Clinical trial NCT05355142: An Intervention Study of Anhedonia and Pain Empathy in Depression
Official title: Brain Network Mechanism of Pain Empathy and Anhedonia in Patients With Depression by Group Problem Management Plus Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Treatment Resistant Depression
Problem Management Plus
Event-Related Potentials
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

Detailed 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).

Eligibility criteria: Inclusion Criteria:

1. College students;
2. PHQ-9 \> 4 points;
3. After informing the content of the study, agree to join the study, sign the informed consent form and accept relevant examination;
4. 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;

Primary outcomes:
measure: Change from baseline in Patient Health Questionnaire
timeFrame: baseline;5 weeks post-treatment
measure: Change from baseline in Temporal Experience of Pleasure Scale
timeFrame: baseline;5 weeks post-treatment
measure: Change from baseline in Toronto Alexithymia Scale
timeFrame: baseline;5 weeks post-treatment
Secondary outcomes:
measure: The change from baseline in behavioral results of Incentive Delay task
timeFrame: baseline; 5 weeks post-treatment change from baseline after the treatment
measure: The change from baseline in event-related brain potentials during Pain empathy task
timeFrame: baseline; 5 weeks post-treatment change from baseline after the treatment
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Medical University
state: Anhui
Study officials:
affiliation: Anhui Medical University
name: Wang Kai, MD
role: STUDY_CHAIR
affiliation: Anhui Medical University
name: Fengqiong Yu, MD
role: STUDY_DIRECTOR
affiliation: Anhui Medical University
name: Kongliang He, MD
role: STUDY_DIRECTOR
References: