The purpose of this project is to improve the clinical response and personal recovery of patients with treatment-resistant schizophrenia (TRS).
The Project aims to improve the efficacy of the first worldwide study of Deep Brain Stimulation (DBS) carried out in our hospital -PI12 / 00042: Deep Brain Stimulation in the treatment of refractory schizophrenia- through the implementation of a white matter tractography approach, which have demonstrated to improve efficacy in other DBS studies . Moreover, and in line with the National Strategy of Mental Health of the National Health System, this project aims to promote integrated and comprehensive care for patients with mental illness by multidisciplinary teams which includes family care, as we consider it is important to add to the DBS treatment program, a psychological intervention module based on the recovery model. Therefore, the main objectives of the present project are: i) to optimizethe efficacy and tolerability of DBS in TRS; ii) investigate whether the REFOCUS intervention improves the recovery of patients who are being treated with DBS. To this end, a double-blind, randomized, crossover clinical trial of DBS will be performed for 6 patients with TRS. Patients will be randomized to receive tractography-based target guidance DBS in the anterior cingulate cortex (ACC) or the nucleus accumbens (Nac). The 21 patient previously intervened with DBS (Affective disorders and TRS) and the ones included in this project, will enter into a psychological intervention phase, based on the REFOCUS model
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
6
The surgical electrode implanted in target 1 (ACC) or target 2 (NAcc) by a pulse generating device is "on".
The surgical electrode implanted in target 1 (ACC) or target 2 (NAcc) by a pulse generating device is "off".
Department of Psychiatry. Hospital Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Scale to assess changes in schizophrenia' symptoms
Time frame: Changes from baseline score to 1-3 weeks scores and to fortnightly scores until the end of trial (12 months)
Questionnaire about the Process of Recovery (QPR)
Scale to assess personal recovery changes
Time frame: Changes from baseline total score to 1-12 months total scores
Rosenberg Self-Esteem Scale (RSES)
Scale to assess a person's global self-esteem
Time frame: Changes from baseline total score to 12 months total scores
Herth Hope Index (HHI)
Scale to assess hope
Time frame: Changes from baseline total score to 12 months total scores
Internalized stigma of mental illness scale (ISMI)
Scale to assess insight
Time frame: Changes from baseline total score to 12 months total scores
Beck Cognitive Insight Scale (BCIS)
Scale to assess cognitive insight
Time frame: Changes from baseline total score to 12 months total scores
Personal Beliefs about Illness Questionnaire-Revised (PBIQ-R)
Scale to assess psychological reactions to psychosis
Time frame: Changes from baseline total score to 12 months total scores
Trail Making Test (TMT A & B)
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Scale to assess executive function
Time frame: Changes from baseline score to 12 months score.
Rey Auditory Verbal Learning Test (RAVLT)
Scale to assess short-term auditory-verbal memory
Time frame: Changes from baseline score to 12 months score.
F-A-S Test
Scale to assess verbal fluency
Time frame: Changes from baseline score to 12 months score.
Wisconsin Card Sorting Test (WCST)
Scale to assess cognitive flexibility and abstract reasoning
Time frame: Changes from baseline score to 12 months score.
Personal and Social Performance scale (PSP)
Scale to assess changes in functioning
Time frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
EuroQol 5 dimensions-5 levels (EQ-5D-5L)
Scales to asses the patient quality of life
Time frame: Changes from baseline score to 1-12 months scores
Client Satisfaction Questionnaire-8 (CSQ-8)
Scales to asses the satisfaction with the treatment
Time frame: Changes from baseline score to 12 months score.
Scale for the Assessment of Negative Symptoms (SANS)
Scales to assess negative symptoms of schizophrenia
Time frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Clinical Global Impression - Schizophrenia (CGI-SCH)
Scale to assess the severity of disorder and the degree of change in patients
Time frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Starkstein Apathy Scale (SAS)
Scale to assess apathy
Time frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Beck Depression Inventory (BDI)
Scale to assess depression
Time frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Beck Anxiety Inventory (BAI)
Scale to assess anxiety
Time frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Global Assessment of Functioning (GAF)
Scale to rate how serious a mental disorder may be
Time frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Side Effect Rating Scale (UKU)
Scale to rate side effects
Time frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores