Pathological GamblingETFDDGNCT02491996
The Efficacy of Therapy Focused on Desire-satisfaction for Disordered Gamblers
A study testing desire satisfaction-targeted intervention for disordered gamblers in people with Pathological Gambling, run by Kurihama Medical and Addiction Center at 1 site in Japan.
Trial summary
The investigators proposed a desire satisfaction-targeted intervention for disordered gamblers (DTIG) due to the limitations of the abstinence-targeted intervention, which is based on the weak self-control relative to growing desire to gamble. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pathological Gambling
- What is being tested?
- desire satisfaction-targeted intervention for disordered gamblers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2013to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects were outpatients who are treated by DTIG at Outpatient Unit for Gambling Disorder of Kurihama Medical and Addiction Center in Japan. This intervention consists of an initial psychiatric assessment, followed by psychoeducational approach based on desire satisfaction-targeted intervention by psychiatrists, and three group sessions based on CBT by psychologists. Patients with psychiatric comorbidities are treated with the appropriate pharmacological regimens.
- All were over 20 years of age and met Diagnostic and Statistical Manual of Mental Disorders 5thed. (DSM-5) criteria for a diagnosis of gambling disorder.
Who cannot join
- We exclude patients with acute psychotic symptoms including manic symptoms or cognitive impairment that could compromise their ability to complete the research questionnaires.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Naruse Mental Clinic
Machida, Tokyo, 1940045
Taku Sato, +81-42-710-7657, ta56_sato@yahoo.co.jp
About this study
Official title: The Efficacy of Cognitive-behavioral Therapy Focused on Desire-satisfaction for Treatment-seeking Disordered Gamblers
The investigators proposed a desire satisfaction-targeted intervention for disordered gamblers (DTIG) due to the limitations of the abstinence-targeted intervention, which is based on the weak self-control relative to growing desire to gamble. This intervention model perceives loss of gambling control as a failure of strategy in which gambling is anticipated to fulfill various desires (i.e., desires for fame, money, and escapism). Therefore, the alternative behaviors to fulfill original desires directly become the main therapeutic purpose.
Materials and Methods: Outpatients who were primarily diagnosed as gambling disorder by the DSM-V were treated by DTIG. This method usually comprised 1 or 2 sessions, 60 minutes in duration, delivered by a psychiatrist. Participants were examined : 1) Basic background such as gender, age,; 2) medical variables such as the onset age, the duration of the problem gambling, psychiatric complications, motivation to quit gambling; 3) assessment of severity (DSM-5, SOGS and G-SAS); 4) Short prognosis; 6 months-outcome after intervention (problem gambling/ control gambling/ abstinence).
Read the detailed description
Introduction
Gambling disorder is a public health problem characterized by persistent and recurrent maladaptive patterns of gambling. A prevalence rate was 0.4-2.0% worldwide. In Japan, gambling is common: the prevalence rate of disordered gamblers is estimated to be 5.5% of adults.Gambling disorder resulted in clinical and subclinical harms, which are depression, suicidal behaviors, legal involvement, occupational/ educational disruptions, financial and interpersonal difficulties.
Some psychological treatment studies indicate a benefit of active treatments compared to no treatment or wait-list control conditions. On the other hand, the accumulated evidence seems to suggest that interventions based on the CBT produce the most favorable outcomes.Nevertheless CBT is not yet recognized as a standard treatment for gambling disorder. What is the therapeutic insufficiency in CBT for gambling disorder? The fundamental aim of CBT, especially cognitive therapy for gambling disorder is to identify and correct irrational and unrealistic beliefs postulated to contribute to excessive gambling, which is usually the control over the outcome regardless of the randomness. However, although majority of disordered gamblers already understand that this belief is theoretically irrational, they cannot quit problem gambling. For recovery they may need not only cognitive changes in illusions of control but also motivated inner power such as desires.
Therefore the investigators assumed that disordered gamblers could not quit or control gambling because their original desires which had constructed pathological craving for gambling had not been satisfied. Namely most important erroneous beliefs for which the investigators should target in CBT are ones concerning not the nature of gambling itself but original desires. The investigators thought this hypothesis focused on original desire with reference to the studies of natural recovery process.
In this study, in order to reveal the efficiency of this intervention more clearly, for disordered gamblers the investigators compared a six months-outcome between this intervention, which we named a "desire satisfaction-targeted intervention for gambling disorder" (DTIG), and an ordinary abstinence-targeted intervention.
Methods:
Participants Subjects are outpatients who are treated by DTIG at Outpatient Unit for Gambling Disorder of Kurihama Medical and Addiction Center in Japan. This intervention consists of an initial psychiatric assessment, followed by psychoeducational approach based on desire satisfaction-targeted intervention by psychiatrists, and three group sessions based on CBT by psychologists. Patients with psychiatric comorbidities are treated with the appropriate pharmacological regimens.
All are over 20 years of age and meet Diagnostic and Statistical Manual of Mental Disorders 5thed. (DSM-5) criteria for a diagnosis of gambling disorder. 2) The investigators exclude patients with acute psychotic symptoms including manic symptoms or cognitive impairment that can compromise their ability to complete the research questionnaires.
This investigation is carried out in accordance with the Declaration of Helsinki, and going to be approved by the ethical committee of Kurihama Medical and Addiction Center. All subjects should be provided written informed consent.
Procedure
Participants are examined as follows at the first hospital visit:
- Basic and medical background such as gender, age, married or not, educated beyond twelve years or not, employed or not, addiction-related family history (defined as a second-degree or closer family member with an addictive disorder), crime history, suicide history, current psychiatric complications;
- Gambling-related variables such as the age of gambling onset, the age of problem-gambling onset, time lag between gambling onset and the onset of problematic gambling (time lag), the duration of the problem gambling, predominant gambling activity (non-strategic or not), total amount of debt, method of debt management (bankruptcy or not), Attendance at Self Help Group, motivation to quit gambling;
- Assessment of severity such as the number of items in DSM-5, scores of South Oaks Gambling Screen (SOGS) 23) and the Gambling Symptom Assessment Scale (G-SAS) 15) ;
- Outcome concerning gambling behavior in 3 and 6 months after DTIG.
Assessment of Severity Severity of gambling disorder is measured using the above three reliable and valid instruments.
- DSM-5: The standard of severity is defined in the DSM-5 based on the number of items that are met: 4-5 is mild, 6-7 is moderate, and 8-9 is severe.
- SOGS: 20-item self-report questionnaire providing a cut-off score for pathological gambling using DSM criteria. The accepted cut-off point for problem gambling is 5, with higher scores denoting more severe gambling problems.
- G-SAS: 12-item self-report scale examining gambling urges, thoughts, and behaviors during the previous week.
Assessment of Outcome The investigators ask participants two questions concerning gambling behaviors 3 months and 6 months after intervention by mail or telephone, which are "Did participants gamble during this period (three or six months)?" and "Did some troubles with gambling happen during this three months if participants gambled?" The outcome is distinguished on a 3-stepped degree through the above two questionnaires; (keeping abstinence continuously / continuing gambling, but no problem during this three months / keeping problem gambling continuously). In this study, problem gambling was defined as "gambling accompanied by monetary, occupational/educational, familial and legal problem such as debts, absence, marital crisis and embezzlement etc."
Desire satisfaction-targeted intervention for gambling disorder (DTIG) The investigators have performed DTIG instead of ordinary abstinence-targeted intervention. In this intervention, whether patients currently gamble or not is once shelved. This intervention consists of three steps;
- Identify original desires, which have been covered by intensive craving for gambling.
- Aim to satisfy only a single desire if you hope to continue gambling.
- Search and try alternative behaviors which directly satisfy the original desires.
