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Affective Cognitive Training in Mood Disorders and High-risk Relatives (BACE)

30 ottobre 2026 aggiornato da: Hanne Lie Kjærstad, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Brain Marker for Affective Cognitive Enhancement Following Targeted Training in Patients With Mood Disorders and High-risk Relatives: A Randomized Controlled Trial (BACE)

The aim of this clinical trial is to investigate the effects of a six-week targeted affective cognitive training, combining virtual reality and computer-based exercises, in symptomatically stable patients with mood disorders (major depressive disorder or bipolar disorder) and unaffected first-degree relatives.

The investigators hypothesize that targeted affective cognitive training, compared with treatment as usual, will improve affective cognition (primary outcome), assessed using a composite measure of emotion regulation and facial emotion recognition.

Secondly, the investigators hypothesize that the training will improve self-reported emotion regulation abilities and associated neural activity during emotion regulation, including changes in dorsolateral prefrontal cortex activity.

Finally, the investigators will explore whether the training affects broader cognitive functioning, psychosocial functioning, quality of life, and longer-term clinical outcomes, including relapse or onset of mood disorder.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The study will include adults aged 18-60 years with major depressive disorder or bipolar disorder who are in full or partial remission at inclusion, as well as unaffected first-degree relatives of individuals with mood disorders, with the sample enriched for individuals experiencing emotion regulation difficulties. Symptomatic stability is defined as a score of ≤14 on both the 17-item Hamilton Depression Rating Scale (HDRS-17) and the Young Mania Rating Scale (YMRS). To accommodate an approximated drop-out rate of 20% from baseline to treatment completion, the investigators will recruit up to 100 participants until full data sets are obtained for 80 participants (40 participants per arm).

Participants will be recruited through the outpatient Copenhagen Affective Disorder Clinic, other mental health centers in the Capital Region of Denmark, through consultant psychiatrists in the Capital Region and through advertisements on relevant websites. Potentially eligible participants will receive oral and written information about the study and provide written informed consent before undergoing screening and baseline assessments.

At baseline, participants will complete a comprehensive assessment of affective and non-affective cognition. Affective cognition will be assessed using measures of emotion processing and regulation, while non-affective cognition will be assessed across domains including working memory, executive functioning, attention, processing speed and verbal learning and memory. Participants will also complete questionnaires assessing emotion regulation difficulties, habitual emotion-regulation strategies, quality of life and other relevant clinical characteristics. Psychosocial functioning will be assessed using the Functioning Assessment Short Test. Clinical assessments will include the HDRS-17 and YMRS.

Participants will additionally undergo magnetic resonance imaging, including structural imaging, resting-state functional MRI and task-based functional MRI. The task-based paradigms assess emotion reactivity and regulation, processing of emotional faces, and working memory. Biological samples, including blood and hair samples, will be collected to explore potential biological correlates and predictors of treatment response.

Following baseline assessment, participants will be randomized in a 1:1 ratio to either a six-week targeted affective cognitive training program or treatment as usual. The cognitive training consists of 10 individually delivered sessions combining virtual reality scenarios and computer-based exercises. The training targets attention, executive functioning, emotion recognition, and cognitive reappraisal.

The primary outcome is change in an affective cognition composite comprising performance-based measures of emotion regulation and facial expression recognition. Secondary outcomes include changes in self-reported emotion regulation difficulties and dorsolateral prefrontal cortex activity during emotion regulation. Exploratory outcomes include changes in broader cognitive functioning, psychosocial functioning, quality of life and other neural and biological measures.

Cognitive assessments, clinical ratings, questionnaires, biological sampling and MRI assessments will be repeated 1 week after the intervention period. Longer-term follow-up assessments will be conducted at 6 and 24 months to explore psychosocial functioning and clinical outcomes, including relapse among participants with mood disorders and onset of psychiatric disorder among unaffected relatives.

Block randomization will be conducted using the automated randomization module in Research Electronic Data Capture (REDCap) based on an uploaded blocked randomization list stratified by age (< or ≥ 35 years) and diagnosis (major depressive disorder, bipolar disorder or no diagnosis).

Tipo di studio

Interventistico

Iscrizione (Stimato)

100

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Danimarca
    • Capital Region of Denmark
      • Frederiksberg, Capital Region of Denmark, Danimarca, 2000
        • Reclutamento
        • Neurocognition and Emotion Across Disorders Brain Centre (NEAD)
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 60 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Confirmed ICD-10 diagnosis of BD or previous UD in partial, or full remission (Hamilton Depression Rating Scale-17 items and Young Mania Rating Scale scores ≤14)
  • Self-reported difficulties with emotion regulation (measured with Difficulties in Emotion Regulation Scale DERS: total score or at least two subscores ≥ 1 SD above expected norms)
  • Fluency in Danish language

Exclusion Criteria:

  • Diagnosis of schizophrenia
  • Autism spectrum disorder
  • Neurological disorder
  • Alcohol or substance abuse
  • Previous severe head trauma
  • Pregnancy
  • Claustrophobia
  • Pacemaker or other metal implants
  • Daily use of benzodiazepines > 22.5 mg. oxazepam or > 7.5 mg. diazepam per day
  • Received electroconvulsive therapy < 3 months prior to participation

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Trattamento come al solito
Sperimentale: Targeted affective cognitive training
Comportamentale: Targeted affective cognitive training

A six-week targeted affective cognitive training program comprising 10 individual sessions. The training includes psychoeducation, virtual reality tasks, computer-based exercises and between-session assignments.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Affective cognitive composite measure
Lasso di tempo: Baseline and week 7 (treatment completion)

A composite score of affective cognition based on the following tests: the Social Scenarios Task (down-regulation of negative emotion), the VERA task (down-regulation of negative emotion) and the Facial Expression Recognition Task (discrimination accuracy and speed of facial expression recognition). Higher scores reflect better performance.
Baseline and week 7 (treatment completion)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Dorsal prefrontal cortex activity during emotion regulation
Lasso di tempo: Baseline and week 7 (treatment completion)

Functional magnetic resonance imaging (fMRI) measure of brain activity in a dorsal prefrontal volume of interest during an emotion regulation task using IAPS pictures (down-regulation versus react to negative pictures).
Baseline and week 7 (treatment completion)
Difficulties in Emotion Regulation Scale (DERS)
Lasso di tempo: Baseline, week 7 (treatment completion), 6 months (follow-up)

Questionnaire assessing self-rated emotion regulation difficulties. Lower scores reflect better outcome.
Baseline, week 7 (treatment completion), 6 months (follow-up)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
VERA
Lasso di tempo: Baseline and week 7

Virtual Reality task assessing emotion regulation. Score range 1-5 (lower scores reflect better outcome).
Baseline and week 7
Social Scenarios Task
Lasso di tempo: Baseline and week 7 (treatment completion)

Computerized neuropsychological test assessing emotional reactivity and emotion regulation in positive and negative situations. Outcomes include emotion reactivity (score range 0-100, lower scores reflect better outcome) and dampening (score range 0-100, lower scores reflect better outcome).
Baseline and week 7 (treatment completion)
Facial Expression Recognition Task (FERT)
Lasso di tempo: Baseline and week 7 (treatment completion)

Computerized neuropsychological test assessing emotion recognition. Outcomes include reaction time (no score range, lower scores reflect better performance) and hit rate (score range 0-1, higher scores reflect better performance).
Baseline and week 7 (treatment completion)
Valence bias task
Lasso di tempo: Baseline and week 7 (treatment completion)

Computerized task assessing valence judgements of emotionally ambiguous and clearly valenced stimuli, including faces and scenes
Baseline and week 7 (treatment completion)
Hamilton Depression Rating Scale (HDRS-17)
Lasso di tempo: Baseline and week 7 (treatment completion)

Rating inventory assessing depressive symptoms. Score range 0-52. Lower scores reflect better outcome.
Baseline and week 7 (treatment completion)
Young Mania Rating Scale (YMRS)
Lasso di tempo: Baseline and week 7 (treatment completion)

Rating inventory assessing (hypo)manic symptoms. Score range 0-60. Lower scores reflect better outcome.
Baseline and week 7 (treatment completion)
Functional Assessment Short Test (FAST)
Lasso di tempo: Baseline and week 7 (treatment completion)

Interview-based assessment of functional capacity. Score range 0-72. Lower scores reflect better outcome.
Baseline and week 7 (treatment completion)
Neural activity during an implicit emotional face-processing task
Lasso di tempo: Baseline and week 7 (treatment completion)

Functional magnetic resonance imaging (fMRI) measure of brain activity during fearful and happy face processing
Baseline and week 7 (treatment completion)
Neural activity during a verbal n-back task
Lasso di tempo: Baseline and week 7 (treatment completion)

Functional magnetic resonance imaging (fMRI) measure of brain activity during a working memory task
Baseline and week 7 (treatment completion)
Neural activity during resting state
Lasso di tempo: Baseline and week 7 (treatment completion)

Functional magnetic resonance imaging (fMRI) measure of brain activity during resting state
Baseline and week 7 (treatment completion)
Changes in brain structure
Lasso di tempo: Baseline and week 7 (treatment completion)

Structural magnetic resonance imaging (sMRI) measure of brain morphology, including regional brain volumes and cortical thickness
Baseline and week 7 (treatment completion)
Wechsler Adult Intelligence Scale (WAIS)-III Letter-Number Sequencing
Lasso di tempo: Baseline and week 7 (treatment completion)

Neuropsychological test assessing working memory. Score range 0-21. Higher scores reflect better performance.
Baseline and week 7 (treatment completion)
Trail Making Test A
Lasso di tempo: Baseline and week 7 (treatment completion)

Neuropsychological test assessing attention and processing speed. Scored as time to complete. Lower scores reflect better performance.
Baseline and week 7 (treatment completion)
Trail Making Test B
Lasso di tempo: Baseline and week 7 (treatment completion)

Neuropsychological test assessing executive function. Scored as time to complete. Lower scores reflect better performance.
Baseline and week 7 (treatment completion)
Verbal fluency with letters "S" and "D"
Lasso di tempo: Baseline and week 7 (treatment completion)

Neuropsychological test assessing executive functions. No score range. Higher scores reflect better performance.
Baseline and week 7 (treatment completion)
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Digit Span Test
Lasso di tempo: Baseline and week 7 (treatment completion)

Neuropsychological test assessing attention. Score range 0-16. Higher scores reflect better performance.
Baseline and week 7 (treatment completion)
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Coding
Lasso di tempo: Baseline and week 7 (treatment completion)

Neuropsychological test assessing psychomotor speed. Score range 0-89. Higher scores reflect better performance.
Baseline and week 7 (treatment completion)
Rey Auditory Verbal Learning Test
Lasso di tempo: Baseline and week 7 (treatment completion)

Neuropsychological test assessing verbal memory. Outcomes include total recall (score range 0-75), immediate recall (score range 0-15), and delayed recall (score range 0-15). Higher scores reflect better performance.
Baseline and week 7 (treatment completion)
Emotion Regulation Questionnaire-30 (ERQ-30)
Lasso di tempo: Baseline and week 7 (treatment completion)

Questionnaire on habitual emotion regulation strategies.
Baseline and week 7 (treatment completion)
Attentional Control Scale
Lasso di tempo: Baseline and week 7 (treatment completion)

Questionnaire on perceived attentional control. Score range 20-80. Higher scores indicate better attentional control.
Baseline and week 7 (treatment completion)
Work and Social Adjustment Scale (WSAS)
Lasso di tempo: Baseline, week 7 (treatment completion), 6 months (follow-up)

Questionnaire assessing occupational functioning. Score range 0-40. Higher scores reflect worse outcome.
Baseline, week 7 (treatment completion), 6 months (follow-up)
Sheehan's Disability Scale (SDS)
Lasso di tempo: Baseline, week 7 (treatment completion), 6 months (follow-up)

Questionnaire assessing everyday functioning. Score range 0-30. Higher scores reflect worse outcome.
Baseline, week 7 (treatment completion), 6 months (follow-up)
Cognitive Complaints in Bipolar Disorder Rating Scale (COBRA)
Lasso di tempo: Baseline and week 7 (treatment completion)

Questionnaire on subjective cognitive complaints. Score range 0-48. Higher scores means worse outcome
Baseline and week 7 (treatment completion)
State-Trait Anxiety Inventory Questionnaire (STAI)
Lasso di tempo: Baseline and week 7 (treatment completion)

Questionnaire on state and trait anxiety. Each subscale ranges from 20-80. Higher scores indicate greater anxiety.
Baseline and week 7 (treatment completion)
Metacognitions Questionnaire (MCQ-30)
Lasso di tempo: Baseline and week 7 (treatment completion)

Questionnaire on metacognitive beliefs. Score range 30-120. Higher scores indicate more maladaptive metacognitive beliefs.
Baseline and week 7 (treatment completion)
European Quality of Life - 5 Dimensions (EQ-5D)
Lasso di tempo: Baseline and week 7 (treatment completion)

Questionnaire on health-related quality of life across five dimensions. Higher index scores indicate better health-related quality of life.
Baseline and week 7 (treatment completion)
Metacognitive Knowledge and Experience
Lasso di tempo: Baseline and week 7 (treatment completion)

Ratings of perceived general cognitive functioning and memory performance. Score range -3 to +3, with higher scores indicating better perceived cognitive functioning.
Baseline and week 7 (treatment completion)
Blood sample
Lasso di tempo: Baseline and week 7 (treatment completion)

Blood-based markers of inflammation and immune activity (C-reactive protein (CRP) and leukocytes)
Baseline and week 7 (treatment completion)
Hair cortisol
Lasso di tempo: Baseline and week 7 (treatment completion)

Hair cortisol as index of long-term systemic cortisol levels
Baseline and week 7 (treatment completion)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

17 novembre 2025

Completamento primario (Stimato)

31 ottobre 2027

Completamento dello studio (Stimato)

1 ottobre 2029

Date di iscrizione allo studio

Primo inviato

30 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 ottobre 2026

Primo Inserito (Effettivo)

5 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • H-25024438
  • p-2025-18973 (Altro identificatore: Danish Data Protection Agency)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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