Clinical trial NCT04577508: A Trial of Functional Remediation in Patients With Bipolar Disorder
Official title: Efficacy of Functional Remediation on Cognitive and Psychosocial Functioning in Patients With Bipolar Disorder: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bipolar Disorder
Keywords: Bipolar Disorder
Psychosocial Functioning
Functional Remediation
Mood Disorder
Cognitive Enhancement
Cognitive Dysfunctions
Psychosocial interventions
Cognitive Remediation
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Psychosocial functioning
timeFrame: Baseline to post-treatment (6 months)
measure: Psychosocial functioning
timeFrame: Baseline to follow-up (12 months)
Secondary outcomes:
measure: Neurocognitive performance
timeFrame: Baseline to post-treatment (6 months)
measure: Neurocognitive performance
timeFrame: Baseline to follow-up (12 months)
measure: Socio-cognitive performance/Emotional processing
timeFrame: Baseline to post-treatment (6 months)
measure: Socio-cognitive performance/Emotional processing
timeFrame: Baseline to follow-up (12 months)
measure: Subthreshold manic symptoms
timeFrame: Baseline to post-treatment (6 months)
measure: Subthreshold manic symptoms
timeFrame: Baseline to follow-up (12 months)
measure: Subthreshold depressive symptoms
timeFrame: Baseline to post-treatment (6 months)
measure: Subthreshold depressive symptoms
timeFrame: Baseline to follow-up (12 months)
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Department of Mental Health and Addiction Services
state: BS
Study officials:
References: