Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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 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:
• Providing detailed information about the study to patients who participated in the assessment session.
Randomization and Research Groups Participants were stratified based on their Self-Stigma Scale scores using the SPSS program, and then randomly assigned to the intervention and control groups within each stratum. To prevent selection bias, the random assignment of participants to groups was performed by a different researcher.
Informing the Participants After group assignment, participants in the intervention group were contacted to schedule their first psychotherapy session. Participants in the control group were informed that they had been placed on a waitlist. Patients who were found to be ineligible for participation based on exclusion criteria were also contacted and informed that they would not be included in the study.
Intervention (Psychotherapy Sessions): Self-Stigma Tailored Cognitive Behavioral Therapy on Gambling Disorder (SSCBT-GD) The SSCBT-GD intervention will be conducted with participants in the intervention group according to a structured protocol, scheduled at mutually agreed dates and times. Each psychotherapy session will be conducted approximately one week apart. The duration of each session is 60 minutes. The intervention consists of a total of four sessions, unless otherwise interrupted (e.g., participant rescheduling a session).
Intervention Plan:
Session 1: Psychoeducation I • Addressing Gambling Disorder from a bio-psycho-social perspective.
Materials:
Operant learning model of Gambling Disorder, progressive model of stigma, progressive model of self-stigma, bio-psycho-social CBT model.
Session 2: Psychoeducation II
• Examining self-stigmatizing thoughts and their impact on behavior.
• Identifying automatic thoughts relevant to the individual's symptoms using cognitive techniques.
• Introducing cognitive awareness and the foundations of cognitive restructuring through evidence-based examination techniques.
Materials:
Emotion-thought-behavior connection, thought and emotion analysis, evidence vs. counter-evidence examples and practice, thought-emotion reevaluation.
Session 3: Psychoeducation III • Aligning behaviors with personal values.
• Addressing goals for cognitive restructuring and behavioral change.
• Enhancing self-awareness.
Materials:
Values model, summary reminder, vicious cycle diagram.
Session 4: Psychoeducation IV • Exploring the interaction between emotions, thoughts, and behaviors. • Increasing awareness of personal life patterns and experiences. • Discussing foresight and preventative strategies.
• Relapse prevention strategies and termination process.
Materials:
Integrated summary of addiction and self-stigma, example triggering thoughts, relapse prevention form.
Homework Assignments Homework is a technique commonly used in CBT interventions to reinforce therapeutic gains. Its goal is to support participants in internalizing the intervention content by engaging with the material between sessions. These assignments remain with the participant and serve as a summary of their therapeutic journey.
• Homework 1: Problem List - Aims to assess the participant's current awareness of the problem.
• Homework 2: A-B-C (Illustrated) - Helps recognize and label thoughts and emotions in specific situations.
• Homework 3: New Book, Old Book - Encourages the participant to explore emotions, thoughts, and alternative perspectives.
Participants who attended only one, two, or three psychotherapy sessions were not considered to have completed the intervention. Only those who participated in all four sessions were deemed to have completed it.
Treatment as Usual (TAU):
Throughout the SSCBT-GD intervention, all participants in both the experimental and control groups continued to receive TAU from the addiction outpatient clinic. The content and duration of TAU were determined individually by the clinic psychiatrist. TAU primarily consisted of medical treatment and motivational interviewing when necessary.
Post-Intervention and Follow-Up Assessments The Self-Stigma Scale and South Oaks Gambling Screen were used as measurement tools for both post-intervention and follow-up assessments. These assessments were conducted simultaneously for participants in both the experimental and control groups.
Post-intervention assessments (t1) were conducted four weeks after the start of the intervention (the date of the first psychotherapy session was considered the start date).
Follow-up assessments (t2) were conducted four weeks after the post-intervention assessments.
Data Analysis After the follow-up assessments were completed, the data collected through the measurement tools were analyzed. The experimental and control groups were compared in terms of the study's dependent variables.
Intervention for the Control Group If the analysis revealed that participants in the experimental group benefited from the SSCBT-GD intervention, the same intervention was offered to the control group for ethical reasons
Reporting The research process and findings were documented and presented in tabular format. The reporting phase constituted the final stage of the study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental (Intervention) Group | Experimental | 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. |
|
| Control Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self Stigma Tailored Cognitive Behavioral Therapy on Gambling Disorder | Behavioral | The Self Stigma Tailored Cognitive Behavioral Therapy for Gambling Disorder (SSCBT) is a novel intervention designed specifically for this study and has not been previously used or named in existing literature. This 4-session protocol can be integrated into any part of GD treatment. Each session was accompanied by materials specifically designed for that session's content, and assignments related to the session's topics were given at the end of each session. Session 1: Gambling Disorder from a bio-psycho-social perspective, stigma and self-stigma, CBT introduction, cognitive-behavioral model of self-stigmatization, impact of emotions and cognitive distortions. S. 2: Self-stigmatizing thoughts and behaviors, identifying automatic thoughts with cognitive techniques, cognitive awareness, and restructuring with evidence examination. S. 3: Aligning behaviors with values, cognitive restructuring, behavior change, and self-awareness. S. 4: Prevention strategies, relapse prevention planning. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | post-treatment (Week 4) and follow-up (Week 8) |
| 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) | 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. | post-treatment (Week 4) and follow-up (Week 8) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Umut Kırlı, Assoc. Prof. | Ege University, Addiction Clinic within the Institute of Addiction, Toxicology, and Pharmaceutical Sciences. | Study Director |
| Ayça Çınaroğlu Asar, B.A. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ege University | Izmir | Bornova | 3100 | Turkey (Türkiye) |
As the study has not yet been published, the plan to share individual participant data (IPD) is to be determined after the publication of the results.
