Gambling Clinical Trial
Official title:
Effects of Positive Psychological Group Psychotherapy and Auricular Acupressure on Gambling Severity, Withdrawal Symptoms, and Dopamine
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.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | February 28, 2026 |
Est. primary completion date | February 28, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years and older |
Eligibility | [For first-year]: Inclusion Criteria: 1. 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 2. 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 - never been blacked out in their lives - had negative outcome in cotinine urine tests - had no medical or psychological diagnosis - no medication for therapeutic purposes Exclusion Criteria: 1. gamblers who - were pregnant - had experiences in taking drugs, including marijuana. 2. 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]: Inclusion Criteria: 1. gamblers - will be the same as those in the first year of the study. Exclusion Criteria: 1. 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Inha University Hospital | Incheon |
Lead Sponsor | Collaborator |
---|---|
Inha University Hospital | National Research Foundation of Korea |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Patient Health Questionnaire-9 | This is a tool for measuring depression and comprises a total of nine questions. In order to find out if you have experienced depression-related problems often in the past two weeks. The score based on that zero is "none at all", one score is "three to four days", two score is "eight to ten days", three scores are "12 to 14 days", and the score is 0 to 27 and consists of a four-point scale. If the total score is more than 10 points, it is judged to have depression. In a study of 167 normal people and depressed subjects, the Chronbach's alpha coefficient was .936 and showed a high correlation with the Korean version of the Center for Epidemiological Studies Depression Scale (r=.706). | baseline, 6 weeks, 6 months, 1 year | |
Secondary | Resilience | This scale is an individual's inner capacity, which includes a dynamic process of heading in a more positive direction in the stress and crisis situations that an individual perceives as adversity.The 31-question tool is a four-point scale, ranging from one "not at all" to four "very much" points, with a range ranging from a minimum of 31 to a maximum of 124. The higher the score, the higher the resistance. And at the time of development, Cronbach's alpha was .85. | baseline, 6 weeks, 6 months, 1 year | |
Secondary | Korean Version of Gratitude Questionnaire | This tool was developed by McCullow and colleagues, and Korean Version of Gratitude Questionnaire (K - GQ - 6), which obtained reliability and validity, was measured using the Likert 7-point scale. Specifically, the scale consists of six questions: "There are so many things to be thankful for in my life," "If I list all the things I've appreciated so far," "There's not much to be thankful for in the world," "I'm grateful for many people," "I've never been more grateful for things." A single factor accounted for 56.9% of the total variations. | baseline, 6 weeks, 6 months, 1 year | |
Secondary | Korean Forgiveness Scale-Short Form | This form was developed by Young-hee Oh and consists of 10 questions, 4 questions that measure emotional response, 2 questions that measure cognitive response, and 4 questions that measure behavioral response. It consists of a five-point scale from 1 point "minimum" to 5 point "excessive". The range of forgiveness points is 10-50, and the higher the forgiveness score, the more forgiveness. In a study of adults, the question-to-question consistency (Cronbach's alpha) was .86, and the test-to-retest reliability for 95 college students was .78. Exploratory factor analysis and confirmatory factor analysis to determine compositional validity have shown that it is appropriate to view as one factor (explanatory variable 44.80%). | baseline, 6 weeks, 6 months, 1 year | |
Secondary | Korea Version of Alcohol Use Disorder Identification Test | Geun-ho Cho used a tool developed by the World Health Organization (WHO) that was adapted from the Alcohol Use Disorder Identification Test(AUDIT). There are a total of 10 questions, and questions 1-8 consist of 0 to 4 points on a 5-point scale, and questions 9 and 10 score 0, 2, 4 on three scales. In Cho Geun-ho's study, the test-retest reliability was reported to be 0.93, significantly correlated with the amount of alcohol in a standard glass and the AUDIT-K score, indicating high feasibility (r=0.66 and p<0.01). | baseline | |
Secondary | Korean Smartphone Addiction Proneness Scale for Adults | The smartphone addiction measure was developed by National Information Society Agency in 2011. A total of 15 questions consist of four subcategories: "Daily Life Disorder", "Virtual World Experience Orientation", "Resistance", "tolerance" and "withdrawal", the score scale consists of a four-point scale from "Never" to "Excessive". The reliability Cronbach's alpha value was shown to be .81. | baseline | |
Secondary | Korean version of Nicotine Dependence Syndrome Scale | The nicotine-dependence syndrome scale developed by Shiffman and his colleagues (2004) was translated by Jae-woo Park(2007). As a result, it consists of 23 questions, and one point means "extremely severe" and five points means "not at all" on a five-point scale. A study of 274 health center smoking clinic participants showed confidence (internal value) of .66-90 and 8 factors in factor analysis, and 58.3% random variables described as 8 factors (Park Jae-woo, 2007). | baseline | |
Secondary | Eysenck Personality Inventory | This is a test that measures nine major personality dimensional factors: psychotic tendency, extroversion-introversion, adventure, impulsiveness, falseness, addiction, criminality, neurological tendency, and empathy. It consists of 121 questions, each of which is based on true and false. If the standardized T score is higher than 50, it can be interpreted as having higher scores than people of the same race and age. The Cronbach's Alpha on each scale obtained during the standardization process for Koreans was 0.65-0.87. | baseline | |
Secondary | Urine Cotinine Test | Cotinine urine tests will be conducted to identify non-smoking standards, which include normal groups. When smoking, nicotine is absorbed and metabolized into the body and released into urine, among which cotinine, the main metabolite, is increased in the body. The half-life of cotinine in the body is 17 hours. The manufacturer of the cotinine urine test kit to be used in the study is Hangzhou Clongene Biotech Co., Ltd., originating in China. The minimum sample amount for testing is 110microliter (3 drops) and the cut-off point is 200ng/ml. Urine tests can be traced up to 7-10 days. | baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT02862821 -
Biomarkers of Online Gambling Addiction
|
N/A | |
Completed |
NCT00967005 -
N-Acetyl Cysteine Plus Behavioral Therapy for Nicotine Dependent Pathological Gamblers
|
Phase 2 | |
Withdrawn |
NCT00370188 -
Topiramate on Gambling-Related Behaviours
|
Phase 2 | |
Completed |
NCT00069420 -
Cognitive Motivational Behavior Therapy for Gamblers
|
Phase 1 | |
Completed |
NCT02841566 -
Comparative Study of the Link Between the Practice of Gambling and Money and Materialism Among Problem Gamblers and Non-problem Gamblers
|
N/A | |
Not yet recruiting |
NCT05630157 -
Evaluation of Effectiveness of the Unplugged Program on Gambling Among Adolescents (GAPUnplugged)
|
N/A | |
Completed |
NCT00118391 -
Cognitive-Behavioral Treatment of Gambling
|
Phase 1 | |
Completed |
NCT03323606 -
Online Interventions for Gamblers With and Without Co-occurring Problem Drinking
|
N/A | |
Completed |
NCT01219426 -
A Transversal Study for the French Validation of Two Assessment Tools of Gambling Related Cognitions.
|
N/A | |
Completed |
NCT00158314 -
Cognitive Behavioral Therapy for Treatment of Pathological Gambling
|
Phase 1 | |
Completed |
NCT02250586 -
Internet Based Cognitive Behavior Therapy for Concerned Significant Others of Problem Gamblers
|
N/A | |
Completed |
NCT02800096 -
Online Interventions for Gamblers With and Without Co-occurring Mental Health Concerns
|
N/A | |
Completed |
NCT00685048 -
Brief Therapies for Problem Gambling Substance Abusers
|
N/A | |
Completed |
NCT00078273 -
Indicated Prevention With At-Risk Gamblers
|
Phase 2 | |
Recruiting |
NCT05933356 -
Effectiveness of Exergames on Cognitive, Social Functionamong Chronic Schizophrenia
|
N/A | |
Not yet recruiting |
NCT03493399 -
Testing Interference-based Methods to Mitigate Gambling Craving - A Multiple Single Case Design
|
N/A | |
Not yet recruiting |
NCT06171516 -
Internet-based Cognitive Behavioral Therapy for Individuals With Gambling Disorder in Indonesia
|
N/A | |
Recruiting |
NCT06195995 -
Brain Mechanism and Intervention of Executive-control Dysfunction Among Gambling Disorder
|
N/A | |
Recruiting |
NCT06341504 -
Prevention Messages for EGMs: Effects on Behaviours and Cognitions
|
N/A | |
Completed |
NCT02771886 -
Evaluation of a Brief Surf the Urge Intervention
|
N/A |