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临床试验/NCT05355142
NCT05355142Unknown不适用

Brain Network Mechanism of Pain Empathy and Anhedonia in Patients With Depression by Group Problem Management Plus Intervention

Anhui Medical University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2022年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
66
试验地点
1
主要终点
Change from baseline in Temporal Experience of Pleasure Scale

研究概览

简要总结

Brain Network Mechanism of Pain Empathy and Anhedonia in Patients With Depression by Group Problem Management Plus Intervention.

详细描述

It is expected to collect 66 college students.

  1. Depressed college students;Healthy control:

Inclusion criteria: 1) college students; 2) PHQ-9 > 4 points; 2) After informing the content of the study, agree to join the study, sign the informed consent form and accept relevant examination; 3) No major physical diseases in the past; Exclusion criteria: 1) lack of basic data; 2) Those who are currently diagnosed with depression and receiving psychotherapy; 3) Those who are unwilling to accept the inspection and quit halfway; 4) History of brain trauma, or accompanied by serious physical diseases, such as heart and liver dysfunction; 2. Scale evaluation:

2.1 background information: gender, age, years of education, marriage and childbirth, place of residence (urban and rural), family economic situation (poor, general and good), family structure (core, single parent, reorganization and separation), self-rated learning pressure (high, general and low), whether he is an only child and whether he is a class cadre, etc.

2.2 depression assessment: Depression Screening Scale (PHQ-9), 2.3 symptom evaluation of loss of pleasure: time experience pleasure scale (TEPS); Loss of social pleasure (RSAs) 2.4 UCLA Loneliness Scale; TAS Alexithymia Scale; Chinese version of interpersonal response index scale (IRI) 3. Experimental paradigm was measured before and after psychological intervention 3.1 Intensive delay First, the subjects were presented with a signal indicating that the cue was 400ms. After cue, the fixation point was 2250-2750 MS, and then the target stimulus square appeared. The presentation time was 160 ms to 260 Ms. The subjects are required to respond to the target stimulation key at the fastest speed. The time of random presentation of fixation is 1450ms. The feedback signal is given according to the results of the subjects' key response, and the presentation time is 1650ms. Finally, the fixation point was presented for 1200-1500ms; The whole paradigm includes two types of reward tasks; One is monetary reward and the other is social reward. Each task consists of 88 trials, resulting in a total of 176 trials.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • College students;
  • PHQ-9 > 4 points;
  • After informing the content of the study, agree to join the study, sign the informed consent form and accept relevant examination;
  • No major physical diseases in the past;

排除标准

  • Lack of basic data;
  • Those who are currently diagnosed with depression and receiving psychotherapy;
  • Those who are unwilling to accept the inspection and quit halfway;
  • History of brain trauma, or accompanied by serious physical diseases, such as heart and liver dysfunction;

研究组 & 干预措施

Group PM+

Experimental

Intervention once a week for a total of 5 weeks

干预措施: PM+ (Behavioral)

control group

No Intervention

Just daily observation

结局指标

主要结局

Change from baseline in Temporal Experience of Pleasure Scale

时间窗: baseline;5 weeks post-treatment

The Temporal Experience Pleasure Scale consists of anticipatory (TEPS-anti) and consummatory anhedonia subscales (TEPS-con) with lower scores indicating stronger anhedonia propensity. The Chinese version has demonstrated high internal consistence (Cronbach's alpha = 0.84) .

Change from baseline in Patient Health Questionnaire

时间窗: baseline;5 weeks post-treatment

The four-level scoring of the PHQ-9 Depression Screening Scale, consisting of nine items with a total score of 0-27, where 0-4 is no depression, 5-9 may have mild depression, 10-14 may have moderate depression, 15-19 may have moderate to severe depression, and 20-27 may have severe depression, has proven validity for application in Chinese adult and college student populations with an internal consistency coefficient of 0.854 and a retest reliability of 0.873.

Change from baseline in Toronto Alexithymia Scale

时间窗: baseline;5 weeks post-treatment

The TAS developed by Taylor et al. in 1994 was used, with 20 items on a 5-point scale ranging from "totally disagree" to "totally agree". The scale contains three factors, namely, Disorders of Affective Identification (DIF), Disorders of Descriptive Affect (DDF), and Extraverted Thinking, and the TAS was tested for high reliability and validity.

次要结局

  • The change from baseline in behavioral results of Incentive Delay task(baseline; 5 weeks post-treatment change from baseline after the treatment)
  • The change from baseline in event-related brain potentials during Pain empathy task(baseline; 5 weeks post-treatment change from baseline after the treatment)

研究者

发起方
Anhui Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fengqiong Yu

Associate Professor

Anhui Medical University

研究点 (1)

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