A Trial of Functional Remediation in Patients With Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Efficacy of Functional Remediation on Cognitive and Psychosocial Functioning in Patients With Bipolar Disorder: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04577508
• Other study ID #: NP 3976
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2021
• Est. completion date: June 2023

Study information

• Verified date: September 2020
• Source: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• Contact: Antonio Vita, Prof
• Phone: +39 0303995233
• Email: antonio.vita[@]unibs.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease

Intervention

Behavioral:
• 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.

Other:
• Treatment as usual
Standard care for bipolar disorders according to good clinical practice, including drug therapy and individual case management.

Locations

Country	Name	City	State
Italy	Department of Mental Health and Addiction Services	Brescia	BS

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Neurocognitive performance	Neurocognitive performance will be tested using a complete neuropsychological battery specifically developed for patients with bipolar disorder: the Brief Assessment of Cognition in Affective Disorders (BAC-A) (Keefe et al., 2014), Italian normative data (Rossetti et al. 2019)	Baseline to post-treatment (6 months)
Secondary	Neurocognitive performance	Neurocognitive performance will be tested using a complete neuropsychological battery specifically developed for patients with bipolar disorder: the Brief Assessment of Cognition in Affective Disorders (BAC-A) (Keefe et al., 2014), Italian normative data (Rossetti et al. 2019)	Baseline to follow-up (12 months)
Secondary	Socio-cognitive performance/Emotional processing	Social cognition will be evaluated using the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT), Italian version (Curci et al, 2003)	Baseline to post-treatment (6 months)
Secondary	Socio-cognitive performance/Emotional processing	Social cognition will be evaluated using the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT), Italian version (Curci et al, 2003)	Baseline to follow-up (12 months)
Secondary	Subthreshold manic symptoms	Manic symptoms will be evaluated using the Young Mania Rating Scale (Y-MRS) (Young et al, 1978). Euthymia will be defined by a score of Y-MRS <= 6 points.	Baseline to post-treatment (6 months)
Secondary	Subthreshold manic symptoms	Manic symptoms will be evaluated using the Young Mania Rating Scale (Y-MRS) (Young et al, 1978). Euthymia will be defined by a score of Y-MRS <= 6 points.	Baseline to follow-up (12 months)
Secondary	Subthreshold depressive symptoms	Depressive symptoms will be evaluated using the Hamilton Depression Rating Scale (HAM-D) (Hamilton et al, 1960). Euthymia will be defined by a score of HAM-D <= 8 points.	Baseline to post-treatment (6 months)
Secondary	Subthreshold depressive symptoms	Depressive symptoms will be evaluated using the Hamilton Depression Rating Scale (HAM-D) (Hamilton et al, 1960). Euthymia will be defined by a score of HAM-D <= 8 points.	Baseline to follow-up (12 months)