Clinical trial NCT05241041: Effects of Positive Psychological Group Psychotherapy and Auricular Acupressure on Withdrawal Symptoms
Official title: Effects of Positive Psychological Group Psychotherapy and Auricular Acupressure on Gambling Severity, Withdrawal Symptoms, and Dopamine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gambling
Keywords: group counseling
acupressure
serotonin
depressive symptoms
resilience
Lead sponsor: Inha University Hospital
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2022-02-15
Enrollment: 240
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 1. Introduction The prevalence of gambling addiction is 4% in the U.S., 5.1% in South Korea. Furthermore gambling addiction causes more than 25 trillion in economic deficit annually, suicide and depression, and harmful social effects such as crime and divorce. According to a survey of 105 gambling addicts, 32.4% had depression, which is extremely high compared to 6.7% of the average person's prevalence of depression. Moreovermore, studies show that gambling addicts with depression have a higher level of addiction, childhood trauma experience, and higher nervousness and lower extroversion than those who are without depression. Gambling addicts scored higher than non-gambling addicts in anger. There is a high possibility of combined addiction and 83 studies of 11 addictions showed that gamblers were also addicted to alcohol and drugs about 36-59 percent. Those who had both gambling addiction and alcoholism had lower scores of stubbornness and cooperation compared to those who had only alcoholism. Both groups were anxious and fearful, and tended to pursue new stimuli, with low scores in self-directed areas. Online gambling addicts pursued new stimuli and showed stubborn personality traits compared to non-online gaming addicts.

   Positive psychological mediation is a way to enhance strengths or positive emotions of gratitude, honesty, love, forgiveness, resistance, faith and so on, rather than focusing on the pathological part of the subject. According to an analysis of 22 Korean studies by Nami Kim, positive psychological mediation promoted physical, subjective, psychological and social welfare, and reduced depression, anxiety symptoms, and addiction. Gratitude scores were reported to have a negative correlation with the severity of gambling. The group that wrote five grateful things for two weeks everyday increased positive sentiment, subjective happiness, and decreased negative sentiment and depression compared to the group that recorded negative things or daily life. Forgiveness reduced stresses on self-criticism, resentment and reflection on past mistakes in subjects with drug addiction and suicidal idea. The seven sessions, consisting of forgiveness, gratitude, and recall of life, reduced anxiety and depression. Psychological resilience plays a role in buffering the correlation between gambling addiction and anxiety. Positive psychological intervention has been used to treat alcoholism, internet game addiction, drug addiction, and nicotine addiction, but has never been used to treat gambling addiction.

   Auricular acupuncture is an alternative therapy that stimulates ears using seeds, magnets, stones, and metals. Furthermore, it has been used to treat nicotine and drug addiction, however, research into the problem of gambling has yet to be tried. Gambling subjects who received five weeks of body acupuncture, auricular acupuncture, auricular acupressure and counseling twice a week decreased in thrill-seeking(p=.01), gambling behaviors, ideas and desires, however, there were no statistically significant differences compared to a group who received counseling only (p=.08; effect size=0.64). As a result of applying auricular acupressure and positive psychological group counseling for quitting smoking for six weeks, withdrawal symptoms of experimental groups showed significant decrease compared to a placebo group. After a year, the smoking rate was 22.2 percent in an experimental group, 5.3 percent in a placebo group, and 5.6 percent in a control group.

   And also gamblers experience withdrawal symptoms when gamblers try to quit gamble. To begin with, a study of withdrawal symptoms in 312 gambling addicts found that 25% experienced anxiety/annoyance and 41% experienced anger, guilt and disappointment. After examining the existence of gambling withdrawal symptoms tools for this study, it is believed that it is necessary to develop them and verify reliability and validity by referring to qualitative studies on gambling withdrawal symptoms and previously developed material addiction withdrawal tools.

   Gambling addiction mechanism is as follows. Initially, gambling addiction has been reported to be linked to changes in neurotransmitters such as dopamine, serotonin and opioid. Furthermore, gamblers showed increased performance of dopamine in dynamic positron emission tomography compared to non-gambling addicts. Also, a comparison of problem and non-problem gamblers found that both groups had increased norepinephrine at the beginning of gambling, but maintained an increased norepinephrine throughout the gambling period. Meanwhile, the dopamine level of the problematic gamblers was significantly higher than that of non-problematic ones. Problematic individuals are more impulsive than those who do not have gambling problems, and blood serotonin and impulsiveness are reported to be negatively correlated.

   The auricular acupressure mechanism is as follows. Few studies have used neurotransmitters to see the effects of acupressure, and studies have shown that acupressure has altered serotonin, dopamine, epinephrine, norepine and endorphins. Subsequently, in a rat study, acupuncture for one minute a day for three days reduced alcohol withdrawal symptoms and delayed dopamine levels. Meanwhile, there are studies using self-reported questionnaires to measure the effectiveness of gambling addiction treatments, but there are only a few studies using neurotransmitters.

   The purpose of this study is to examine renouncing gambling, severity of gambling problem, withdrawal symptoms, depression, resistance, appreciation, forgiveness, serum serotonin and dopamine levels compared to those without auricular acupressure or counseling and acupressure services.
2. Method 2.1. Design and setting In the first year, the design of a study is a randomized controlled trial. And in the second and third year, the design of a study is a single blind randomized controlled trial. This study will be conducted at a University in South Korea from September 2021 to February 2025.

2.2. Sample selection Gamblers will be recruited by internet advertisement or face-to-face contacts. All gamblers will be informed about the study protocol, benefits and side effects of interventions, and the right to withdraw from the study at any time without penalty. Gamblers who agree to participate in this study will sign consent forms before data collection. Ethical approval was obtained from the institutional review board in Incheon, South Korea.

