Affective Cognitive Training for mood disorders and their close relatives

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study tests a six-week targeted affective cognitive training delivered with virtual reality and computer-based tasks in adults with major depressive disorder or bipolar disorder who are in partial or full remission, plus their unaffected first-degree relatives. Participants are randomized to receive the training plus treatment as usual or treatment as usual alone, with the goal of improving affective cognition such as emotion regulation and facial emotion recognition. Outcomes include changes in emotion regulation, neural activity in emotion-related brain areas, broader cognitive functioning, psychosocial functioning, quality of life, and long-term clinical outcomes. Recruitment is from the Copenhagen area, with a plan to enroll up to 100 participants to obtain complete data from 80. Baseline assessments cover affective and non-affective cognitive domains, and eligibility requires mood disorder diagnosis with emotion regulation difficulties and Danish language fluency.

Why it matters

Who can join: the full rules

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

Where it's running

• Neurocognition and Emotion Across Disorders Brain Centre (NEAD)
  Frederiksberg, Capital Region of Denmark, Denmark Recruiting

Study contacts

• Study coordinator: Astrid Endrup Iversen, PhD student
• Email: astrid.endrup.iversen@regionh.dk
• Phone: +4520461323

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.