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An Intervention Study of Anhedonia and Pain Empathy in Depression

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PM+
Sponsored by
Anhui Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Resistant Depression

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Anhui Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group PM+

control group

Arm Description

Intervention once a week for a total of 5 weeks

Just daily observation

Outcomes

Primary Outcome Measures

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.
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) .
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 18, 2022
Last Updated
May 3, 2022
Sponsor
Anhui Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05355142
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Anhui Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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. 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; 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) 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。 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression, Problem Management Plus, Event-Related Potentials

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group PM+
Arm Type
Experimental
Arm Description
Intervention once a week for a total of 5 weeks
Arm Title
control group
Arm Type
No Intervention
Arm Description
Just daily observation
Intervention Type
Behavioral
Intervention Name(s)
PM+
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change from baseline in Patient Health Questionnaire
Description
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.
Time Frame
baseline;5 weeks post-treatment
Title
Change from baseline in Temporal Experience of Pleasure Scale
Description
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) .
Time Frame
baseline;5 weeks post-treatment
Title
Change from baseline in Toronto Alexithymia Scale
Description
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.
Time Frame
baseline;5 weeks post-treatment
Secondary Outcome Measure Information:
Title
The change from baseline in behavioral results of Incentive Delay task
Description
The amplitudes of brain potentials of assessed by eventrelated brain potentials methods change from baseline after the treatment.
Time Frame
baseline; 5 weeks post-treatment change from baseline after the treatment
Title
The change from baseline in event-related brain potentials during Pain empathy task
Description
The amplitudes of brain potentials of assessed by eventrelated brain potentials methods change from baseline after the treatment.
Time Frame
baseline; 5 weeks post-treatment change from baseline after the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fengqiong Yu, MD
Phone
0086055115955155423
Email
yufengqin1@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kongliang He, MD
Phone
0086055113966721862
Email
hefei413@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang Kai, MD
Organizational Affiliation
Anhui Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fengqiong Yu, MD
Organizational Affiliation
Anhui Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kongliang He, MD
Organizational Affiliation
Anhui Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fengqiong Yu, MD
Email
yufengqin1@163.com

12. IPD Sharing Statement

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An Intervention Study of Anhedonia and Pain Empathy in Depression

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