One or two psycho-educational sessions based on above three steps were performed by psychiatrists (one session usually needs 30-60 minutes). A worksheet is utilized to progress this intervention smoothly.
Additionally three psycho-educational sessions are performed by psychologists to help to discover owns' desires (one session usually needs 60 minutes). These themes are "the total amounts of lost money", "advantage and disadvantage in gambling" and "alternative behaviors instead of gambling".
Statistical analysis Data entry and statistical analysis were performed using Microsoft ExcelⓇ 2010. A Pearson correlation analysis was used to assess correlations between outcome (abstinence / controlled gambling / problem gambling) and other variables in DTIG group. To identify the independent predictors of outcome, multiple stepwise backward linear regression analysis was used and an analysis of variance for the full regression models was performed.
These analyses were repeated using all participants (intention-to-treat analysis: ITT). Therefore cases that dropped out of the following system were set as cases that continued problem gambling (worst cases analysis). Statistical significance was set at p < 0.05.
- Conditions
- Pathological Gambling
- Being tested
- desire satisfaction-targeted intervention for disordered gamblers
- Keywords
- desire model
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desire satisfaction-targeted intervention for disordered gamblersBehavioural
This intervention consists of an initial psychiatric assessment, followed by psychoeducational approach based on desire satisfaction-targeted intervention by psychiatrists, and three group sessions based on CBT by psychologists. Patients with psychiatric comorbidities are treated with the appropriate pharmacological regimens.
| Study group | Role | What they receive |
|---|---|---|
| DTIG | Experimental | Outpatients who treated by DTIG at Outpatient Unit for Gambling Disorder of Kurihama Medical and Addiction Center Receives: Behavioral: desire satisfaction-targeted intervention for disordered gamblers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of gambling
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startJun 2013
- Primary completionMar 2016 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathological GamblingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kurihama Medical and Addiction Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasunobu Komoto, Kurihama Medical and Addiction Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491996
- Sponsor's protocol ID
- 223
- Acronym
- ETFDDG
- Status last verified
- Jul 2015
- First submitted
- 27 Feb 2015
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Cognitive-behavioral Therapy Focused on Desire-satisfaction for Treatment-seeking Disordered Gamblers
- ClinicalTrials.gov ID
- NCT02491996
- Acronym / sponsor ID
- ETFDDG / 223
- Conditions
- Pathological Gambling
- Keywords
- desire model
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kurihama Medical and Addiction CenterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 8 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators proposed a desire satisfaction-targeted intervention for disordered gamblers (DTIG) due to the limitations of the abstinence-targeted intervention, which is based on the weak self-control relative to growing desire to gamble. This intervention model perceives loss of gambling control as a failure of strategy in which gambling is anticipated to fulfill various desires (i.e., desires for fame, money, and escapism). Therefore, the alternative behaviors to fulfill original desires directly become the main therapeutic purpose.
Materials and Methods: Outpatients who were primarily diagnosed as gambling disorder by the DSM-V were treated by DTIG. This method usually comprised 1 or 2 sessions, 60 minutes in duration, delivered by a psychiatrist. Participants were examined : 1) Basic background such as gender, age,; 2) medical variables such as the onset age, the duration of the problem gambling, psychiatric complications, motivation to quit gambling; 3) assessment of severity (DSM-5, SOGS and G-SAS); 4) Short prognosis; 6 months-outcome after intervention (problem gambling/ control gambling/ abstinence).
Detailed description
Introduction
Gambling disorder is a public health problem characterized by persistent and recurrent maladaptive patterns of gambling. A prevalence rate was 0.4-2.0% worldwide. In Japan, gambling is common: the prevalence rate of disordered gamblers is estimated to be 5.5% of adults.Gambling disorder resulted in clinical and subclinical harms, which are depression, suicidal behaviors, legal involvement, occupational/ educational disruptions, financial and interpersonal difficulties.
