Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05355142 |
| Other study ID # |
Y&H |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2022 |
| Est. completion date |
June 1, 2023 |
Study information
| Verified date |
May 2022 |
| Source |
Anhui Medical University |
| Contact |
Fengqiong Yu, MD |
| Phone |
0086055115955155423 |
| Email |
yufengqin1[@]163.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Brain Network Mechanism of Pain Empathy and Anhedonia in Patients With Depression by Group
Problem Management Plus Intervention.
Description:
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.
3.2 Experimental paradigm of pain empathy In the experiment, the screen first presents a
400ms "+" fixation point, then presents a 400ms empty screen, and then presents a 1000ms
picture stimulus. After the stimulus is presented, the empty screen is 1500 ~ 1700ms.
The experiment consists of two tasks: ① pain judgment task, which requires subjects to
judge whether the body owner in the picture will feel pain ② Left right judgment task:
the task requires the subjects to distinguish the left and right limbs in the picture.
The subjects also need to watch the picture carefully and make a judgment as quickly and
accurately as possible。
4. PM + (problem management plus) intervention is a psychological intervention of 1.5 hours
each time for five weeks. Four strategies are mainly taught so that students can use
them in daily life. PM + includes four core strategies: (1) decompression (breathing
relaxation, mindfulness, etc.); (2) Problem management (coping strategies for practical
problems); (3) Act by words, persevere, and emphasize behavior activation (mainly for
the strategy of withdrawal of depressive behavior); (4) Strengthen interpersonal
relationships (emphasis on strengthening interpersonal connections).
