A Novel Psychological Intervention for Adults With Bipolar Disorder and Attention Deficit Hyperac… (NCT07039903) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Novel Psychological Intervention for Adults With Bipolar Disorder and Attention Deficit Hyperactivity Disorder Comorbidity (VECTOR)
Spain68 participantsStarted 2025-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Functioning Assessment Short Test (FAST)
Timeframe: Baseline, post-treatment (12 weeks) and 12 months
2
Clinical Global Impression - Severity (CGI-S)
Timeframe: Baseline, post-treatment (12 weeks) and 12 months
Trial details
NCT IDNCT07039903
SponsorHospital Universitari Vall d'Hebron Research Institute