Bipolar DisorderNCT06081634
Study Efficacy of Enhancing Cognitive Reserve in Patients With a First Bipolar Episode
A study testing Enhancing cognitive reserve and Treatment as Usual in people with Bipolar Disorder, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
This study aims to adapt and apply a psychological program aimed at improving cognitive reserve (CR) in bipolar patients who have recently presented a first episode of the illness. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Enhancing cognitive reserve and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2019to 30 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients between 18 and 40 years of age whose disease onset (first episode) is within the last 5 years.
- Fulfill diagnostic criteria for bipolar disorder (type I or type II) or schizoaffective disorder, bipolar type, according to the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association (DSM-5) based on a semi-structured clinical interview.
- Patients in clinical remission or partial remission at the time of assessment, defined as scores ≤ 10 on the Young Mania Rating Scale (YMRS) (Young, 1978) and ≤ 14 points on the Hamilton Depression Rating Scale (HAMD) (Hamilton, 1960).
- Signed informed consent to participate in the study.
Who cannot join
- Estimated IQ less than 85.
- Any medical condition that may affect neuropsychological performance (such as neurological diseases).
- Presence of any comorbid psychiatric condition (except substance use/abuse).
- Patients who have received any type of psychological intervention in the 6 months prior to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Efficacy of a Psychological Approach for the Enhancement of Cognitive Reserve in a Bipolar Population With a Recent First Episode
This study aims to adapt and apply a psychological program aimed at improving cognitive reserve (CR) in bipolar patients who have recently presented a first episode of the illness. The purpose of this project is to test both the effectiveness of the psychological intervention as well as the stability of the obtained results after nine months of follow-up. One-hundred and twenty patients (60 patients each centre) will be recruited and assessed with clinical, functioning, quality of life, neuropsychological and RC assessment tools. Then, participants will be randomly assigned to two different conditions: the experimental one, consisting in the implementation of the psychological intervention aiming at improving CR (n=60), and the control one, in which the usual pharmacological treatment will be carried on (n=60). Once the psychological intervention has finished (3 months) re-assessment of all the explored variables at baseline will be performed. Finally, after 12 months from the baseline visit, a re-assessment of all the participants in the study will be carried out to verify that post-intervention obtained results remain stable throughout the complete follow-up period. The investigators hypothesized that patients with a recent first episode who have undergone the intervention program will improve their CR as well as measures related to the severity of the difficulties observed at baseline concerning clinical, functioning, quality of life and neurocognitive performance. A second hypotheses is that all these changes will remain stable after nine month follow-up.
- Conditions
- Bipolar Disorder
- Being tested
- Enhancing cognitive reserve, Treatment as Usual
- Keywords
- Cognitive reserve
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhancing cognitive reserveBehavioural
Intervention in group format (6-8 patients) consisting of 12 weekly sessions, each lasting approximately 60 minutes. The aim of this intervention is to offer a series of strategies to increase academic and/or work achievements, leisure and free time activities, as well as an improvement in the level of neurocognitive functioning. Most of the tasks to be carried out are based on the use of pencil and paper with audiovisual support. Technological resources such as the use of the Internet and some telephone applications will also be used in some sessions. For those sessions in which the practice of mindfulness techniques will be promoted, a virtual reality device will be used per patient.
Treatment as UsualOther
The group will only receive the pharmacoloical treatment according to the based guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Enhancing cognitive reserve | Active comparator | After the baseline assessment, subjects will be randomly assigned by non-research staff, following the balanced clocks method, to receive a psychological intervention for the improvement of cognitive reserve (N=60) or to the group receiving TAU only (N=60). All assessments will be common to both groups. The experimental group will receive an intervention consisting of 12 weekly sessions of approximately 60 minutes duration. The aim of this intervention is to offer a series of strategies to increase academic and/or work achievements, leisure and free time activities, as well as an improvement in the level of neurocognitive functioning. Most of the tasks to be carried out are based on the use of pencil and paper with audiovisual support. Patients will also receive pharmacological follow-up in each center. A psychologist blind to the results of the assessment will provide the therapeutic approach for the improvement of cognitive reserve. Receives: Behavioral: Enhancing cognitive reserve |
| Placebo group | Placebo comparator | This group will receive only pharmacological treatment supervised by the Psychiatrists of each Unit. Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive reserve
Assess cognitive reserve, a potential mechanism to cope with brain damage. Assessed by the Cognitive Reseve Assessment Scale (CRASH), (Amoretti et al, 2019). The CRASH scale provides a global score and a score for each of the domains that form it (education, occupation, and intellectual and leisure activities). The scale's maximum total score is 90, and it can be calculated using a formula, created with the intention that all domains have the same weighting in the final score. The score for each domain is obtained by adding the scores of the items it contains. For all scores, the higher the result, the better the level of cognitive reserve. .