Some psychological treatment studies indicate a benefit of active treatments compared to no treatment or wait-list control conditions. On the other hand, the accumulated evidence seems to suggest that interventions based on the CBT produce the most favorable outcomes.Nevertheless CBT is not yet recognized as a standard treatment for gambling disorder. What is the therapeutic insufficiency in CBT for gambling disorder? The fundamental aim of CBT, especially cognitive therapy for gambling disorder is to identify and correct irrational and unrealistic beliefs postulated to contribute to excessive gambling, which is usually the control over the outcome regardless of the randomness. However, although majority of disordered gamblers already understand that this belief is theoretically irrational, they cannot quit problem gambling. For recovery they may need not only cognitive changes in illusions of control but also motivated inner power such as desires.
Therefore the investigators assumed that disordered gamblers could not quit or control gambling because their original desires which had constructed pathological craving for gambling had not been satisfied. Namely most important erroneous beliefs for which the investigators should target in CBT are ones concerning not the nature of gambling itself but original desires. The investigators thought this hypothesis focused on original desire with reference to the studies of natural recovery process.
In this study, in order to reveal the efficiency of this intervention more clearly, for disordered gamblers the investigators compared a six months-outcome between this intervention, which we named a "desire satisfaction-targeted intervention for gambling disorder" (DTIG), and an ordinary abstinence-targeted intervention.
Methods:
Participants Subjects are outpatients who are treated by DTIG at Outpatient Unit for Gambling Disorder of Kurihama Medical and Addiction Center in Japan. This intervention consists of an initial psychiatric assessment, followed by psychoeducational approach based on desire satisfaction-targeted intervention by psychiatrists, and three group sessions based on CBT by psychologists. Patients with psychiatric comorbidities are treated with the appropriate pharmacological regimens.
All are over 20 years of age and meet Diagnostic and Statistical Manual of Mental Disorders 5thed. (DSM-5) criteria for a diagnosis of gambling disorder. 2) The investigators exclude patients with acute psychotic symptoms including manic symptoms or cognitive impairment that can compromise their ability to complete the research questionnaires.
This investigation is carried out in accordance with the Declaration of Helsinki, and going to be approved by the ethical committee of Kurihama Medical and Addiction Center. All subjects should be provided written informed consent.
Procedure
Participants are examined as follows at the first hospital visit:
- Basic and medical background such as gender, age, married or not, educated beyond twelve years or not, employed or not, addiction-related family history (defined as a second-degree or closer family member with an addictive disorder), crime history, suicide history, current psychiatric complications;
- Gambling-related variables such as the age of gambling onset, the age of problem-gambling onset, time lag between gambling onset and the onset of problematic gambling (time lag), the duration of the problem gambling, predominant gambling activity (non-strategic or not), total amount of debt, method of debt management (bankruptcy or not), Attendance at Self Help Group, motivation to quit gambling;
- Assessment of severity such as the number of items in DSM-5, scores of South Oaks Gambling Screen (SOGS) 23) and the Gambling Symptom Assessment Scale (G-SAS) 15) ;
- Outcome concerning gambling behavior in 3 and 6 months after DTIG.
Assessment of Severity Severity of gambling disorder is measured using the above three reliable and valid instruments.
- DSM-5: The standard of severity is defined in the DSM-5 based on the number of items that are met: 4-5 is mild, 6-7 is moderate, and 8-9 is severe.
- SOGS: 20-item self-report questionnaire providing a cut-off score for pathological gambling using DSM criteria. The accepted cut-off point for problem gambling is 5, with higher scores denoting more severe gambling problems.
- G-SAS: 12-item self-report scale examining gambling urges, thoughts, and behaviors during the previous week.
