NCT05241041

Brief Summary

Objective The purpose of this study is to examine the effects of auricular acupressure and group counseling with positive psychology on gambling severity, withdrawal symptoms, and dopamine. Methods This study is a randomized controlled trial and has been performed at a University in South Korea. 180 gamblers and 60 non-gamblers will be recruited. In the first year, gamblers will be randomly assigned to two groups: Experimental Group 1 (auricular acupressure); and Control Group 1 (education material to stop and cope withdrawal symptoms). And Normal Group will be recruited independently. Furthermore, a single blind randomized controlled trial will be performed in second and third year. And gamblers will be randomly assigned to three groups: Experimental Group 2 (auricular acupressure + group counseling); Placebo Group (placebo acupressure + group counseling); and Control Group 2 (education material to stop and cope withdrawal symptoms). Auricular acupressure using acupellets is performed for 6 weeks continuously.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 13, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2025

Completed
Last Updated

March 27, 2026

Status Verified

April 1, 2025

Enrollment Period

4 years

First QC Date

December 14, 2021

Last Update Submit

March 23, 2026

Conditions

Gambling

Keywords

group counselingacupressureserotonindepressive symptomsresilience

Outcome Measures

Primary Outcomes (3)

  • Change from Problem Gambling Severity during 1 year

    a tool used to identify gambling addiction, with a score range of 0-27 on the Likert scale of 9 questions which require a score of 0-3. The higher the score, the more serious the gambling addiction. Scores 1-2 are classified as low risk, 3-7 as medium risk, and 8 or more as problematic gambling.

    baseline, 6 weeks, 6 months, 1 year

  • Change from Gambling Withdrawal during 1 year

    Problem Gambling Severity Index was developed based on research into existing gambling withdrawal symptoms.The withdrawal symptoms include 14 items. Zero points have no withdrawal symptoms, one "very little" and two "nominal" and three "normal" and four "very severe". The score is between 0 and 56, and the higher the score, the worse the withdrawal symptoms. Reliability and validity will be checked in this study.

    baseline, 2,3,4,5,6 weeks, 6 months, 1 year

  • Change from serum serotonin/dopamine levels during 6 months

    A suitable sample is EDTA (WB). After calming the subjects for about 30 minutes, collect up to 12ml of peripheral blood through needles. Put the samples in an EDTA sample tube and apply them evenly on the wall of the tube, then centrifuge them for 7 minutes at 3000 rpm. Remove plasma immediately within one hour of collecting blood and store it at a temperature below minus 20 degrees Celsius.

    baseline, 6 weeks, 6 months

Secondary Outcomes (9)

  • Patient Health Questionnaire-9

    baseline, 6 weeks, 6 months, 1 year

  • Resilience

    baseline, 6 weeks, 6 months, 1 year

  • Korean Version of Gratitude Questionnaire

    baseline, 6 weeks, 6 months, 1 year

  • Korean Forgiveness Scale-Short Form

    baseline, 6 weeks, 6 months, 1 year

  • Korea Version of Alcohol Use Disorder Identification Test

    baseline

  • +4 more secondary outcomes

Study Arms (6)

[1st year]Auricular Acupressure Experimental Group 1

EXPERIMENTAL

auricular acupressure

Device: auricular acupressure

[1st year]Control Group 1

NO INTERVENTION

education material

[1st year]Normal Group

NO INTERVENTION

Non-gamblers

[2nd&3rd year]Auricular Acupressure Experimental Group 2

EXPERIMENTAL

auricular acupressure + group counseling

Behavioral: group counselingDevice: auricular acupressure

[2nd&3rd year]Placebo Group

PLACEBO COMPARATOR

placebo acupressure + group counseling

Behavioral: group counselingDevice: placebo acupressure

[2nd&3rd year]Control Group 2

NO INTERVENTION

education material

Interventions

group counselingBEHAVIORAL

Group counseling with positive psychology and motivational interviewing was undertaken once per week for 6 weeks.

[2nd&3rd year]Auricular Acupressure Experimental Group 2[2nd&3rd year]Placebo Group
auricular acupressureDEVICE

Auricular acupressure using acupellets was performed for 6 weeks continuously.

[1st year]Auricular Acupressure Experimental Group 1[2nd&3rd year]Auricular Acupressure Experimental Group 2
placebo acupressureDEVICE

Placebo acupellets were prepared without metal projections, and placed on both sides in the same areas of the ear as the active condition.

[2nd&3rd year]Placebo Group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • gamblers who - are more than 19 years old
  • \- had a total gambling period of more than six months
  • gambled within a month
  • wanted to quit gambling
  • had eight or more PGSI(Problem Gambling Severity Index) scores
  • had no ear infections
  • were not allergic to copper or aluminum
  • willing to complete questionnaires
  • agreed to extract blood
  • non-gamblers who
  • were over the age of 19
  • willing to complete questionnaires
  • agreed to extract blood
  • got zero or received the lowest scores on alcoholism, smartphone addiction, game addiction, and gambling addiction tests
  • had never smoked
  • +4 more criteria

You may not qualify if:

  • gamblers who - were pregnant - had experiences in taking drugs, including marijuana.
  • non-gamblers who
  • were pregnant
  • had taken painkillers in recent a week prior to blood testing
  • had experiences in taking drugs, including marijuana
  • \[For second and third year\]:
  • \. gamblers
  • \- will be the same as those in the first year of the study.
  • \. gamblers who
  • were undergoing gambling counseling
  • were on medication
  • had taken painkillers in the past a week
  • were pregnant
  • had experiences in taking drugs, including marijuana

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inha University Hospital

Incheon, South Korea

Location

MeSH Terms

Conditions

GamblingDepression

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental DisordersBehavioral Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
In the first year, there is no masking to participant and researcher.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 14, 2021

First Posted

February 15, 2022

Study Start

September 13, 2021

Primary Completion

September 28, 2025

Study Completion

September 28, 2025

Last Updated

March 27, 2026

Record last verified: 2025-04

Locations

KR(1)