A Trial of Functional Remediation in Patients With Bipolar Disorder

NCT04577508 | Unknown

• 1 other identifier: NP 3976
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder; Psychosocial Functioning; Functional Remediation; Mood Disorder; Cognitive Enhancement; Cognitive Dysfunctions; Psychosocial interventions; Cognitive Remediation

Outcome Measures

Primary Outcomes (2)

• Psychosocial functioning

  Functional outcome will be rated using the Functioning Assessment Short Test (FAST) - Italian Version (Barbato et al., 2013)

  Baseline to post-treatment (6 months)

• Psychosocial functioning

  Functional outcome will be rated using the Functioning Assessment Short Test (FAST) - Italian Version (Barbato et al., 2013)

  Baseline to follow-up (12 months)

Secondary Outcomes (8)

• Neurocognitive performance

  Baseline to post-treatment (6 months)

• Neurocognitive performance

  Baseline to follow-up (12 months)

• Socio-cognitive performance/Emotional processing

  Baseline to post-treatment (6 months)

• Socio-cognitive performance/Emotional processing

  Baseline to follow-up (12 months)

• Subthreshold manic symptoms

  Baseline to post-treatment (6 months)

Study Arms (2)

Functional Remediation

EXPERIMENTAL

Functional Remediation

Behavioral: Functional Remediation

Control

OTHER

Treatment as usual

Other: Treatment as usual

Interventions

Functional Remediation 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.

Functional Remediation

Treatment as usual OTHER

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

Control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead

Study Sites (1)

Department of Mental Health and Addiction Services

Brescia, BS, 25133, Italy

Location

MeSH Terms

Conditions

Bipolar Disorder; Mood Disorders; Cognitive Dysfunction

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Central Study Contacts

Antonio Vita, Prof

CONTACT

+39 0303995233; antonio.vita@unibs.it

Vivian Accardo, Psy

CONTACT

+39 3474892946; v.accardo@unibs.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Department of Mental Health and Addiction Services

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 8, 2020
• Study Start: January 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: October 8, 2020

Record last verified: 2020-09

Locations

IT (1)