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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| On-Stimulation | Active Comparator | Disease condition is assessed with stimulation turned "on" |
|
| Off-Stimulation | Placebo Comparator | Disease condition is assessed with stimulation turned "off" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| On-Stimulation | Device | The surgical electrode implanted in target 1 (ACC) or target 2 (NAcc) by a pulse generating device is "on". |
|
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Syndrome Scale for Schizophrenia (PANSS) | Scale to assess changes in schizophrenia' symptoms | Changes from baseline score to 1-3 weeks scores and to fortnightly scores until the end of trial (12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire about the Process of Recovery (QPR) | Scale to assess personal recovery changes | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iluminada Corripio, PhD | Department of Psychiatry. Hospital Santa Creu i Sant Pau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry. Hospital Santa Creu i Sant Pau | Barcelona | Barcelona | Spain |
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| ID | Term |
|---|---|
| D000090663 | Schizophrenia, Treatment-Resistant |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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A clinical trial with four periods will be performed: pre-treatment, Intervention and follow-up, Cross-over period, and Recoveryoriented intervention.
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| Off-Stimulation | Device | The surgical electrode implanted in target 1 (ACC) or target 2 (NAcc) by a pulse generating device is "off". |
|
| Changes from baseline total score to 12 months total scores |
| Herth Hope Index (HHI) | Scale to assess hope | Changes from baseline total score to 12 months total scores |
| Internalized stigma of mental illness scale (ISMI) | Scale to assess insight | Changes from baseline total score to 12 months total scores |
| Beck Cognitive Insight Scale (BCIS) | Scale to assess cognitive insight | 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 | Changes from baseline total score to 12 months total scores |
| Trail Making Test (TMT A & B) | Scale to assess executive function | Changes from baseline score to 12 months score. |
| Rey Auditory Verbal Learning Test (RAVLT) | Scale to assess short-term auditory-verbal memory | Changes from baseline score to 12 months score. |
| F-A-S Test | Scale to assess verbal fluency | Changes from baseline score to 12 months score. |
| Wisconsin Card Sorting Test (WCST) | Scale to assess cognitive flexibility and abstract reasoning | Changes from baseline score to 12 months score. |
| Personal and Social Performance scale (PSP) | Scale to assess changes in functioning | 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 | Changes from baseline score to 1-12 months scores |
| Client Satisfaction Questionnaire-8 (CSQ-8) | Scales to asses the satisfaction with the treatment | Changes from baseline score to 12 months score. |
| Scale for the Assessment of Negative Symptoms (SANS) | Scales to assess negative symptoms of schizophrenia | 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 | Changes from baseline score to 1-3 weeks scores and to 1-12 months scores |
| Starkstein Apathy Scale (SAS) | Scale to assess apathy | Changes from baseline score to 1-3 weeks scores and to 1-12 months scores |
| Beck Depression Inventory (BDI) | Scale to assess depression | Changes from baseline score to 1-3 weeks scores and to 1-12 months scores |
| Beck Anxiety Inventory (BAI) | Scale to assess anxiety | 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 | 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 | Changes from baseline score to 1-3 weeks scores and to 1-12 months scores |