An Intervention Study of Anhedonia and Pain Empathy in Depression

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

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

Study Overview

• Status: Recruiting
• Conditions: Treatment Resistant Depression; Problem Management Plus; Event-Related Potentials
• Intervention / Treatment: Behavioral: PM+

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).

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kongliang He, MD; Phone Number: 0086055113966721862; Email: hefei413@163.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230032
      • Recruiting
      • Anhui Medical University
      • Contact: Fengqiong Yu, MD; Email: yufengqin1@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group PM+; Intervention once a week for a total of 5 weeks	Behavioral: 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)
NO_INTERVENTION: control group; Just daily observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Patient Health Questionnaire	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.	baseline;5 weeks post-treatment
Change from baseline in Temporal Experience of Pleasure Scale	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) .	baseline;5 weeks post-treatment
Change from baseline in Toronto Alexithymia Scale	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.	baseline;5 weeks post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change from baseline in behavioral results of Incentive Delay task	The amplitudes of brain potentials of assessed by eventrelated brain potentials methods change from baseline after the treatment.	baseline; 5 weeks post-treatment change from baseline after the treatment
The change from baseline in event-related brain potentials during Pain empathy task	The amplitudes of brain potentials of assessed by eventrelated brain potentials methods change from baseline after the treatment.	baseline; 5 weeks post-treatment change from baseline after the treatment

Collaborators and Investigators

• Sponsor: Anhui Medical University
• Investigators: Study Chair: Wang Kai, MD, Anhui Medical University; Study Director: Kongliang He, MD, Anhui Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2022
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (ACTUAL): May 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Nervous System Diseases; Mood Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Depression; Depressive Disorder; Anhedonia; Depressive Disorder, Treatment-Resistant
• Other Study ID Numbers: Y&H

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No