The Effect of Self Stigma Tailored Cognitive Behavioral Therapy on Gambling Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in Self-Stigmatization Score as Measured by the Self-Stigma Scale (SSS). Baseline (Week 0) to Post-treatment (Week 4) and Follow-up (Week 8)
研究概览
简要总结
The goal of this clinical trial was to evaluate whether a cognitive behavioral therapy (CBT) program focused on self-stigma could help reduce both self-stigma and gambling disorder severity in adults diagnosed with gambling disorder.
The main questions it aimed to answer were:
Did self-stigma-focused CBT lower self-stigmatizing thoughts in individuals with gambling disorder? Did the severity of gambling disorder symptoms decrease after the intervention? Did these changes remain stable after the treatment ended? Did self-stigma play a role in how the treatment worked? Participants were assigned to either an intervention group or a control group. Completed assessments before the treatment, after the treatment, and during the 1 month follow-up period.
Participants in the intervention group:
Received four sessions of cognitive behavioral therapy (face-to-face or online) targeting self-stigmatizing thoughts related to gambling Researchers compared the intervention and control groups to observe whether self-stigmatization affected treatment outcomes. Surveys used in this study included a self-stigma scale and the South Oaks Gambling Screen (SOGS).
A total of 26 participants (13 in each group) were enrolled in the study; in addition, 3 extra participants per group were included to account for possible dropouts.
The results were analyzed using statistical methods.
详细描述
The total duration of the study is 13 months, from March 2024 to April 2025. The stages of the study were planned according to weeks (W). The timeline and phases of the study are as follows:
- Sample screening - March 2024, W1-W4
- Assessment session and pre-test measurements (March 2024, W2-W4)
- Randomization and assignment of research groups (April 2024, W5-W6)
- Informing the participants (April 2024, W5-W6)
- Intervention (psychotherapy sessions) (April 2024 - September 2024, W7-W20)
- Post-test measurements (September 2024 - October 2024, W21-W23)
- Follow-up measurements (December 2024 - January 2025, W27-W29)
- Data analysis (January 2025, W30-W32)
- Reporting (February 2025 - April 2025, W33-W39)
- Sample Screening Face-to-face or telephone interviews were conducted with patients who applied to the Addiction Unit of the Institute on Drug Abuse, Toxicology and Pharmaceutical Sciences at Ege University. For patients diagnosed with Gambling Disorder at the outpatient clinic, appointments were scheduled for face-to-face assessments. Preliminary interviews and appointment scheduling continued until a sufficient number of participants were reached.
- Assessment Session and Pre-Test Measurements
The steps of the assessment session (clinical evaluation) are as follows:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting the diagnostic criteria for Gambling Disorder (GD) according to the DSM-5:
- •Currently receiving or having completed the standard treatment provided at the outpatient clinic.
- •Scoring 72 or above on the Self Stigma Scale.
- •Being between 18 and 65 years old.
排除标准
- •"Intellectual Disability" classified under neurodevelopmental disorders.
- •"Communication Disorders" resulting from neurodevelopmental disorders or another medical condition.
- •Based on clinical interviews and DSM-5 diagnostic criteria:
- •"Bipolar and Related Disorders" with psychotic features.
- •"Depressive Disorders" with psychotic features.
- •"Dissociative Disorders" such as depersonalization, derealization, or identity disruption.
- •Any disorder classified under "Schizophrenia Spectrum and Other Psychotic Disorders," including schizophrenia, schizotypal personality disorder, and schizoaffective disorder.
研究组 & 干预措施
Experimental (Intervention) Group
Participants in the research arm received "Self Stigma Tailored Cognitive Behavioral Therapy on Gambling Disorder" addition to the standard treatment for Gambling Disorder (GD) provided at the Addiction Clinic.
The standard treatment includes the medical treatment for GD and motivational interviews administered by a psychiatrist at the Addiction Clinic where the research is conducted.
干预措施: Self Stigma Tailored Cognitive Behavioral Therapy on Gambling Disorder (Behavioral)
Experimental (Intervention) Group
Participants in the research arm received "Self Stigma Tailored Cognitive Behavioral Therapy on Gambling Disorder" addition to the standard treatment for Gambling Disorder (GD) provided at the Addiction Clinic.
The standard treatment includes the medical treatment for GD and motivational interviews administered by a psychiatrist at the Addiction Clinic where the research is conducted.
干预措施: standart pharmacotherapy (Drug)
Experimental (Intervention) Group
Participants in the research arm received "Self Stigma Tailored Cognitive Behavioral Therapy on Gambling Disorder" addition to the standard treatment for Gambling Disorder (GD) provided at the Addiction Clinic.
The standard treatment includes the medical treatment for GD and motivational interviews administered by a psychiatrist at the Addiction Clinic where the research is conducted.
干预措施: motivational intervention (Behavioral)
Control Group
Participants in the control group received the standard treatment for Gambling Disorder (GD), as described in the previous paragraph, at the Institute's Addiction Clinic. The duration and type of treatment were tailored to the individual patient by the psychiatrist. During the period when the experimental group received the Self Stigma Tailored Cognitive Behavioral Therapy for Gambling Disorder, the control group participants were placed on the waiting list and did not receive any specific intervention for self-stigma perception.
干预措施: standart pharmacotherapy (Drug)
Control Group
Participants in the control group received the standard treatment for Gambling Disorder (GD), as described in the previous paragraph, at the Institute's Addiction Clinic. The duration and type of treatment were tailored to the individual patient by the psychiatrist. During the period when the experimental group received the Self Stigma Tailored Cognitive Behavioral Therapy for Gambling Disorder, the control group participants were placed on the waiting list and did not receive any specific intervention for self-stigma perception.
干预措施: motivational intervention (Behavioral)
结局指标
主要结局
Change in Self-Stigmatization Score as Measured by the Self-Stigma Scale (SSS). Baseline (Week 0) to Post-treatment (Week 4) and Follow-up (Week 8)
时间窗: post-treatment (Week 4) and follow-up (Week 8)
Self-stigma will be measured using the Self-Stigma Scale (SSS). Scores range from 36 to 144, with 72 and higher scores indicating severe self-stigmatization. Changes from baseline (Week0) to post-treatment (Week 4) and follow-up (Week 8) will be analyzed.
Change in Gambling Severity Score as Measured by the South Oaks Gambling Screen (SOGS). Baseline (Week 0) to Post-treatment (Week 4) and Follow-up (Week 8)
时间窗: post-treatment (Week 4) and follow-up (Week 8)
Gambling severity will be assessed using the South Oaks Gambling Screen (SOGS). Scores range from 0 to 19, with higher scores indicating greater gambling-related problems. Changes from baseline to post-treatment and follow-up will be analyzed.
次要结局
未报告次要终点
研究者
Ayça Çınaroğlu Asar
Principal Investigator
Ege University