CClinicalTrials.gg
Status unknownNCT05355142Updated May 6, 2022

An Intervention Study of Anhedonia and Pain Empathy in Depression

An interventional study of PM+ in Treatment Resistant Depression, Problem Management Plus and Event-Related Potentials, sponsored by Anhui Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2022-05-06.

Sponsored by Anhui Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study summary

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

Read the 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).
02

Conditions studied

  • Treatment Resistant Depression
  • Problem Management Plus
  • Event-Related Potentials
03

In context

Anhedonia

119 studies on the registry are indexed under Anhedonia; 44 are open to participants now.

This study's planned enrollment of 66 is close to the median of 70 across 99 interventional studies indexed under Anhedonia.

Browse Anhedonia studies →

Lead sponsor

Anhui Medical University is the lead sponsor of 102 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
66 participants (estimated)

Study arms

  • Experimental
    Group PM+

    Intervention once a week for a total of 5 weeks

    Behavioral: PM+

  • No intervention
    control group

    Just daily observation

Interventions

  • BehavioralPM+

    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)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline;5 weeks post-treatment

  2. 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) .

    Time frame: baseline;5 weeks post-treatment

  3. 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.

    Time frame: baseline;5 weeks post-treatment

Secondary outcomes

  1. 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.

    Time frame: baseline; 5 weeks post-treatment change from baseline after the treatment

  2. 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.

    Time frame: baseline; 5 weeks post-treatment change from baseline after the treatment

07

Study locations

1 of 1 sites recruiting
  • Anhui Medical University
    Hefei, Anhui 230032, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05355142
Lead sponsor
Anhui Medical University
Responsible party
Fengqiong Yu (Associate Professor, Anhui Medical University) — Principal investigator
First posted
May 2, 2022
Start date
Apr 1, 2022
Primary completion
Dec 1, 2022 (estimated)
Completion
Jun 1, 2023 (estimated)
Last update
May 6, 2022

Study contacts

Fengqiong Yu, MD
Contact
yufengqin1@163.com
0086055115955155423
Kongliang He, MD
Contact
hefei413@163.com
0086055113966721862
Wang Kai, MD
study chair · Anhui Medical University
Fengqiong Yu, MD
study director · Anhui Medical University
Kongliang He, MD
study director · Anhui Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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