BD I and II were included. There were no differences between the three groups as regards sociodemographic and clinical variables at baseline, except for the diagnosis variable, as most patients were BD I. In cognitive terms, significant differences were found in the vocabulary, IQ estimation, working memory and immediate recall memory tests, and it should be noted that all patients had an average functioning in all tests except the reverse digits test, which evaluates working memory, where they had a below average score. Patients exhibited very poor functionality at the initial evaluation, improving throughout follow-up, especially those from the rehabilitation group (U=132; p=0.001). In addition, we found that the variables associated with poor functionality are a higher incidence of relapse during follow-up (B=4.273; p= 0.042), poor adherence (B=15.482; p=0.002), depressive symptomatology (B=0.767; p=0.021), a worse estimated IQ at 6 months (B=-0.113; p=0.035), worse performance in the digits test (B=0.651; p=0.023), and worse ability to emit an immediate recall (B=-1.003; p=0.005). Finally, we analysed the characteristics of those patients who exhibited an improvement in functionality of at least 20% and found that males (X2: 7.643; p=0.006), patients with bipolar disorder type I (X2: 4.907; p=0.027), cannabis users (X2: 10.009; p=0.002), patients with lower depression scores (U: 217.5; p=0.002) and those presenting greater manic symptomatology (U=240; p=0.001) exhibited the most marked improvements. CONCLUSIOMNS The most relevant finding is the ability of the different types of treatment to intervene in different areas of the life of subjects affected by a mental disorder. Thus, we found that the TAU group had the highest percentage of relapses (76.5%), followed by the rehabilitation (64.7%) and psychoeducational groups (35.3%). However, these differences are clinical rather than being statistically significant. It should also be noted that psychoeducational treatment also has the lowest number of treatment abandonments (8.8%), followed by standard treatment (11.8%) and rehabilitation (35.3%). We found that rehabilitation is useful as regards improving the functionality of patients throughout follow-up. Another recommendation that can be extracted from this research is that the functionality of a particular type of patient improves throughout the year, with these patients tending to exhibit less depressive and manic symptomatology, better treatment adherence and good medication adherence. In addition, we found that recreational drug use does not prevent such patients from functioning. A better understanding of improvement patterns may serve as a predictive model that allows specific interventions to be adopted for each patient. Consequently, our recommendation in light of the results above is the implementation of this type of therapy in our setting. In addition, given the profile of patients, such therapies could be applied specifically depending on the most severe problem exhibited by each patient. Indeed, Scott (2012) recommends that interventions should be personalised and selected on the basis of the stage in which patients find themselves.

Authors' methods: The method basically comprises a randomised clinical trial with three arms: 1) an experimental group of 34 bipolar patients who will follow a cognitive rehabilitation programme in addition to cognitive rehabilitation, 2) a group that will receive a psychoeducational programme together with pharmacological treatment (n=34), and 3) a control group that will receive pharmacological treatment only (n=34). Randomisation will be performed stratifying by age, sex and educational level using the Random allocation software program. The intervention will last for six months, with one weekly 90-minute session. A psychopathological and neuropsychological evaluation will be carried out, and general functioning will be evaluated, for all patients pre- and post-intervention and at 12 months to evaluate the long-term effects of the intervention. The psychoeducational guide has been created on the basis of a review of the PUBMEd, MEDLINE and OVID databases to date.

Project Status: Completed

Year Published: 2015

URL for published report: https://www.ogasun.ejgv.euskadi.eus/r51-catpub/es/k75aWebPublicacionesWar/k75aObtenerPublicacionDigitalServlet?R01HNoPortal=true&N_LIBR=051620&N_EDIC=0001&C_IDIOM=es&FORMATO=.pdf

English language abstract: An English language summary is available

Publication Type: Other

Country: Spain

Organisation Name: Basque Office for Health Technology Assessment

Contact Address: C/ Donostia – San Sebastián, 1 (Edificio Lakua II, 4ª planta) 01010 Vitoria - Gasteiz

Contact Name: Lorea Galnares-Cordero

Contact Email: lgalnares@bioef.eus

Copyright: <p>Osteba (Basque Office for Health Technology Assessment) Health Department of the Basque Government</p>