An interventional study of E-neurocognitive module in Bipolar Disorder, sponsored by Consorcio Centro de Investigación Biomédica en Red (CIBER). Completed at 1 site in Spain. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-02-07.
Sponsored by Consorcio Centro de Investigación Biomédica en Red (CIBER) · Not applicable, Interventional, and Treatment
Between 40% and 60% bipolar patients experience neurocognitive impairment not only during acute mood episodes but also during remission periods. These rates are quite similar to those reported as regards to functional impairment. In fact, it is estimated that only one third of patients achieve full social and occupational recovery and get back to their premorbid levels. Moreover, neurocognitive deficits, together with other clinical and sociodemographic variables are thought to contribute to functional impairment for bipolar disorder, similarly to that found in schizophrenia. Little is published with regard to neurocognitive remediation in bipolar disorder. The first open label study on bipolar disorder was published in 2010 with positive results. Recently, a multicenter randomized clinical trial coordinated showed efficacy of an innovative intervention at improving functioning and reducing disability of bipolar patients. There is a need of investigating novel and creative ways to work on cognitive deficits including new technologies in order to reduce costs and increasing benefits for patients. No study addressing computerized cognitive training in bipolar disorder has been developed so far. This project aims to test the efficacy of an e-neurocognitive module as an adjunct to functional remediation in bipolar patients.
This is a randomized clinical study, rater-blind, placebo-controlled stratified by age, sex and educational level to assess the efficacy of a new program, an adjunctive e-neurocognitive module, to functional remediation intervention. The primary outcome measure will be the improvement in global psychosocial functioning measured blindly as the mean change in score Functioning Assessment Short Test from baseline to endpoint. The sample will be composed by 132 euthymic bipolar (type I or II) patients who will be assessed at baseline regarding several clinical, functional and neuropsychological variables. Subsequently, the patients will consecutively start the functional remediation groups, once the group will be finished the patients will be randomly assigned (1:1) to two different groups. The experimental group (EG, 66 patients) will take part of a 12-week extension with a total of 36 hours training with the e-cognitive module tailored for bipolar patients whilst the control group (CG, 66 patients) will not receive any sort of add-on training just the recommendations from the therapists to train the same amount of time that the experimental group: twice per week a total of 3 hours with the material provided during the functional remediation group. All patients will keep on receiving standard psychiatric treatment according to the local treatment guidelines for the management of bipolar patients. At nine months, once the home training has been completed, all patients will be assessed again regarding several clinical, functional and neuropsychological variables. All patients will be assessed monthly regarding several clinical variables, including mood measurements (YMRS and HDRS). At 24 months from baseline, all measurements will be repeated to all patients. In total, three assessments will be conducted (baseline, post-intervention and at 2 years follow-up). The first active intervention that all patients will be receiving is the Functional Remediation Program:
* The Functional Remediation Program which consists of 21 weekly sessions, 90 minutes each. This intervention addresses neurocognitive issues such as attention, memory and executive functions but focuses even more on enhancing functioning in daily routine. The content of this intervention is based on ecological tasks to be performed in two settings, in the clinical but also at home. Patients were trained with exercises in memory, attention, problem solving and reasoning, multitasking and organization in order to improve their functional outcome. Most of the techniques were based on "paper and pencil" tasks and group activities.
After the randomization some patients will continue their training through an e-neurocognitive module specially adaptated for bipolar patients.
In the two groups pharmacological treatment will be prescribed according to the local treatment guidelines for the management of bipolar patients. Criteria for discontinuation during this study will be one or more of the following: 1) Missing more than five sessions during the Functional Remediation intervention 2) Hospitalization for any type of episode or clinical meaningful affective relapse 3) Withdrawal of consent.
1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.
This study's enrollment of 100 is above the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Consorcio Centro de Investigación Biomédica en Red (CIBER) is the lead sponsor of 18 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
E-neurocognitive module training.
Behavioral: E-neurocognitive module
The group will note receive any sort of add-on training, just the recommendations from the therapists.
The experimental group will take part of a 12-week extension with a total of 36 hours training with the e-neurocognitive module tailored for bipolar patients
Psychosocial functioning measured by Functioning Assessment Short Test
The scale is interviewer-administered, designed for the assessment of psychosocial functioning. The 24 items of the scale are divided among 6 specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time. Each individual item is scored from 0 to 3. The global score (0-72) is obtained when the scores of each item are added up. The higher the score, the more serious the difficulties.
Time frame: 15 days
Plan to share: No
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Consorcio Centro de Investigación Biomédica en Red (CIBER)