Assessment of Outcome The investigators ask participants two questions concerning gambling behaviors 3 months and 6 months after intervention by mail or telephone, which are "Did participants gamble during this period (three or six months)?" and "Did some troubles with gambling happen during this three months if participants gambled?" The outcome is distinguished on a 3-stepped degree through the above two questionnaires; (keeping abstinence continuously / continuing gambling, but no problem during this three months / keeping problem gambling continuously). In this study, problem gambling was defined as "gambling accompanied by monetary, occupational/educational, familial and legal problem such as debts, absence, marital crisis and embezzlement etc."
Desire satisfaction-targeted intervention for gambling disorder (DTIG) The investigators have performed DTIG instead of ordinary abstinence-targeted intervention. In this intervention, whether patients currently gamble or not is once shelved. This intervention consists of three steps;
- Identify original desires, which have been covered by intensive craving for gambling.
- Aim to satisfy only a single desire if you hope to continue gambling.
- Search and try alternative behaviors which directly satisfy the original desires.
One or two psycho-educational sessions based on above three steps were performed by psychiatrists (one session usually needs 30-60 minutes). A worksheet is utilized to progress this intervention smoothly.
Additionally three psycho-educational sessions are performed by psychologists to help to discover owns' desires (one session usually needs 60 minutes). These themes are "the total amounts of lost money", "advantage and disadvantage in gambling" and "alternative behaviors instead of gambling".
Statistical analysis Data entry and statistical analysis were performed using Microsoft ExcelⓇ 2010. A Pearson correlation analysis was used to assess correlations between outcome (abstinence / controlled gambling / problem gambling) and other variables in DTIG group. To identify the independent predictors of outcome, multiple stepwise backward linear regression analysis was used and an analysis of variance for the full regression models was performed.
These analyses were repeated using all participants (intention-to-treat analysis: ITT). Therefore cases that dropped out of the following system were set as cases that continued problem gambling (worst cases analysis). Statistical significance was set at p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DTIG | Experimental | Behavioral: desire satisfaction-targeted intervention for disordered gamblersOutpatients who treated by DTIG at Outpatient Unit for Gambling Disorder of Kurihama Medical and Addiction Center |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects were outpatients who are treated by DTIG at Outpatient Unit for Gambling Disorder of Kurihama Medical and Addiction Center in Japan. This intervention consists of an initial psychiatric assessment, followed by psychoeducational approach based on desire satisfaction-targeted intervention by psychiatrists, and three group sessions based on CBT by psychologists. Patients with psychiatric comorbidities are treated with the appropriate pharmacological regimens.
- All were over 20 years of age and met Diagnostic and Statistical Manual of Mental Disorders 5thed. (DSM-5) criteria for a diagnosis of gambling disorder.
Key exclusion criteria (1 listed)
- We exclude patients with acute psychotic symptoms including manic symptoms or cognitive impairment that could compromise their ability to complete the research questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| desire satisfaction-targeted intervention for disordered gamblersThis intervention consists of an initial psychiatric assessment, followed by psychoeducational approach based on desire satisfaction-targeted intervention by psychiatrists, and three group sessions based on CBT by psychologists. Patients with psychiatric comorbidities are treated with the appropriate pharmacological regimens. | Behavioural | DTIG |
Primary outcome
Severity of gambling
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2015.
Related trials for Pathological Gambling
Not yet recruiting
Low-Intensity Focused Ultrasound for Gambling Disorder
Gambling Disorder, Gambling Addiction
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingPhase 2
Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a Pilot Study
Gambling Disorder
Recruiting
Digital Cognitive Behavioral Therapy for Gambling Disorder
Gambling Disorder, Gambling
RecruitingObservational study
Is Craving a Central Criterion for Diagnosing a Behavioral Addiction?
Addictive Behaviors, Internet Addiction Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing desire satisfaction-targeted intervention for disordered gamblers in people with Pathological Gambling, run by Kurihama Medical and Addiction Center at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasunobu Komoto (+81-46-848-1550, y_koumoto@kurihama1.hosp.go.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of gambling (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2015.