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

Not Applicable

Not yet recruiting

• Conditions: ADHD; BD

• Registration Number: NCT07039903
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-06-18
• Last Update Submitted: 2025-06-18
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26
• Study Start: 2025-09-01
• Primary Completion: 2026-07-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 68

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functioning Assessment Short Test (FAST)	Baseline, post-treatment (12 weeks) and 12 months	24-item scale assessing disability in six functional domains: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships, and leisure time. Assessed by a blind expert rater.
Clinical Global Impression - Severity (CGI-S)	Baseline, post-treatment (12 weeks) and 12 months	Severity scale measuring global symptom severity. Assessed by a blind expert rater.

Secondary Outcome Measures

Name	Time	Method
Change in the ADHD-Rating Scale (ADHD-RS)	Baseline, post-treatment (12 weeks) and 12 months	The ADHD-RS is an 18-items scale self-report version for assessing symptoms for ADHD DSM-IV. It consists of a subscale of inattention (IN, 9-items), another of hyperactivity/impulsivity (H / I, 9-items) and the total (TOT, 18-items). The interviewees are asked about the frequency of the symptoms over the past 6 months.
Change in the severity of ADHD symptoms	Baseline, post-treatment (12 weeks) and 12 months	Assessed by Connors' Adult ADHD Rating Scales Observer form (CAARS-O-L), an observer-rated questionnaire assessing ADHD symptom severity based on third-party observation, covering the same symptom domains as the self-report version.
Change in the Hamilton Depression	Baseline, post-treatment (12 weeks) and 12 months	Each item is rated on either a 3-point or 5-point Likert-type scale, depending on the symptom being assessed, with higher scores indicating greater severity of depression. The total score for the HDRS-17 ranges from 0 to 52. Common domains evaluated include mood, guilt, suicide ideation, insomnia, anxiety, psychomotor changes, and somatic symptoms.
Change in the Young Mania Rating Scale (YMRS)	Baseline, post-treatment (12 weeks) and 12 months	11-item clinician-rated scale used to assess manic symptoms such as elevated mood, increased motor activity, sleep disturbance, irritability, and thought disorder. Higher scores reflect more severe manic symptoms. Assessed by a blind expert rater.
Change in attention - Trail Making Test Part A (TMT-A)	Baseline, post-treatment (12 weeks) and 12 months	TMT-A assesses processing speed and visual attention. Participants are asked to connect numbered circles in sequence as quickly as possible. Completion time is the outcome measure; shorter times indicate better performance.
Change in cognitive flexibility - Trail Making Test Part B (TMT-B)	Baseline, post-treatment (12 weeks) and 12 months	TMT-B assesses cognitive flexibility, task-switching, and executive control. Participants alternate between numbers and letters in sequence (e.g., 1-A-2-B...). Completion time is recorded, with shorter times indicating better performance.
Change in sustained attention - Conners' Continuous Performance Test (CPT)	Baseline, post-treatment (12 weeks) and 12 months	The CPT is a computerized test that measures sustained attention and impulsivity by recording responses to a series of visual stimuli. Key outcomes include omission errors, commission errors, and reaction time variability.
Change in executive function - Wisconsin Card Sorting Test (WCST)	Baseline, post-treatment (12 weeks) and 12 months	The WCST measures cognitive flexibility and executive functioning. Participants must match cards according to varying rules. Key outcomes include number of categories completed and perseverative errors.
Change in inhibitory control - Stroop Test	Baseline, post-treatment (12 weeks) and 12 months	The Stroop Color-Word Test evaluates selective attention and inhibitory control by measuring the ability to name the color of the ink rather than reading the printed word. Interference score is commonly used.
Change in verbal fluency - Phonemic and Semantic Fluency (PMR)	Baseline, post-treatment (12 weeks) and 12 months	The Verbal Fluency Test assesses executive control and language by requiring the participant to generate as many words as possible starting with a letter (phonemic) or within a category (semantic) in a limited time.

Trial Locations

Locations (1)

Hospital Clínic de Barcelona and Vall d'Hebron University Hospital; 🇪🇸 Barcelona, Spain