Functional Remediation for Bipolar Disorder

Centro de Investigación Biomédica en Red de Salud Mental

Status: Completed

Conditions: Bipolar Disorder

Treatments: Behavioral: Treatment as usual; Behavioral: Functional remediation; Behavioral: Psychoeducation

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01370668

PI080180 (Other Grant/Funding Number)

PI08/90094

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 198 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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198 participants in 3 patient groups

Functional remediation

Experimental group

Description:

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.

Treatment:

Behavioral: Functional remediation

Psychoeducation

Active Comparator group

Description:

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.

Treatment:

Behavioral: Psychoeducation

Treatment as Usual

Active Comparator group

Description:

This arm will not receive any sort of add-on psychosocial intervention. All patients will keep on receiving standard psychiatric treatment.

Treatment:

Behavioral: Treatment as usual