A Trial of Functional Remediation in Patients With Bipolar Disorder

NCT ID: NCT04577508

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2023-06-30

Brief Summary

In the last decade several evidences show that cognitive impairment is a major feature of bipolar disorder (BD), that is strongly associated with patients' functional outcome. The most affected cognitive domains in BD are attention, memory and executive functions. BD represents a mental illness of considerable therapeutic complexity and the fight against cognitive and functional deterioration have contributed to increase the interest in the development of specific therapeutic strategies.There is the need of new non-pharmacological interventions in BD in order to improve not only affective symptoms, but also cognitive dysfunctions, with the final goal to achieve full functional recovery. The present study is focused on Functional Remediation (FR), a novel group intervention created by the Bipolar Disorder Unit of the Hospital Clinic of Barcelona and designed specifically for bipolar patients, based on a neuro-cognitive-behavioural approach. It involves neurocognitive and psychoeducation techniques (21 weekly sessions). The present study aims to assess FR efficacy in improving cognitive deficits and psychosocial functioning in a sample of euthymic patients with BD, compared to standard treatment (TAU). This is a randomized and rater-blind trial, involving 54 adult out-patients diagnosed with BD I or II (DSM-5 criteria) and clinically stable for at least two months. Patients will be assessed at baseline, post-treatment and 6-months follow-up, on validated cognitive, clinical and functional rating scales. The main result expected is that patients receiving FR will show better cognitive and psychosocial performance, further confirming the preliminary evidence on the utility of FR as an element of standard care for BD patients.

Detailed Description

The main objective of this randomized, rater-blind controlled trial is to evaluate the efficacy of Functional Remediation (FR) in improving functional, clinical and cognitive outcomes in euthymic and clinically stable patients with Bipolar Disorder.

FR is a novel group-based intervention, based on a neurocognitive-behavioural approach, making use of ecological techniques, specifically developed for patients with Bipolar Disorder and aimed at restoring psychosocial functioning in this population.

The study will involve subjects recruited from outpatient clinics (residential or semi-residential care) within the Department of Mental Health and Addiction Services of ASST Spedali Civili, Brescia, Italy.

Study participants will be assigned via central randomization to either FR or treatment as usual, the latter consisting of evidence-based drug treatment and case management.

Pharmacological treatment will be maintained stable during the course of the trial, but no restriction will be applied in terms of access to evidence-based non-pharmacological interventions.

Efficacy of the study intervention (lasting 6 months) will be assessed at post-treatment, and later investigated at 6-months follow-up.

The study will be conducted in accordance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice. It will take place within an experimental project related to the "PhD Course in Biomedical Sciences and Translational Medicine", curriculum "Neuroscience" of the University of Brescia, Italy.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Functional Remediation

Functional Remediation

Group Type: EXPERIMENTAL

Functional Remediation

Intervention Type: BEHAVIORAL

Functional Remediation is a manualized, group-based psychosocial intervention built on a neurocognitive-behavioural approach, involving modeling techniques, role-playing tasks, self-instruction, positive reinforcement and metacognitive cues (Vieta E et al, Cambridge University Press, 2014). It consists of 21 90-min weekly sessions, in which a trained therapist and co-therapist work with 10-12 patients: the first 3 sessions are dedicated to psychoeducation on neurocognitive deficits; then 13 sessions of neurocognitive training sequentially target attention, memory and executive functions domains, comprising exercises carried out individually, in pairs or in small groups; the last 5 sessions focus on skills training (communication, interpersonal relationships, autonomy, stress management). Content of the sessions involves ecological tasks adapted to real-world situations, and to-be-performed in two contexts (clinical and daily). Homework is assigned, collected and discussed each time.

Control

Treatment as usual

Group Type: OTHER

Treatment as usual

Intervention Type: OTHER

Standard care for bipolar disorders according to good clinical practice, including drug therapy and individual case management.

Interventions

Functional Remediation

Functional Remediation is a manualized, group-based psychosocial intervention built on a neurocognitive-behavioural approach, involving modeling techniques, role-playing tasks, self-instruction, positive reinforcement and metacognitive cues (Vieta E et al, Cambridge University Press, 2014). It consists of 21 90-min weekly sessions, in which a trained therapist and co-therapist work with 10-12 patients: the first 3 sessions are dedicated to psychoeducation on neurocognitive deficits; then 13 sessions of neurocognitive training sequentially target attention, memory and executive functions domains, comprising exercises carried out individually, in pairs or in small groups; the last 5 sessions focus on skills training (communication, interpersonal relationships, autonomy, stress management). Content of the sessions involves ecological tasks adapted to real-world situations, and to-be-performed in two contexts (clinical and daily). Homework is assigned, collected and discussed each time.

Intervention Type: BEHAVIORAL

Treatment as usual

Standard care for bipolar disorders according to good clinical practice, including drug therapy and individual case management.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with a clinical diagnosis of Bipolar Disorder, type I or II, as referred from treating psychiatrist, confirmed at recruitment using the Structured Clinical Interview for Disorder for DSM-5, Clinical Version (SCID-5-CV);
• Clinically stable (in euthymic phase, defined as Y-MRS <= 6 points + HAM-D <= 8 points) for at least 2 months;
• Aged from 18 to 55 years, with no restriction in terms of gender or ethnicity
• With a minimum education level of 8 years;
• Fluent in Italian language;
• Giving written informed consent to study participation.

Exclusion Criteria

• Intellectual disability (according to DSM-5 criteria);
• Any medical condition that may affect neuropsychological performance (such as neurological diseases);
• Any comorbid psychiatric condition (including current alcohol and/or drug abuse - up to 3 months before screening)
• Pregnancy;
• Inability to provide informed consent/ withdrawal of consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

OTHER

Sponsor Role: lead

Responsible Party

Antonio Vita

Head Department of Mental Health and Addiction Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Mental Health and Addiction Services

Brescia, BS, Italy

Countries

Italy

Central Contacts

Antonio Vita, Prof

Role: CONTACT

antonio.vita@unibs.it

+39 0303995233

Vivian Accardo, Psy

Role: CONTACT

v.accardo@unibs.it

+39 3474892946

Facility Contacts

Vivian Accardo, Psy

Role: primary

v.accardo@unibs.it

+39 3474892946

Other Identifiers

NP 3976

Identifier Type: -

Identifier Source: org_study_id