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

Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Study ID
NCT07039903
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).

Study Details

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.

Key Dates

First listed
Jun 26, 2025
Start date
Sep 1, 2025
Status verified
Jun 2025
Primary completion
Jul 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VECTOR program
    The VECTOR enhancement protocol consists of 12 weekly sessions (90 minutes each of them) in a group format (8-10 individuals) with audiovisual support.
  • No Intervention: Treatment as usual (TAU)
    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.

Primary Outcome Measure

Functioning Assessment Short Test (FAST) [ Time Frame: Baseline, post-treatment (12 weeks) and 12 months ]

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