Measured: one year
Secondary outcomes (3)
Depressive symptoms
Assess the clinical state (depressive symptoms) of the patients pre and post intervention.
The depressive symptoms will be assessed by the Hamilton Depression Rating Scale (HDRS). For the 17-item version, a score of 0-7 is considered to be normal while a score of 20 or higher (indicating at least moderate severity). The total score ranges from 0 to 52. Each question has between three and five possible answers, with a score of 0-2 or 0-4 respectively.
The manic symptoms will be assessed by the Young Mania Rating Scale (YMRS) (Young, 1978) which is a gold-standard clinician-rated assessment tool for severity of manic symptoms. The total YMRS scores ranges from 0 to 60, with higher scores indicating more severe mania.
Measured: one year
Manic symptoms
Assess the severity of manic symptoms of the patients pre and post intervention.
The manic symptoms will be assessed by the Young Mania Rating Scale (YMRS) (Young, 1978) which is a gold-standard clinician-rated assessment tool for severity of manic symptoms. The total YMRS scores ranges from 0 to 60, with higher scores indicating more severe mania.
Measured: one year
Number of participants with subjective cognitive complaints
Related cognitive concerns expressed by people with or without objective evidence of cognitive impairment. It will be assessed by the Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA) The COBRA utilizes queries informed by everyday mental tasks. Sixteen items, including verbal learning and memory, executive functionality, attention/concentration, working memory, processing speed, and mental tracking, are used to measure subjective cognitive dysfunction,14 and a four-point scale is used to rate these items (0 = never, 1 = sometimes, '2 = often, and 3 = always). The total COBRA score is calculated by adding the rating of each item; the highest possible score is 48, and scores of ≥15 indicate moderate to severe subjective cognitive impairment
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start1 Jan 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2023
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.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Experimental, multicentre, randomised, test-retest and control group clinical study to evaluate the efficacy of a cognitive reserve enhancement programme in patients with a diagnosis of bipolar disorder or schizoaffective disorder whose first episode has occurred within the last five years. Patients will be randomised into two groups: one group of patients will receive a psychological intervention for cognitive enhancement and another group of patients will receive only the usual pharmacological treatment (TAU).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- FIDMAG Germanes Hospitalàries
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081634
- Sponsor's protocol ID
- PI18/00810
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy of a Psychological Approach for the Enhancement of Cognitive Reserve in a Bipolar Population With a Recent First Episode
- ClinicalTrials.gov ID
- NCT06081634
- Acronym / sponsor ID
- PI18/00810
- Conditions
- Bipolar Disorder
- Keywords
- Cognitive reserve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- FIDMAG Germanes Hospitalàries
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 13 Oct 2023 (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.
This study aims to adapt and apply a psychological program aimed at improving cognitive reserve (CR) in bipolar patients who have recently presented a first episode of the illness. The purpose of this project is to test both the effectiveness of the psychological intervention as well as the stability of the obtained results after nine months of follow-up. One-hundred and twenty patients (60 patients each centre) will be recruited and assessed with clinical, functioning, quality of life, neuropsychological and RC assessment tools. Then, participants will be randomly assigned to two different conditions: the experimental one, consisting in the implementation of the psychological intervention aiming at improving CR (n=60), and the control one, in which the usual pharmacological treatment will be carried on (n=60). Once the psychological intervention has finished (3 months) re-assessment of all the explored variables at baseline will be performed. Finally, after 12 months from the baseline visit, a re-assessment of all the participants in the study will be carried out to verify that post-intervention obtained results remain stable throughout the complete follow-up period. The investigators hypothesized that patients with a recent first episode who have undergone the intervention program will improve their CR as well as measures related to the severity of the difficulties observed at baseline concerning clinical, functioning, quality of life and neurocognitive performance. A second hypotheses is that all these changes will remain stable after nine month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental, multicentre, randomised, test-retest and control group clinical study to evaluate the efficacy of a cognitive reserve enhancement programme in patients with a diagnosis of bipolar disorder or schizoaffective disorder whose first episode has occurred within the last five years. Patients will be randomised into two groups: one group of patients will receive a psychological intervention for cognitive enhancement and another group of patients will receive only the usual pharmacological treatment (TAU).
