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| ID | Type | Description | Link |
|---|---|---|---|
| PI24/00671 and PI24/00407 | Other Grant/Funding Number | Instituto de Salud Carlos III |
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| Name | Class |
|---|---|
| Hospital Clinic of Barcelona | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, post-treatment (12 weeks) and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| CSQ-8 | Client Satisfaction Questionnaire-8 (self-report) - in order to evaluate the treatment satisfaction | 12 weeks (post) |
| Working Alliance Inventory | The Working Alliance Inventory (WAI) is a self-report questionnaire designed to assess the quality of the therapeutic relationship. It evaluates three key components: agreement on therapeutic goals, agreement on tasks, and the emotional bond between therapist and patient. Higher scores indicate a stronger working alliance. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnic de Barcelona and Vall d'Hebron University Hospital | Barcelona | Barcelona | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23511717 | Result | 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. | |
| 38103281 |
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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.
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|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, post-treatment (12 weeks) and 12 months |
| 12 weeks (post) |
| Result |
| 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. |
| 40015388 | Result | 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. |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D001714 | Bipolar Disorder |
| D000068105 | Bipolar and Related Disorders |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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