Bipolar DisorderNCT04577508
A Trial of Functional Remediation in Patients With Bipolar Disorder
A study testing Functional Remediation and Treatment as usual in people with Bipolar Disorder, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Functional Remediation and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2021to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Mental Health and Addiction Services
Brescia, BS, 25133
Vivian Accardo, Psy, +39 3474892946, v.accardo@unibs.it
About this study
Official title: Efficacy of Functional Remediation on Cognitive and Psychosocial Functioning in Patients With Bipolar Disorder: a Randomized Controlled Trial
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.
Read the 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
- Being tested
- Functional Remediation, Treatment as usual
- Keywords
- Bipolar Disorder, Psychosocial Functioning, Functional Remediation, Mood Disorder, Cognitive Enhancement, Cognitive Dysfunctions, Psychosocial interventions, Cognitive Remediation
- Medical subject headings
- Bipolar Disorder, Mood Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional RemediationBehavioural
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.
Treatment as usualOther
Standard care for bipolar disorders according to good clinical practice, including drug therapy and individual case management.
| Study group | Role | What they receive |
|---|---|---|
| Functional Remediation | Experimental | Functional Remediation Receives: Behavioral: Functional Remediation |
| Control | Other | Treatment as usual Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychosocial functioning
Functional outcome will be rated using the Functioning Assessment Short Test (FAST) - Italian Version (Barbato et al., 2013)
Measured: 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)
Measured: Baseline to follow-up (12 months)
Secondary outcomes (8)
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)
Measured: Baseline to post-treatment (6 months)
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)
Measured: Baseline to follow-up (12 months)
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)
Measured: Baseline to post-treatment (6 months)
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)
Measured: Baseline to follow-up (12 months)
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.
Measured: Baseline to post-treatment (6 months)
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.
Measured: Baseline to follow-up (12 months)
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.
Measured: Baseline to post-treatment (6 months)
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.
Measured: Baseline to follow-up (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study startJan 2021 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Vita, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577508
- Sponsor's protocol ID
- NP 3976
- Status last verified
- Sep 2020
- First submitted
- 30 Sep 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Functional Remediation on Cognitive and Psychosocial Functioning in Patients With Bipolar Disorder: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04577508
- Acronym / sponsor ID
- NP 3976
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, Psychosocial Functioning, Functional Remediation, Mood Disorder, Cognitive Enhancement, Cognitive Dysfunctions, Psychosocial interventions, Cognitive Remediation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| Functional Remediation | Experimental | Behavioral: Functional RemediationFunctional Remediation |
| Control | Other | Other: Treatment as usualTreatment as usual |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional RemediationFunctional 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. | Behavioural | Functional Remediation |
| Treatment as usualStandard care for bipolar disorders according to good clinical practice, including drug therapy and individual case management. | Other | Control |
Primary outcome
Psychosocial functioning
Time frame: Baseline to post-treatment (6 months)
Functional outcome will be rated using the Functioning Assessment Short Test (FAST) - Italian Version (Barbato et al., 2013)
Psychosocial functioning
Time frame: Baseline to follow-up (12 months)
Functional outcome will be rated using the Functioning Assessment Short Test (FAST) - Italian Version (Barbato et al., 2013)
8 secondary outcomes
Neurocognitive performance
Time frame: Baseline to post-treatment (6 months)
Neurocognitive performance
Time frame: Baseline to follow-up (12 months)
Socio-cognitive performance/Emotional processing
Time frame: Baseline to post-treatment (6 months)
Socio-cognitive performance/Emotional processing
Time frame: Baseline to follow-up (12 months)
Subthreshold manic symptoms
Time frame: Baseline to post-treatment (6 months)
Subthreshold manic symptoms
Time frame: Baseline to follow-up (12 months)
Subthreshold depressive symptoms
Time frame: Baseline to post-treatment (6 months)
Subthreshold depressive symptoms
Time frame: Baseline to follow-up (12 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Remediation and Treatment as usual in people with Bipolar Disorder, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Vita, Prof (+39 0303995233, antonio.vita@unibs.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychosocial functioning (time frame: Baseline to post-treatment (6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.