ADHDVECTORNCT07039903
A Novel Psychological Intervention for Adults With Bipolar Disorder and Attention Deficit Hyperactivity Disorder Comorbidity (VECTOR)
A study testing Cognitive behavioral therapy (CBT) + Functional Remediation (FR) in people with ADHD and BD, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Cognitive behavioral therapy (CBT) + Functional Remediation (FR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2025to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Clínic de Barcelona and Vall d'Hebron University Hospital
Barcelona, Barcelona, 08035
Silvia Amoretti, PhD, +34935578820, Silvia.amoretti@vhir.org
Carla Torrent, PhD, ctorrent@recerca.clinic.cat
About this study
Official 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)
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.
Read more
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.
- Being tested
- Cognitive behavioral therapy (CBT) + Functional Remediation (FR)
- Keywords
- clinical trial, Cognitive Behavioral Therapy, Psychological treatment, Bipolar Disorder, Bipolar and Related Disorders, BD, Attention-Deficit Hyperactivity Disorder, ADHD, Functional remediation
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Bipolar Disorder, Bipolar and Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy (CBT) + Functional Remediation (FR)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| VECTOR program | Experimental | The VECTOR enhancement protocol consists of 12 weekly sessions (90 minutes each of them) in a group format (8-10 individuals) with audiovisual support. Receives: Behavioral: Cognitive behavioral therapy (CBT) + Functional Remediation (FR) |
| Treatment as usual (TAU) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functioning Assessment Short Test (FAST)
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.
Measured: Baseline, post-treatment (12 weeks) and 12 months
Clinical Global Impression - Severity (CGI-S)
Severity scale measuring global symptom severity. Assessed by a blind expert rater.
Measured: Baseline, post-treatment (12 weeks) and 12 months
Secondary outcomes (11)
Change in the ADHD-Rating Scale (ADHD-RS)
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.
Measured: Baseline, post-treatment (12 weeks) and 12 months
Change in the severity of ADHD symptoms
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.
Measured: Baseline, post-treatment (12 weeks) and 12 months
Change in the severity of ADHD symptoms
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.
Measured: Baseline, post-treatment (12 weeks) and 12 months
Change in the Hamilton Depression
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.
Measured: Baseline, post-treatment (12 weeks) and 12 months
Change in the Young Mania Rating Scale (YMRS)
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.
Measured: Baseline, post-treatment (12 weeks) and 12 months
Change in attention - Trail Making Test Part A (TMT-A)
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.
Measured: Baseline, post-treatment (12 weeks) and 12 months
Change in cognitive flexibility - Trail Making Test Part B (TMT-B)
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.
Measured: Baseline, post-treatment (12 weeks) and 12 months
Change in sustained attention - Conners' Continuous Performance Test (CPT)
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.
Measured: Baseline, post-treatment (12 weeks) and 12 months
Change in executive function - Wisconsin Card Sorting Test (WCST)
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.
Measured: Baseline, post-treatment (12 weeks) and 12 months
Change in inhibitory control - Stroop Test
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.
Measured: Baseline, post-treatment (12 weeks) and 12 months
Change in verbal fluency - Phonemic and Semantic Fluency (PMR)
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.
Measured: Baseline, post-treatment (12 weeks) and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039903
- Sponsor's protocol ID
- PR(AG)041-2025
- Other IDs
- PI24/00671 and PI24/00407
- Acronym
- VECTOR
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share individual participant data (IPD) due to ethical and legal constraints related to data privacy and participant confidentiality, in accordance with applicable regulations and institutional policies.
Publications
Torrent C, Bonnin Cdel M, Martinez-Aran A, Valle J, Amann BL, Gonzalez-Pinto A, Crespo JM, Ibanez A, Garcia-Portilla MP, Tabares-Seisdedos R, Arango C, Colom F, Sole B, Pacchiarotti I, Rosa AR, Ayuso-Mateos JL, Anaya C, Fernandez P, Landin-Romero R, Alonso-Lana S, Ortiz-Gil J, Segura B, Barbeito S, Vega P, Fernandez M, Ugarte A, Subira M, Cerrillo E, Custal N, Menchon JM, Saiz-Ruiz J, Rodao JM, Isella S, Alegria A, Al-Halabi S, Bobes J, Galvan G, Saiz PA, Balanza-Martinez V, Selva G, Fuentes-Dura I, Correa P, Mayoral M, Chiclana G, Merchan-Naranjo J, Rapado-Castro M, Salamero M, Vieta E. Efficacy of functional remediation in bipolar disorder: a multicenter randomized controlled study. Am J Psychiatry. 2013 Aug;170(8):852-9. doi: 10.1176/appi.ajp.2012.12070971.
PubMed 23511717Corrales M, Garcia-Gonzalez S, Richarte V, Fadeuilhe C, Daigre C, Garcia-Gea E, Ramos-Quiroga JA. Long-term efficacy of a new 6-session cognitive behavioral therapy for adults with attention-deficit/hyperactivity disorder: A randomized, controlled clinical trial. Psychiatry Res. 2024 Jan;331:115642. doi: 10.1016/j.psychres.2023.115642. Epub 2023 Nov 27.
PubMed 38103281Amoretti S, De Prisco M, Clougher D, Garriga M, Corrales M, Fadeuilhe C, Forte MF, Martinez-Aran A, Oliva V, Parramon-Puig G, Richarte V, Amann BL, Oliva F, Ruiz A, Sole B, Valenti M, Crespin JJ, Arteaga-Henriquez G, Vieta E, Ramos-Quiroga JA, Torrent C. Neurocognitive and psychosocial functioning profiles in bipolar disorder and comorbid attention deficit hyperactivity disorder: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2025 Apr;171:106081. doi: 10.1016/j.neubiorev.2025.106081. Epub 2025 Feb 26.
PubMed 40015388