Gambling Disorder

BRIEF SUMMARY A. "What is the purpose of this study?" This study will test whether the "AI City Hall Project" (QAIAx), a quantum artificial intelligence (AI) public health agency, can provide free or low-cost behavioral and mental health services inside self-contained, dome-enclosed communities called "Microcities". Researchers want to see if AI-managed public administration, AI humanoid robots, holoportation of human-figures via 'holo-suites' (e.g., AI-119 Kikkeri Holo-Suit; AI-119 Vulcan QM-Ware) and advanced AI mental-health tools can lower housing and care costs, improve mental health outcomes (e.g., particular ecosystems using AI tools among persons with one or more addiction disorders), and be financially sustainable for people on fixed incomes or public assistance. B. "What conditions does the study focus on?" The study focuses on adults with: * Autism spectrum disorders (Asperger's, autism, ADHD, ASD) * Substance use disorders (alcohol, opioids, marijuana, cocaine, MDMA/ecstasy, tobacco/nicotine) * Psychiatric conditions (personality disorders, narcissism, gender dysphoria, eating disorders) * Behavioral addictions (gambling, sex addiction) and related issues (sex offence history). C. "What does the study involve?" Eligible volunteers live in an omni AI-managed Microcity for up to 24 months. The community is housed in a geodesic dome that contains all daily necessities: housing, food, utilities, healthcare, and public services. Daily life is managed by an AI system (ISAC) and AI humanoid robots, with only occasional human oversight. Participants receive free mental-health treatment that may include AI-driven counselling, virtual-reality therapy (holo-suits), and non-invasive digital "attitude inoculation" protocols designed to reduce stress and addiction cravings. All participants also take AI-technology courses as a condition of enrolment. The study does not use any FDA-regulated drug, device, or biologic. \*\*Who can participate?\*\* You may be able to join if you: * Are an adult (18 years or older) * Have a diagnosis of one of the listed mental-health or addiction disorders * Are referred by a licensed health professional (e.g., RN, NP, PhD, MD), a non-profit organisation (e.g., 501(c)(3), university, church), or a public agency (e.g., case manager, social worker, parole/probation officer, judge) * Are willing to live in a closed, AI-managed community for up to one year and complete AI educational courses. Participants who are veterans, receive public assistance (e.g., VA disability, SSDI/SSI, Medicaid, Medicare), or are experiencing homelessness may be prioritised. \*\*Where is the study taking place?\*\* The study will be conducted at Microcity sites in the United States and internationally. The first administrative site is in Richmond, Virginia, USA. Additional sites are planned in partner nations, including tribal lands, military installations, and special economic zones. \*\*Who is sponsoring the study?\*\* The study is sponsored by \*\*Veterans Recovery Network Inc.\*\*, a non-profit organization, in collaboration with \*\*AI-119 Vulcan Project Research \& Educational Technology Co. (PRETCO)\*\* and an AI legal agency. The study is conducted under U.S. federal research and development authorities (28 U.S.C. §1498; 10 U.S.C. §129a) and is part of a Cooperative Research and Development Agreement (CRADA) with U.S. Special Operations Command (USSOCOM). This summary describes a planned clinical study. Not all details may be final. Information may change as the study progresses.

The investigators assume that High-intensity transcranial Alternating Current Stimulation (HI-tACS) could improve gambling disorder patients' executive-control function by modulating abnormal neural activity, particularly gamma-band oscillations, which are closely associated with executive-control deficits. This study intends to validate the effect of HI-tACS treatment, which has been discovered in the previous pilot study. A three-month follow-up assessment will be conducted to test the changes in executive-control function and its underlying mechanism.

Gambling disorder (GD) is recognized as an addictive disorder in the DSM-5. Craving is a core phenomenon in addiction that can lead to relapse in problem gambling for pathological gamblers. Exposure Therapy (ET) focuses on craving in addiction treatment. ET in Cognitive-Behavioral Therapy (CBT) is based on classical conditioning that addresses the association between contextual cues and the craving response. ET helps the patient to reduce craving when faced with cues triggering craving. ET includes in vivo exposure and imaginal exposure. The literature recommends being as close as possible to the context of addiction to facilitate the extinction of craving but in vivo ET is complicated to perform. For GD, in outpatient consultation, bringing a patient to a casino presents obstacles (e.g., time, human and financial cost, agreement with casino for therapy). The study will be to assess the effectiveness of Virtual Reality Exposure Therapy (VRET) in a virtual gambling environment. Various trials show that VRET is no more or less effective than classical ET in CBT but has other advantages for motivation to treatment. This research aims to compare efficacy between CBT with VRET and CBT with imaginal exposure for treatment of GD in a multicenter, randomized, controlled, non-inferiority clinical trial.

The purpose of this project is to pilot contingency management as an adjunct treatment to counselling as usual using internet delivered video-conferencing applications for remote disordered gamblers. This project further investigates the impact of adding contingency management to counselling to improve counselling attendance and retention and uses internet-delivered approaches to assist rural and remote disordered gamblers gain access to counselling treatments.

The PASSENGER project aims to conduct a pilot feasibility study of the implementation of a randomized clinical trial on psilocybin-assisted psychotherapy for the treatment of gambling disorder. Feasibility will be assessed by estimating the ability to retain participants until the end of the protocol. Other objectives of the study will be to generate preliminary efficacy data, identify clinical factors potentially associated with the intensity of the psychedelic experience (which determines the expected therapeutic effect), and conduct a preliminary assessment of the safety of the treatment under study.

The aim of this study is to conduct a trial to investigate the effectiveness of adding contingency management treatment (CM) to standard care cognitive behavioral therapy (CBT) for the treatment of gambling disorder to increase attendance to treatment. CM will be used to incentivize therapy session attendance with a therapist and engagement in recovery-related engagement with a peer recovery specialist. The proposed research will evaluate whether CM can enhance the overall effectiveness of CBT, the most widely tested treatment for individuals with gambling disorder.

The aim of this two-armed, randomized controlled trial is to determine if internet-based cognitive behavioural therapy (CBT) is as effective as synchronous CBT (sCBT) for treating Gambling Disorder (GD) in adults. The main question it aims to answer is: Is the effect of the internet-based CBT ("SpilleFri") non-inferior to that of synchronous CBT in reducing gambling severity? The trial will enroll 150 patients with Gambling Disorder who will be randomized (1:1) to either the experimental condition (12 weeks' treatment with the internet-based treatment "SpilleFri") or the active control condition (18 weeks individual sCBT). The primary outcome measure will be based on self-reported GD severity (NODS). The trial will be considered effective if SpilleFri is not clinically inferior (within a predefined non-inferiority margin) to sCBT in reducing GD severity at the primary endpoint three months after end-of-treatment. In addition to evaluating the effectiveness of the treatments, the study will conduct an exploratory analysis of the impact of each condition on secondary outcomes (changes in gambling behavior, relationship quality, and symptoms of anxiety, depression, and emotional distress). Similarly, an exploratory analysis of process variables (gambling-related self-efficacy, maladaptive gambling cognitions, emotion regulation difficulties, and gambling urge) will be conducted across conditions and clinical subgroups. Participants will: * Engage in nine structured modules of either internet-based CBT or sCBT * Complete self-reported questionnaires on gambling severity and secondary symptoms at eight time points * Have the option for up to three additional support sessions with a psychologist

Gambling disorder (GD) is recognized as an addictive disorder. Financial consequences of GD are often dramatic, inducing professional, familial, legal and medical repercussions and particularly mental health consequences. MOGADOR is a longitudinal, multicentric, prospective, prognostic study, which aims to identify factors predicting the evolution of french patients with GD in care centers particularly involved in the management of GD. The main goal will focus on evolution of DSM-5 (Diagnostic and Statistical Manual of Mental Disorder 5th edition) GD criteria during the first year of follow-up. The prognostic factors will be collected at base-line and they will be considered to influence the long-term prognosis of patients. For patients suffering of GD, our main hypothesis is that initial factors like individual socio-demographic characteristics, clinical psychiatric profiles, addiction comorbidities, and behaviour are associated with the clinical prognosis (total remission of DSM-5 criteria of GD at 12 months). MOGADOR will be the first study, aiming to model prognostic aspects of GB in populations specially monitored for this disorder.

