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临床试验/NCT02613104
NCT02613104撤回不适用

Emotion Recognition Modification for Bipolar Disorder

Northwell Health1 个研究点 分布在 1 个国家开始时间: 2014年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
change in face emotion recognition as assessed by the number of face emotions correctly identified

研究概览

简要总结

Previous research suggests that people with bipolar disorder have trouble accurately identifying emotions. The goal of this study is to test a novel intervention, emotion recognition modification (ERM), to help improve the ability of young people with bipolar disorder to identify emotions.

详细描述

Procedure: Participants will be recruited through the University Clinic, affiliated psychiatric hospitals and outpatient psychiatric clinics in the area, and public websites. Interested participants will be interviewed on the phone to determine initial eligibility; those who meet criteria will be invited for a comprehensive evaluation.

For potential participants under the age of 18, parents/caregivers will be asked the eligibility questions about their child. If the child meets initial eligibility criteria, both s/he and the parent/caregiver will be invited to the baseline appointment.

The baseline appointment will take place at Zucker Hillside Hospital. Following the informed consent/assent process, participants will be interviewed by a trained research assistant to assess clinical and treatment history, and to determine diagnostic eligibility, using the SCID. Participants who meet eligibility criteria will proceed to complete other baseline measures.

Emotion recognition baseline procedure. The baseline task allows for the measurement of each participants' baseline balance point, the point at which they are equally likely to see a given face as happy or sad (or angry). Each participant will complete 45 trials of the emotion recognition task in which each face from a morph sequence of happy and sad (or angry) faces is presented, the participant is then forced to decide whether a face is sad (or angry) or happy.

Intervention: Once the baseline measures are completed, participants will be randomized to the sad-to-happy condition, the angry-to-happy condition, or a control condition (n =20 per group). Participants in the intervention conditions will complete the training task three times over three in-person sessions. The task will be similar to the baseline procedure; participants will view faces and be asked to judge the expression, however they will now be given feedback (e.g. "Incorrect! That face was happy."), in order to shift the category of happy faces to include those faces two morph steps beyond the participant's baseline balance point. Participants in the control condition will repeat the baseline task, with feedback consistent with their baseline performance (i.e. the faces they judged as happy initially will be called "correct" when judged happy again. The intervention will be administered a total of three times (once at baseline, once at the first follow-up, once at the second follow-up).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
16 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged 16-25 with a bipolar spectrum disorder. Must be English-speaking.

排除标准

  • •Participants who have cognitive impairment, current psychosis, current suicidal intent, or current substance use disorder will be excluded.

研究组 & 干预措施

Sad to Happy

Experimental

emotion recognition modification - sad>happy

干预措施: emotion recognition modification - sad>happy (Other)

Sad control

Placebo Comparator

emotion recognition modification - sad>happy control

干预措施: emotion recognition modification - sad>happy control (Other)

Angry to Happy

Experimental

emotion recognition modification - angry>happy

干预措施: emotion recognition modification - angry>happy (Other)

Angry control

Placebo Comparator

emotion recognition modification - angry>happy control

干预措施: emotion recognition modification - angry>happy control (Other)

结局指标

主要结局

change in face emotion recognition as assessed by the number of face emotions correctly identified

时间窗: two months after the completion of the intervention

Ratio of faces identified as happy versus sad/angry

次要结局

  • change in self reported depressed mood as measured by baseline and post intervention(following three sessions of the intervention (approximately two weeks))
  • change in positive affect as measured by the Positive and Negative Affect Scale(following three sessions of the intervention (approximately two weeks))
  • change in self-reported depressed mood as measured by baseline and two month follow-up scores(two months after completion of intervention)
  • change in clinician-rated depressed mood as measured by baseline and two month follow-up scores(two months after completion of intervention)
  • change in social functioning as measured by the social network questionnaire(following three sessions of the intervention (approximately two weeks))
  • change in social functioning as measured by the social network questionnaire at follow-up(two months after completion of intervention)
  • change in clinician-rated depressed mood as measured by baseline and post intervention scores o(following three sessions of the intervention (approximately two weeks))
  • change in positive affect as measured by the Positive and Negative Affect Scale at follow-up(two months after completion of intervention)

研究者

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

Anna Van Meter

Assistant Professor

Northwell Health

研究点 (1)

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