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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
68
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).
Hospital Clínic de Barcelona and Vall d'Hebron University Hospital
Barcelona, Barcelona, Spain
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.
Time frame: 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.
Time frame: Baseline, post-treatment (12 weeks) and 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, post-treatment (12 weeks) and 12 months
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