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NCT Number: NCT07039903

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínic de Barcelona and Vall d'Hebron University Hospital

Barcelona, 08035, Spain

Location contact

Carla Torrent, PhD

CONTACT

[email protected]

Carla Torrent, PhD

PRINCIPAL_INVESTIGATOR

Silvia Amoretti, PhD

CONTACT

[email protected]

+34935578820

Silvia Amoretti, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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).

Primary outcomes

  1. Functioning Assessment Short Test (FAST)

    Time frame: 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.

  2. Clinical Global Impression - Severity (CGI-S)

    Time frame: Baseline, post-treatment (12 weeks) and 12 months

    Severity scale measuring global symptom severity. Assessed by a blind expert rater.

Secondary outcomes

  1. Change in the ADHD-Rating Scale (ADHD-RS)

    Time frame: 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.

  2. Change in the severity of ADHD symptoms

    Time frame: Baseline, post-treatment (12 weeks) and 12 months

    Assessed by Connors' Adult ADHD Rating Scales Self-report form (CAARS-S:L), a self-report questionnaire evaluating the severity of ADHD symptoms across multiple domains, including inattention and hyperactivity/impulsivity.

  3. Change in the severity of ADHD symptoms

    Time frame: 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.

  4. Change in the Hamilton Depression

    Time frame: 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.

  5. Change in the Young Mania Rating Scale (YMRS)

    Time frame: 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.

  6. Change in attention - Trail Making Test Part A (TMT-A)

    Time frame: 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.

  7. Change in cognitive flexibility - Trail Making Test Part B (TMT-B)

    Time frame: 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.

  8. Change in sustained attention - Conners' Continuous Performance Test (CPT)

    Time frame: 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.

  9. Change in executive function - Wisconsin Card Sorting Test (WCST)

    Time frame: 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.

  10. Change in inhibitory control - Stroop Test

    Time frame: 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.

  11. Change in verbal fluency - Phonemic and Semantic Fluency (PMR)

    Time frame: 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.

Other outcomes

  1. CSQ-8

    Time frame: 12 weeks (post)

    Client Satisfaction Questionnaire-8 (self-report) - in order to evaluate the treatment satisfaction

  2. Working Alliance Inventory

    Time frame: 12 weeks (post)

    The Working Alliance Inventory (WAI) is a self-report questionnaire designed to assess the quality of the therapeutic relationship. It evaluates three key components: agreement on therapeutic goals, agreement on tasks, and the emotional bond between therapist and patient. Higher scores indicate a stronger working alliance.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Collaborators

  • Hospital Clinic of Barcelona

Registry information

Official study title

Bridging the Gap in the Study of Bipolar Disorder and Attention Deficit Hyperactivity Disorder: Impact of cognitiVE Reserve and funCtioning in a Newly Designed Treatment intervenTion for comORbidity (VECTOR)

Acronym: VECTOR

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 26, 2025
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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