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

NCT07039903 | Not Yet Recruiting

• 2 other identifiers: PR(AG)041-2025PI24/00671 and PI24/00407
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD; BD

Keywords

clinical trial; Cognitive Behavioral Therapy; Psychological treatment; Bipolar Disorder; Bipolar and Related Disorders; BD; Attention-Deficit Hyperactivity Disorder; ADHD; Functional remediation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, post-treatment (12 weeks) and 12 months

Secondary Outcomes (11)

• Change in the ADHD-Rating Scale (ADHD-RS)

  Baseline, post-treatment (12 weeks) and 12 months

• Change in the severity of ADHD symptoms

  Baseline, post-treatment (12 weeks) and 12 months

• Change in the severity of ADHD symptoms

  Baseline, post-treatment (12 weeks) and 12 months

• Change in the Hamilton Depression

  Baseline, post-treatment (12 weeks) and 12 months

• Change in the Young Mania Rating Scale (YMRS)

  Baseline, post-treatment (12 weeks) and 12 months

Other Outcomes (2)

• CSQ-8

  12 weeks (post)

• Working Alliance Inventory

  12 weeks (post)

Study Arms (2)

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.

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.

Interventions

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).

VECTOR program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ADHD rating scale≥24

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• Hospital Clinic of Barcelona: collaborator

Study Sites (1)

Hospital Clínic de Barcelona and Vall d'Hebron University Hospital

Barcelona, Barcelona, 08035, Spain

Location

Related Publications (3)

• 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.

  PMID: 23511717 BACKGROUND

• Corrales 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.

  PMID: 38103281 BACKGROUND

• Amoretti 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.

  PMID: 40015388 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Bipolar Disorder; Bipolar and Related Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)