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Recruiting NCT07920302

Affective Cognitive Training in Mood Disorders and High-risk Relatives

Conditions: Major Depressive Disorder (MDD), Bipolar Disorder (BD)

Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Location: Neurocognition and Emotion Across Disorders Brain Centre (NEAD) Frederiksberg Capital Region of Denmark

Summary

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.

Eligibility Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07920302). StuddyBuddy aggregates publicly available trial information.