Functional Remediation for Bipolar Disorder

Study Overview
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Brief Summary
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Bipolar disorder is a severe, chronic and recurrent illness, that affects nearly the 5% of the population. Recent research point at the relevance and persistence of cognitive dysfunctions in bipolar patients even beyond the acute phases, although cognitive impairment has been classically associated with schizophrenia and not bipolar disorder. Current findings suggest that some intervention is needed in order to improve not only affective symptoms but also cognitive dysfunctions, so that patients could benefit from cognitive remediation techniques to improve cognitive impairment and the functional outcome. There is no previous research on the efficacy of cognitive remediation programs on bipolar disorder.

Detailed Description
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The method consists of a randomized clinical trial with 3 arms: 1) one group (n=66) will receive a cognitive rehabilitation program + pharmacological treatment, 2) another group (n=66) will receive a psychoeducation program + pharmacological treatment, and 3) a control group (n=66) will only receive pharmacological treatment. A psychopathological, neuropsychological and functional assessment will be administered pre and post-intervention and a 12-month follow-up to assess the long term effects of the intervention.

Official Title
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Comparative Efficacy of Two Psychosocial Strategies of Intervention (Neurocognitive vs Psychoeducative) as add-on Therapy Versus Treatment as Usual in Bipolar Disorder

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Behavioral: Functional remediation
* Behavioral: Psychoeducation
* Behavioral: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients Diagnosis of bipolar disorder type I or II, according to DSM-IV-TR 4ª Ed criteria Adult patients, aged between 18 and 55 years old Euthymic (YMRS < 6, HDRS < 8) for at least three months prior to study entry. Signed inform consent Severe or moderate functional impairment (FAST > 18) Exclusion Criteria: IQ < 85 Neurological illness Present diagnosis of substance abuse or dependence according to DSM-IV criteria the last three months Significant medical illness considered as severe by the study that may interfere with assessments having been enrolled in any kind of cognitive rehabilitation intervention the last two years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Functional remediation<br>Patients assigned to the experimental treatment will receive standard psychiatric care and will be enrolled in the neurocognitive intervention program composed of 21 sessions of 90 minutes, each aimed at improving the following cognitive domains: attention, memory and executive functions and psychosocial functioning. The program will be performed in an 8-to-10 patient group conducted by 2 experienced neuropsychologists. with previous experience with bipolar patients (at least 3 years) and specific training on patients' group management. | Behavioral: Functional remediation<br>* The functional remediation program is composed of 21 weekly sessions of 90 minutes, each aimed at improving the following cognitive domains: attention, memory and executive functions and psychosocial functioning. The program will be performed in an 12- to 15-patient group conducted by 2 experienced neuropsychologists with previous experience with bipolar patients and specific training on patients' group management.<br>|
| Active Comparator: Psychoeducation<br>The group psychoeducation is a tested (Colom et al, 2003) and manualized intervention (Vieta and Colom, 2006) consisting on 21 sessions of 90 minutes, aimed at improving 4 main issues: illness awareness, treatment adherence, early detection of prodromal symptoms and recurrences and lifestyle regularity. The program will be performed in an 8-10 patient group conducted by 2 experienced psychologists with previous experience with bipolar patients and specific training on patients' group management. The structure of each session consists of a 30 to 40 minute speech on the topic of the day, followed by an exercise related to the issue (eg. drawing a life chart, writing a list of potential triggering factors) and a discussion. | Behavioral: Psychoeducation<br>* Group psychoeducation is a tested and manualized intervention consisting of 21 weekly sessions of 90 minutes aimed at improving 4 main issues: illness awareness, treatment adherence, early detection of prodromal symptoms and recurrences, and lifestyle regularity.<br>|
| Active Comparator: Treatment as Usual<br>This arm will not receive any sort of add-on psychosocial intervention. All patients will keep on receiving standard psychiatric treatment. | Behavioral: Treatment as usual<br>* The patients will not receive any add-on psychosocial intervention. All patients will keep on receiving standard psychiatric treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment Short Test (FAST) | The FAST is a valid and reliable instrument, easy to apply which requires a short period of time to administer. Evaluates functioning taking into account the last 15 days. It was developed for the clinical evaluation of the main difficulties presented by psychiatric patients, and has been validated in several languages for patients with bipolar disorder. The FAST scale consists of 24 items which allow the assessment of six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time. | Baseline | 
| Functional Assessment Short Test (FAST) | The FAST is a valid and reliable instrument, easy to apply which requires a short period of time to administer. Evaluates functioning taking into account the last 15 days. It was developed for the clinical evaluation of the main difficulties presented by psychiatric patients, and has been validated in several languages for patients with bipolar disorder. The FAST scale consists of 24 items which allow the assessment of six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time. | 6 months | 
| Functional Assessment Short Test (FAST) | The FAST is a valid and reliable instrument, easy to apply which requires a short period of time to administer. Evaluates functioning taking into account the last 15 days. It was developed for the clinical evaluation of the main difficulties presented by psychiatric patients, and has been validated in several languages for patients with bipolar disorder. The FAST scale consists of 24 items which allow the assessment of six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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functional remediation, psychoeducation, neurocognition