An Intervention Study of Anhedonia and Pain Empathy in Depression

NCT ID: NCT05355142

Last Updated: 2022-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-06-01

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).

Conditions

Treatment Resistant Depression; Problem Management Plus; Event-Related Potentials

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group PM+

Intervention once a week for a total of 5 weeks

Group Type: EXPERIMENTAL

PM+

Intervention Type: BEHAVIORAL

1 Brief introduction to PM+ & NDA (5 min) Assessment-based review with PSYCHOLOPS (psychopomps psychology ) assessment (10 min) What is PM+ (20 minutes) Understanding Adversity (30 minutes) Stress Management (20 minutes) Closing the meeting (5 minutes)

2 General Review (5 min) Issue management (70 minutes) Stress management (10 minutes) Closing the meeting (5 minutes)

3 General Review (5 minutes) Problem Management (35 minutes) Take action and be consistent (35 minutes) Stress management (10 minutes) Closing the meeting (5 minutes)

4 General Review (5 minutes) Issue Management (20 minutes) Take action and be persistent (20 minutes) Strengthening Social Support (30 minutes) Stress management (10 minutes) Closing the meeting (5 minutes)

5 General Review (20 minutes) Staying Healthy (30 minutes) Imagining how to help someone (20 minutes) Looking ahead (15 minutes) Closing the de-briefing (5 minutes)

control group

Just daily observation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PM+

1 Brief introduction to PM+ & NDA (5 min) Assessment-based review with PSYCHOLOPS (psychopomps psychology ) assessment (10 min) What is PM+ (20 minutes) Understanding Adversity (30 minutes) Stress Management (20 minutes) Closing the meeting (5 minutes)

2 General Review (5 min) Issue management (70 minutes) Stress management (10 minutes) Closing the meeting (5 minutes)

3 General Review (5 minutes) Problem Management (35 minutes) Take action and be consistent (35 minutes) Stress management (10 minutes) Closing the meeting (5 minutes)

4 General Review (5 minutes) Issue Management (20 minutes) Take action and be persistent (20 minutes) Strengthening Social Support (30 minutes) Stress management (10 minutes) Closing the meeting (5 minutes)

5 General Review (20 minutes) Staying Healthy (30 minutes) Imagining how to help someone (20 minutes) Looking ahead (15 minutes) Closing the de-briefing (5 minutes)

Intervention Type: BEHAVIORAL

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Medical University

OTHER

Sponsor Role: lead

Responsible Party

Fengqiong Yu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wang Kai, MD

Role: STUDY_CHAIR

Anhui Medical University

Fengqiong Yu, MD

Role: STUDY_DIRECTOR

Anhui Medical University

Kongliang He, MD

Role: STUDY_DIRECTOR

Anhui Medical University

Locations

Anhui Medical University

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fengqiong Yu, MD

Role: CONTACT

yufengqin1@163.com

0086055115955155423

Kongliang He, MD

Role: CONTACT

hefei413@163.com

0086055113966721862

Facility Contacts

Fengqiong Yu, MD

Role: primary

yufengqin1@163.com

Other Identifiers

Y&H

Identifier Type: -

Identifier Source: org_study_id