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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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
  • Naruse Mental Clinic

    Machida, Tokyo, 1940045

    Taku Sato, +81-42-710-7657, ta56_sato@yahoo.co.jp

    Recruiting

Other trials in Japan

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:

  1. 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;
  2. 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;
  3. 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) ;
  4. 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.

  1. 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.
  2. 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.
  3. 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;

  1. Identify original desires, which have been covered by intensive craving for gambling.
  2. Aim to satisfy only a single desire if you hope to continue gambling.
  3. 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.

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 groups in NCT02491996
Study groupRoleWhat they receive
DTIGExperimentalOutpatients 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.

  1. 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.

  1. First posted8 Jul 2015 (estimated)
  2. Study startJun 2013
  3. Primary completionMar 2016 (estimated)
  4. Study completionMar 2018 (estimated)

Resources

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)
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

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.

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