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

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)

Overview

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.

Interventions

• Behavioral Cognitive behavioral therapy (CBT) + Functional Remediation (FR)
  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 outcome measures

• Functioning Assessment Short Test (FAST) [Time frame: Baseline, post-treatment (12 weeks) and 12 months]
• Clinical Global Impression - Severity (CGI-S) [Time frame: Baseline, post-treatment (12 weeks) and 12 months]

Secondary outcome measures (11)

• Change in the ADHD-Rating Scale (ADHD-RS) [Time frame: Baseline, post-treatment (12 weeks) and 12 months]
• Change in the severity of ADHD symptoms [Time frame: Baseline, post-treatment (12 weeks) and 12 months]
• Change in the severity of ADHD symptoms [Time frame: Baseline, post-treatment (12 weeks) and 12 months]
• Change in the Hamilton Depression [Time frame: Baseline, post-treatment (12 weeks) and 12 months]
• Change in the Young Mania Rating Scale (YMRS) [Time frame: Baseline, post-treatment (12 weeks) and 12 months]
• Change in attention - Trail Making Test Part A (TMT-A) [Time frame: Baseline, post-treatment (12 weeks) and 12 months]
• Change in cognitive flexibility - Trail Making Test Part B (TMT-B) [Time frame: Baseline, post-treatment (12 weeks) and 12 months]
• Change in sustained attention - Conners' Continuous Performance Test (CPT) [Time frame: Baseline, post-treatment (12 weeks) and 12 months]
• Change in executive function - Wisconsin Card Sorting Test (WCST) [Time frame: Baseline, post-treatment (12 weeks) and 12 months]
• Change in inhibitory control - Stroop Test [Time frame: Baseline, post-treatment (12 weeks) and 12 months]
• Change in verbal fluency - Phonemic and Semantic Fluency (PMR) [Time frame: Baseline, post-treatment (12 weeks) and 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Hospital Clínic de Barcelona and Vall d'Hebron University Hospital — Barcelona

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, Is PMID 23511717
• 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
• 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 revi PMID 40015388

Identifiers

NCT: NCT07039903 · PR(AG)041-2025 · PI24/00671 and PI24/00407

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