2.3. Randomization and single blinding Randomization of numbers is done by random.org to assign a number 1-60. In the first year, the researchers select the second column and a random number is generated. Following this, make a table consisting of two columns, print it out, cut out the individual numbers from the paper and put it in a nontransparent envelope and participants draw numbers from it. The ratio to be deployed to Experimental or Control Group 1 is 1:1. Normal Group is not randomly assigned. In the second and third year, the researcher will select column 3, make a table consisting of three rows, cut out the numbers from the paper, and put it in an envelope that is not visible from the outside. And participants draw numbers from it. The ratio of random assignments to experimental groups, placebo groups, and control groups is 1:1:1. There is no need for allocation of Normal Group because the participans are not recruited.

In the first year, participants will be randomly assigned to one of two groups: Experimental Group 1 (auricular acupressure); Control Group 2 (education material). Experimental and Control Group 1 know about their allocation. In the second and third year, participants will be randomly assigned to one of three groups: Experimental Group 2 (auricular acupressure + group counseling); Placebo Group (placebo acupressure + group counseling); or Control Group 2 (education material). Experimental Group 2 and Placebo Group do not know about their allocation.

2.4. Procedure The researcher will give participants website links of questionnaires to complete. Participants press a finish button to submit questionnaires after completion. All participants who apply acupellets will be instructed not to stimulate themselves with acupellets. Participants will be informed that acupellets would be changed every week, even if the acupellets fell off before the next appointment. Auricular acupressure with acupellets will be performed by the researcher mainly at Sin-moon(TF2), relaxation points (TF6), chim-jeom (LO8), head (AT2), and adrenal glands (TG2) to relieve the withdrawal symptoms on both sides, once per week for 6 weeks. Acupellets are stickers that have copper or aluminum projections. If participants will report an allergy to copper, then acupellets with aluminum projections will be applied; if participants reported an allergy to aluminum, then acupellets with copper projections were applied. If prospective participants are allergic to both copper and aluminum, then the participants will be excluded from the study.

In the second and third year, group counseling and acupressure will be performed by the researcher, who is a psychiatric-mental health nurse practitioner and an acupuncturist. Group counseling consisted of positive psychology and motivational interviewing. Each group consisted of 3-5 participants. Experimental Group 2, Placebo Group will receive group counseling for one hour per week for 6 weeks. Placebo acupellets will be prepared without metal projections, and placed on both sides in the same areas of the ear as the active condition. Auricular acupressure using acupellets will be performed for 6 weeks continuously. Group counseling and auricular acupressure will be undertaken at the same time. Control Group 2 will be encouraged not to gamble without acupressure and psychotherapy.

2.5. Data collection plan At baseline, all participants will complete general characteristics. Health history consists of onset age of gambling, current gambling frequency, amount of losses due to gambling, credit status, health problems, family history related to addiction, quitting gambling attempts, abstinence gambling intentions, and alcohol consumption. And also The Eysenck Personality Questionnaire, The Problem Gambling Severity Index (PGSI), Patient Health Questionnaire-9(PHQ-9), Adult Game Addiction Scale, Adult Smartphone Addict Diagnostic Scale, Nicotine Dependence Syndrome Scale(except Normal Group) will be completed by all participants at baseline.

Participants except Normal Group will complete The Gambling Withdrawal Scale once a week for six weeks.

PHQ-9, Korean Version of Gratitude Questionnaire, The Shortened Forgiveness Scale, Resilience, PGSI will be performed at baseline, 6 weeks, 6 months, and 1 year by Experimental Group 1 and 2, Control Group 1 and 2, and Placebo Group. Except Normal Group, Serotonin/Dopamine in the blood will be collected at baseline, 6 weeks. In Normal Group, Serotonin/Dopamine in the blood will be collected only once at baseline. And lastly, for screening Normal Group, PGSI, Adult Game Addiction Scale, Adult Smartphone Addict Diagnostic Scale, Alcohol Use Disorder Identification Test-Korea(AUDIT-K) and Urine Cotinine Test will be performed at baseline.

2.6. Sample size calculation If the investipagors put t-test, mean difference between two independent means, effect size 1, alpha 0.05, and verification power 95%, the investipagors need 54 people. A total of 60 people are needed considering the dropout rate of 10%. The effect size is 1.3, but the study is scheduled to intervene for six weeks, so the effect size is reduced to 1.

Eligibility criteria: \[For first-year\]:

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

Primary outcomes:
measure: Change from Problem Gambling Severity during 1 year
timeFrame: baseline, 6 weeks, 6 months, 1 year
measure: Change from Gambling Withdrawal during 1 year
timeFrame: baseline, 2,3,4,5,6 weeks, 6 months, 1 year
measure: Change from serum serotonin/dopamine levels during 6 months
timeFrame: baseline, 6 weeks, 6 months
Secondary outcomes:
measure: Patient Health Questionnaire-9
timeFrame: baseline, 6 weeks, 6 months, 1 year
measure: Resilience
timeFrame: baseline, 6 weeks, 6 months, 1 year
measure: Korean Version of Gratitude Questionnaire
timeFrame: baseline, 6 weeks, 6 months, 1 year
measure: Korean Forgiveness Scale-Short Form
timeFrame: baseline, 6 weeks, 6 months, 1 year
measure: Korea Version of Alcohol Use Disorder Identification Test
timeFrame: baseline
measure: Korean Smartphone Addiction Proneness Scale for Adults
timeFrame: baseline
measure: Korean version of Nicotine Dependence Syndrome Scale
timeFrame: baseline
measure: Eysenck Personality Inventory
timeFrame: baseline
measure: Urine Cotinine Test
timeFrame: baseline
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
Study officials:
References: