A Novel Psychological Intervention for Adults With Bipolar Disorder and Attention Deficit Hyperactivity Disorder Comorbidity (VECTOR)
NCT07039903, Not applicable, Not yet recruiting, Hospital Universitari Vall d'Hebron Research Institute
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Novel Psychological Intervention for Adults With Bipolar Disorder and Attention Deficit Hyperactivity Disorder Comorbidity (VECTOR) | ClinicalTrials.gov |
| NCT number | NCT07039903 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 68 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Hospital Universitari Vall d'Hebron Research Institute | ClinicalTrials.gov |
| Conditions | ADHD, BD | ClinicalTrials.gov |
| Interventions | Cognitive behavioral therapy (CBT) + Functional Remediation (FR) | ClinicalTrials.gov |
| First posted | 2025-06-26 | ClinicalTrials.gov |
| Last updated | 2025-06-26 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Functioning Assessment Short Test (FAST) | Baseline, post-treatment (12 weeks) and 12 months | 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. | ClinicalTrials.gov |
| Primary | Clinical Global Impression - Severity (CGI-S) | Baseline, post-treatment (12 weeks) and 12 months | Severity scale measuring global symptom severity. Assessed by a blind expert rater. | ClinicalTrials.gov |
| Secondary | Change in the ADHD-Rating Scale (ADHD-RS) | Baseline, post-treatment (12 weeks) and 12 months | 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. | ClinicalTrials.gov |
| Secondary | Change in the severity of ADHD symptoms | Baseline, post-treatment (12 weeks) and 12 months | 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. | ClinicalTrials.gov |
| Secondary | Change in the severity of ADHD symptoms | Baseline, post-treatment (12 weeks) and 12 months | 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. | ClinicalTrials.gov |
| Secondary | Change in the Hamilton Depression | Baseline, post-treatment (12 weeks) and 12 months | 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. | ClinicalTrials.gov |
| Secondary | Change in the Young Mania Rating Scale (YMRS) | Baseline, post-treatment (12 weeks) and 12 months | 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. | ClinicalTrials.gov |
| Secondary | Change in attention - Trail Making Test Part A (TMT-A) | Baseline, post-treatment (12 weeks) and 12 months | 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. | ClinicalTrials.gov |
| Secondary | Change in cognitive flexibility - Trail Making Test Part B (TMT-B) | Baseline, post-treatment (12 weeks) and 12 months | 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. | ClinicalTrials.gov |
| Secondary | Change in sustained attention - Conners' Continuous Performance Test (CPT) | Baseline, post-treatment (12 weeks) and 12 months | 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. | ClinicalTrials.gov |
| Secondary | Change in executive function - Wisconsin Card Sorting Test (WCST) | Baseline, post-treatment (12 weeks) and 12 months | 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. | ClinicalTrials.gov |
| Secondary | Change in inhibitory control - Stroop Test | Baseline, post-treatment (12 weeks) and 12 months | 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. | ClinicalTrials.gov |
| Secondary | Change in verbal fluency - Phonemic and Semantic Fluency (PMR) | Baseline, post-treatment (12 weeks) and 12 months | 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. | ClinicalTrials.gov |
| Other | CSQ-8 | 12 weeks (post) | Client Satisfaction Questionnaire-8 (self-report) - in order to evaluate the treatment satisfaction | ClinicalTrials.gov |
| Other | Working Alliance Inventory | 12 weeks (post) | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 3
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 8
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Card Sorting Test (Berg) | Secondary outcome | ConductCognition |
| Category Fluency | Secondary outcome | ConductCognition |
| Continuous Performance Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Task Switching Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)