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

2026年10月30日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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).

研究の種類

介入

入学 (推定)

100

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • デンマーク
    • Capital Region of Denmark
      • Frederiksberg、Capital Region of Denmark、デンマーク、2000
        • 募集
        • Neurocognition and Emotion Across Disorders Brain Centre (NEAD)
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～60年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
介入なし：通常通りの治療
実験的：Targeted affective cognitive training
行動：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Affective cognitive composite measure
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Dorsal prefrontal cortex activity during emotion regulation
時間枠：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)
時間枠：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)

その他の成果指標

結果測定
メジャーの説明
時間枠
VERA
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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"
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：Baseline and week 7 (treatment completion)

Questionnaire on habitual emotion regulation strategies.
Baseline and week 7 (treatment completion)
Attentional Control Scale
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline and week 7 (treatment completion)

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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年11月17日

一次修了 (推定)

2027年10月31日

研究の完了 (推定)

2029年10月1日

試験登録日

最初に提出

2026年10月30日

QC基準を満たした最初の提出物

2026年10月30日

最初の投稿 (実際)

2026年11月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月5日

QC基準を満たした最後の更新が送信されました

2026年10月30日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • H-25024438
  • p-2025-18973 (その他の識別子：Danish Data Protection Agency)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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