Clinical trial NCT06081634: Study Efficacy of Enhancing Cognitive Reserve in Patients With a First Bipolar Episode
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Keywords: Cognitive reserve
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: FIDMAG Germanes Hospitalàries
First posted: 2023-10-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Cognitive reserve
timeFrame: one year
Secondary outcomes:
measure: Depressive symptoms
timeFrame: one year
measure: Manic symptoms
timeFrame: one year
measure: Number of participants with subjective cognitive complaints
timeFrame: One year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
References: