Affective Cognitive Training in Mood Disorders and High-risk Relatives (BACE)
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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).
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Astrid Endrup Iversen, PhD student
- Telefonní číslo: +4520461323
- E-mail: astrid.endrup.iversen@regionh.dk
Studijní záloha kontaktů
- Jméno: Hanne Lie Kjærstad, PhD, senior researcher
- E-mail: hanne.lie.kjaerstad@regionh.dk
Studijní místa
-
-
Capital Region of Denmark
-
Frederiksberg, Capital Region of Denmark, Dánsko, 2000
- Nábor
- Neurocognition and Emotion Across Disorders Brain Centre (NEAD)
-
Kontakt:
- Kamilla Woznica Miskowiak, DMSc, DPhil
- Telefonní číslo: +4522771617
- E-mail: kamilla.woznica.miskowiak@regionh.dk
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Žádný zásah: Léčba jako obvykle
|
|
|
Experimentální: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Affective cognitive composite measure
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Dorsal prefrontal cortex activity during emotion regulation
Časové okno: 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)
Časové okno: 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)
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
VERA
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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"
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: Baseline and week 7 (treatment completion)
|
Questionnaire on habitual emotion regulation strategies. |
Baseline and week 7 (treatment completion)
|
|
Attentional Control Scale
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Baseline and week 7 (treatment completion)
|
Hair cortisol as index of long-term systemic cortisol levels |
Baseline and week 7 (treatment completion)
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- H-25024438
- p-2025-18973 (Jiný identifikátor: Danish Data Protection Agency)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .