An Intervention Study of Anhedonia and Pain Empathy in Depression

NCT05355142 | Unknown DMC

• 1 other identifier: Y&H
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• The change from baseline in behavioral results of Incentive Delay task

  baseline; 5 weeks post-treatment change from baseline after the treatment

• The change from baseline in event-related brain potentials during Pain empathy task

  baseline; 5 weeks post-treatment change from baseline after the treatment

Study Arms (2)

Group PM+

EXPERIMENTAL

Intervention once a week for a total of 5 weeks

Behavioral: PM+

control group

NO INTERVENTION

Just daily observation

Interventions

PM+ 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)

Group PM+

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Anhui Medical University

Hefei, Anhui, 230032, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Wang Kai, MD

  Anhui Medical University

  STUDY CHAIR

• Fengqiong Yu, MD

  Anhui Medical University

  STUDY DIRECTOR

• Kongliang He, MD

  Anhui Medical University

  STUDY DIRECTOR

Central Study Contacts

Fengqiong Yu, MD

CONTACT

0086055115955155423; yufengqin1@163.com

Kongliang He, MD

CONTACT

0086055113966721862; hefei413@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: May 2, 2022
• Study Start: April 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: May 6, 2022

Record last verified: 2022-05

Locations

CN (1)