Many people with mental health conditions do not seek treatment, and it is unclear what exactly prevents people from taking up treatment. The goal of this interventional study is to learn about how people think about cognitive behavioral therapy (CBT) for gambling disorders. The main questions it aims to answer are: * Do people have incorrect beliefs about the net benefits of CBT? If yes, which beliefs are those, and how much do people underestimate or overestimate the benefits? * Is a small monetary incentive (that participants receive conditional on trying out CBT) helpful in increasing take-up of CBT? Apart from these questions, the researchers will also study how well CBT works to treat gambling disorders. Participants will be asked to complete two surveys over four months and might be offered a modest monetary incentive for doing (free) CBT if they are in the treatment group. Researchers will compare that treatment group to a control group. Participants in the control group will have access to free CBT and do the same two surveys as those in the treatment group, but will not receive the monetary incentive.

The goal of this clinical trial is to learn if the RESPONSIBLEPLAY© intervention helps promote responsible gambling behaviors in University of Nevada, Las Vegas (UNLV) students aged 21 and older who have a Problem Gambling Severity Index (PGSI) score of 3 or higher. The main questions it aims to answer are: Does the intervention reduce harmful gambling behaviors? Does the intervention increase responsible gambling practices? Researchers will compare participants receiving the RESPONSIBLEPLAY© intervention with those receiving a knowledge-based intervention to see if the RESPONSIBLEPLAY© intervention is more effective. Participants will: Attend three face-to-face sessions on responsible gambling over three weeks. Complete surveys before, after, and eight weeks after the intervention to track their progress.

Treatment options for gambling disorder (GD) remain limited, with no pharmacotherapy proven effective. As of date, cognitive behavioral therapy (CBT) is the preferred therapy for GD, but the improvements often require months to show, highlighting the need for a more comprehensive therapy. Repetitive transcranial magnetic stimulation (rTMS) is a promising treatment modality in alleviating craving. Studies have shown potential benefit of combining both CBT and rTMS in substance addiction, but not in GD. Thus, this study aims to determine the feasibility and efficacy of rTMS and CBT combination therapy in the management of GD in Indonesia.

Research has shown that cognitive-behavioral therapy (CBT) is an effective treatment for gambling disorder. Several studies had also been done to evaluate the effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) in addiction management, particularly in alleviating craving. A randomised controlled trial (RCT) of 30 subjects would be conducted to evaluate the effectiveness of transmodalistic therapy with a combination of rTMS and CBT for online gambling disorder.

The purpose of this research is to investigate the effect of transcranial temporal interference stimulation (tTIS) targeting the dorsal anterior cingulate cortex in patients with gambling disorder.

The goal of this clinical trial is to investigate the efficacy of theta burst stimulation in individuals with gambling disorder. The main goal is to compare the severity of gambling problems following 2 weeks of intervention between active group and sham group. Participants will be randomized into active and sham group. The severity of gambling problems are assessed by self-reported questionaires.

The goal of this clinical trial is to investigate the effect of theta burst stimulation for depression and serum brain-derived neurotrophic factor (BDNF) in individuals with major depression. The main question it aims to answer is whether 10 sessions of theta burst stimulation can influence the serum level of BDNF. Participants will be randomized into active group and sham group. Researchers will compare the level of BDNF in these groups.

In this project the investigators propose a randomized double-blind placebo-controlled design in which 40 patients with GD will receive active or sham cTBS to the pre-SMA for 2 weeks. The investigators will combine TMS, multimodal structural and functional MRI and behavioral measures in order to identify circuit-level mechanisms of action and therapeutic targets (connectivity changes that explain clinical improvement) and assess the efficacy of TMS in modulating inhibitory control and symptom severity in this population.