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临床试验/NCT03995186
NCT03995186已完成不适用

Effects of Behavioural Activation on Emotional Cognition and Mood

University of Oxford2 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2019年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
97
试验地点
2
主要终点
Change in recognition of positive and negative facial expressions from baseline at week 2 and 4

研究概览

简要总结

Behavioural activation (BA) is widely accepted as an efficacious treatment for depression. It has been suggested that several depression treatments work via early changes in emotional processing (e.g. affective bias in the processing of facial expressions) and that these could help predict treatment success, but it has not yet been examined whether the same applies in behavioural interventions. The investigators will examine how BA affects early emotional information processing in participants who are currently experiencing low mood, to see whether this can predict eventual changes in mood and to gain a better understanding of the treatment mechanisms of BA. Participants will be in three groups undergoing either behavioural activation, or activity monitoring alone (active control) for 4 weeks, or they will be on a waiting list (passive control). The investigators will also examine whether other factors, such as anxiety, social support and environmental reward, can predict the success of BA. This could help us understand how BA works and who may be most suitable for this intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Female or male
  • Age: 18 to 65 years
  • Competency to give informed consent
  • Scores above 14 on BDI-2 (bottom criterion for mild depression)

排除标准

  • Previous participation in a study that used the emotional test battery (ETB)
  • Currently undergoing any form of psychotherapy or counselling
  • Taking antidepressant medication for less than 3 months, or changing existing psychiatric medication within the past month
  • Current or past a diagnosis of psychosis or a bipolar disorder
  • Current diagnosis of an eating disorder, a borderline personality disorder, or a substance abuse disorder
  • Any other factor that would indicate the participant isn't able to comply with the requirements of the study according to the opinion of the chief investigator (severe insomnia, chronic fatigue syndrome, neurological conditions impairing cognitive function etc.)
  • Symptoms of depression are too severe (score 20 and above on the PHQ-9 questionnaire or according to the evaluation of study psychiatrist)

结局指标

主要结局

Change in recognition of positive and negative facial expressions from baseline at week 2 and 4

时间窗: Will be assessed at week 0, week 3 and week 5 of the intervention

Hit rate for detecting positive versus negative faces in a facial expression recognition task (FERT)

次要结局

  • Change in mood(Will be assessed at week 0, week 3 and week 5 of the intervention)
  • Change in environmental reward(Will be assessed at week 0, week 3 and week 5 of the intervention)
  • Motor activity(5 weeks)
  • Change in reward sensitivity(Will be assessed at week 0, week 3 and week 5 of the intervention)
  • Change in levels of behavioural activation(Will be assessed at week 0, week 3 and week 5 of the intervention)
  • Change in subjective experience of social support(Will be assessed at week 0, week 3 and week 5 of the intervention)
  • Change in anxiety(Will be assessed at week 0, week 3 and week 5 of the intervention)
  • Change in speed during recognition of positive and negative facial expressions(Will be assessed at week 0, week 3 and week 5 of the intervention)
  • Change in emotional categorisation (ECAT)(Will be assessed at week 0, week 3 and week 5 of the intervention)
  • Change in recall in the Emotional memory task (EREC)(Will be assessed at week 0, week 3 and week 5 of the intervention)
  • EREC as a possible predictor of mood change(Will be assessed at week 3 and week 5 of the intervention)
  • Median scores on the daily Mood Zoom questionnaire(5 weeks)
  • Change in performance on Auditory Verbal Learning Task (AVLT)(Will be assessed at week 0, week 3 and week 5 of the intervention)
  • ECAT as a possible predictor of mood change(Will be assessed at week 3 and week 5 of the intervention)
  • FERT as a possible predictor of mood change(Will be assessed at week 3 and week 5 of the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Catherine Harmer

Professor

University of Oxford

研究点 (2)

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