Study Efficacy of Enhancing Cognitive Reserve in Patients With a First Bipolar Episode

NCT06081634 | Completed

• 1 other identifier: PI18/00810
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

Cognitive reserve

Outcome Measures

Primary Outcomes (1)

• 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. .

  one year

Secondary Outcomes (3)

• Depressive symptoms

  one year

• Manic symptoms

  one year

• Number of participants with subjective cognitive complaints

  One year

Study Arms (2)

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.

Behavioral: Enhancing cognitive reserve

Placebo group

PLACEBO COMPARATOR

This group will receive only pharmacological treatment supervised by the Psychiatrists of each Unit.

Other: Treatment as Usual

Interventions

Enhancing cognitive reserve BEHAVIORAL

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.

Enhancing cognitive reserve

Treatment as Usual OTHER

The group will only receive the pharmacoloical treatment according to the based guidelines.

Placebo group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• FIDMAG Germanes Hospitalàries: collaborator

Study Sites (1)

Hospital Clinic

Barcelona, Spain

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 13, 2023
• Study Start: January 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2023
• Last Updated: October 13, 2023

Record last verified: 2023-09

Locations

ES (1)