| Arm | Type | Receives |
|---|---|---|
| Enhancing cognitive reserve | Active comparator | Behavioral: Enhancing cognitive reserveAfter the baseline assessment, subjects will be randomly assigned by non-research staff, following the balanced clocks method, to receive a psychological intervention for the improvement of cognitive reserve (N=60) or to the group receiving TAU only (N=60). All assessments will be common to both groups. The experimental group will receive an intervention consisting of 12 weekly sessions of approximately 60 minutes duration. The aim of this intervention is to offer a series of strategies to increase academic and/or work achievements, leisure and free time activities, as well as an improvement in the level of neurocognitive functioning. Most of the tasks to be carried out are based on the use of pencil and paper with audiovisual support. Patients will also receive pharmacological follow-up in each center. A psychologist blind to the results of the assessment will provide the therapeutic approach for the improvement of cognitive reserve. |
| Placebo group | Placebo comparator | Other: Treatment as UsualThis group will receive only pharmacological treatment supervised by the Psychiatrists of each Unit. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients between 18 and 40 years of age whose disease onset (first episode) is within the last 5 years.
- Fulfill diagnostic criteria for bipolar disorder (type I or type II) or schizoaffective disorder, bipolar type, according to the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association (DSM-5) based on a semi-structured clinical interview.
- Patients in clinical remission or partial remission at the time of assessment, defined as scores ≤ 10 on the Young Mania Rating Scale (YMRS) (Young, 1978) and ≤ 14 points on the Hamilton Depression Rating Scale (HAMD) (Hamilton, 1960).
- Signed informed consent to participate in the study.
Key exclusion criteria (4 listed)
- Estimated IQ less than 85.
- Any medical condition that may affect neuropsychological performance (such as neurological diseases).
- Presence of any comorbid psychiatric condition (except substance use/abuse).
- Patients who have received any type of psychological intervention in the 6 months prior to the study.
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 |
|---|---|---|
| Enhancing cognitive reserveIntervention in group format (6-8 patients) consisting of 12 weekly sessions, each lasting approximately 60 minutes. The aim of this intervention is to offer a series of strategies to increase academic and/or work achievements, leisure and free time activities, as well as an improvement in the level of neurocognitive functioning. Most of the tasks to be carried out are based on the use of pencil and paper with audiovisual support. Technological resources such as the use of the Internet and some telephone applications will also be used in some sessions. For those sessions in which the practice of mindfulness techniques will be promoted, a virtual reality device will be used per patient. | Behavioural | Enhancing cognitive reserve |
| Treatment as UsualThe group will only receive the pharmacoloical treatment according to the based guidelines. | Other | Placebo group |
Primary outcome
Cognitive reserve
Time frame: one year
Assess cognitive reserve, a potential mechanism to cope with brain damage. Assessed by the Cognitive Reseve Assessment Scale (CRASH), (Amoretti et al, 2019). The CRASH scale provides a global score and a score for each of the domains that form it (education, occupation, and intellectual and leisure activities). The scale's maximum total score is 90, and it can be calculated using a formula, created with the intention that all domains have the same weighting in the final score. The score for each domain is obtained by adding the scores of the items it contains. For all scores, the higher the result, the better the level of cognitive reserve. .
3 secondary outcomes
Depressive symptoms
Time frame: one year
Manic symptoms
Time frame: one year
Number of participants with subjective cognitive complaints
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhancing cognitive reserve and Treatment as Usual in people with Bipolar Disorder, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 13 Oct 2023. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive reserve (time frame: one year). 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 13 Oct 2023.