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

Vall d'Hebron University Hospital (HUVH)

Status: Not yet enrolling

Conditions: BD; ADHD

Treatments: Behavioral: Cognitive behavioral therapy (CBT) + Functional Remediation (FR)

Study type: Interventional

Funder types: Other

Identifiers

NCT07039903

PR(AG)041-2025

PI24/00671 and PI24/00407 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

VECTOR program

Experimental group

Description:

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

Treatment:

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

Treatment as usual (TAU)

No Intervention group

Description:

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.