A Novel Psychological Intervention for Adults With Bipolar Disorder and Attention Deficit Hyperactivity Disorder Comorbidity (VECTOR)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2027-12-31

Brief Summary

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Cognitive dysfunctions are present in Bipolar Disorder (BD) and Attention Deficit Hyperactivity Disorder (ADHD) and may negatively impact psychosocial functioning. Further, comorbid BD and ADHD (BD-ADHD) is prevalent, associated with an earlier BD onset and a less favorable prognosis. Nevertheless, there is a paucity of research dedicated to the characterization and treatment of comorbid BD-ADHD.

This study aims to develop and evaluate the effectiveness of a novel psychological group intervention (VECTOR) for adults with BD-ADHD. VECTOR integrates elements from Cognitive Behavioral Therapy (CBT) for ADHD and Functional Remediation (FR) for BD.

Eighty patients will be randomized (1:1) to receive either the VECTOR program (12 weekly group sessions) or treatment as usual (TAU).

It is expected that the VECTOR program will result in greater improvements in functioning and symptom reduction compared to TAU.

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Detailed Description

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Conditions

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ADHD BD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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VECTOR program

The VECTOR enhancement protocol consists of 12 weekly sessions (90 minutes each of them) in a group format (8-10 individuals) with audiovisual support.

Group Type EXPERIMENTAL

Cognitive behavioral therapy (CBT) + Functional Remediation (FR)

Intervention Type BEHAVIORAL

VECTOR will provide a newly designed intervention, based on the adaptation of two existing evidence-based and effective interventions (CBT for ADHD and FR for BD)(Corrales et al., 2024; Torrent et al., 2013).

Treatment as usual (TAU)

All participants will receive standard care in accordance with the current practice at the participating centre, respecting international recommendations for the management of their illness.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive behavioral therapy (CBT) + Functional Remediation (FR)

VECTOR will provide a newly designed intervention, based on the adaptation of two existing evidence-based and effective interventions (CBT for ADHD and FR for BD)(Corrales et al., 2024; Torrent et al., 2013).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Fulfill DSM-5 criteria for BDI or BDII and ADHD using the Structured Clinical Interview for DSM-5 and the Conners' Adult ADHD Diagnostic Interview (CAARS)
* Aged ≥18
* Stable pharmacological treatment for at least the past three months.
* Being in full or partial remission Young Mania Rating Scale (YMRS) ≤ 10, Hamilton Depression Rating Scale (HDRS) ≤ 14) at the time of the inclusion and assessment
* ADHD rating scale≥24

Exclusion Criteria

* Any comorbid psychiatric condition
* Diagnosis of substance abuse disorder in the past 12 months
* Intellectual disability (intelligence quotient \< 70)
* Having any Central Nervous System illness, independent of primary psychiatric diagnosis, hampering neuropsychological performance
* Participation in a structured psychological intervention during the study period.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No