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

NCT ID: NCT06081634

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2023-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Enhancing cognitive reserve

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.

Group Type: ACTIVE_COMPARATOR

Enhancing cognitive reserve

Intervention Type: 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.

Placebo group

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

Group Type: PLACEBO_COMPARATOR

Treatment as Usual

Intervention Type: OTHER

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

Interventions

Enhancing cognitive reserve

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.

Intervention Type: BEHAVIORAL

Treatment as Usual

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

FIDMAG Germanes Hospitalàries

OTHER

Sponsor Role: collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Clinic

Barcelona, , Spain

Countries

Spain

Other Identifiers

PI18/00810

Identifier Type: -

Identifier Source: org_study_id