Functional Remediation for Bipolar Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment to Enhance Cognition in Bipolar Disorder

NCT01470781

Bipolar Disorder Psychosis

COMPLETED NA

Efficacy of an Innovative E-neurocognitive Module for Bipolar Disorder

NCT02481895

Bipolar Disorder

COMPLETED NA

A Trial of Functional Remediation in Patients With Bipolar Disorder

NCT04577508

Bipolar Disorder

UNKNOWN NA

Study Efficacy of Enhancing Cognitive Reserve in Patients With a First Bipolar Episode

NCT06081634

Bipolar Disorder

COMPLETED NA

Effects of an Integrative Psychological Program in Bipolar Disorder

NCT04031560

Bipolar Disorder

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bipolar Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Functional remediation

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.

Group Type EXPERIMENTAL

Functional remediation

Intervention Type BEHAVIORAL

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.

Psychoeducation

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.

Group Type ACTIVE_COMPARATOR

Psychoeducation

Intervention Type BEHAVIORAL

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.

Treatment as Usual

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

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type BEHAVIORAL

The patients will not receive any add-on psychosocial intervention. All patients will keep on receiving standard psychiatric treatment.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Functional remediation

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.

Intervention Type BEHAVIORAL

Psychoeducation

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.

Intervention Type BEHAVIORAL

Treatment as usual

The patients will not receive any add-on psychosocial intervention. All patients will keep on receiving standard psychiatric treatment.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No