Not provided
Not provided
Not provided
Not provided
Records of 66 patients were screened. Eleven did not meet criteria. Of the remaining 55, two lived outside the city, 13 could not be reached, and five declined. Thirty-five attended baseline assessment; nine were excluded due to low Self-Stigma scores. In total, 26 eligible participants were enrolled and randomized.
"Participants were recruited from the Addiction Unit of the Institute on Drug Abuse, Toxicology and Pharmaceutical Sciences at Ege University between March 2024 and April 2025. Recruitment involved face-to-face and telephone screening of patients diagnosed with Gambling Disorder during routine outpatient admissions. Screening continued until the required sample size was reached.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 20, 2025 |
Not provided
This study uses a randomized controlled trial design with an intervention and control group. Participants diagnosed with Gambling Disorder and followed at the Ege University Institute of Substance Addiction, Toxicology and Pharmaceutical Sciences were randomly assigned to the intervention or control group.The intervention group underwent a four-session structured cognitive behavioral therapy (CBT) program specifically designed to address self-stigma, while the control group received treatment as usual.Pre- and post-test assessments were conducted using the Self-Stigma Scale (SSS) and the South Oaks Gambling Screen (SOGS) to assess changes in self-stigma perception and gambling severity. Additionally, a follow-up assessment was conducted one month after post-testing to measure sustainability of improvements over time. A power analysis determined that 26 participants (13 per group) were required for a power of 0.80. To account for potential dropouts, the sample size was increased by 20%.
Not provided
Not provided
Not provided
Not provided
|
|
| standart pharmacotherapy | Drug | All participants continued to receive standard pharmacotherapy from their respective psychiatrists. |
|
| motivational intervention | Behavioral | All participants continued to receive the standard motivational interviewing intervention for addiction from their psychiatrist. |
|
| FG001 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
Baseline analyses included only participants who met the predefined eligibility criteria for the study: having a current diagnosis of Gambling Disorder and scoring 72 or above on the Self-Stigma Scale at baseline (T0). Participants who did not meet these criteria or had incomplete baseline assessments were excluded from the baseline analysis population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age (years) was recorded for each participant using the case report form at baseline. Each participant reported their own age at the time of enrollment. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Sex was recorded for each participant using the case report form at baseline. | Count of Participants | Participants |
| |||||||||||||||
| Self-Stigma Scale | Self-stigmatization related to gambling disorder, assessed using the Self-Stigma Scale (SSS), a self-report questionnaire consisting of 36 items (in Turkish version) rated on a Likert-type scale. Total scores range from 36 to 144, with higher scores indicating greater levels of internalized stigma. Baseline assessment was conducted prior to the intervention. Participants scoring above 72 were included in the study. | Mean | Standard Deviation | self stigma scale score |
| ||||||||||||||
| South Oaks Gambling Screen | Gambling severity, assessed using the South Oaks Gambling Screen (SOGS), a self-report screening instrument consisting of 19 items (Turkish version) designed to identify gambling-related problems. Total scores range from 0 to 19, with higher scores indicating greater severity of gambling problems. The scale was administered at baseline and repeated over time to assess changes in gambling severity across the study period. Baseline assessment was conducted prior to the intervention. | Mean | Standard Deviation | South Oaks Gamblin Screen Score |
| ||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | 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. | Posted | Mean | Standard Deviation | Self Stigma Scale Scores | post-treatment (Week 4) and follow-up (Week 8) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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) | 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. | Posted | Mean | Standard Deviation | South Oaks Gambling Screen Scores | post-treatment (Week 4) and follow-up (Week 8) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Mediation Analyze | Mediation analysis was conducted to examine whether [Self Stigma score change, M] mediates the effect of [being intervention group or control group, X] on [south oaks gambling screen score change, Y]. Change scores from baseline (week 0) to post-intervention (week 4) (t1 - t0) were used in the analysis. Used Process Macro Model 4. | Posted | Number | 95% Confidence Interval | beta coefficient -Scores Changes (t1-t0) | Outcome measures at post-intervention (after the fourth session, week 4; T1) were compared to baseline scores (prior to intervention; T0) by calculating change scores as T1 minus T0. |
|
|
from baseline measures until end of follow up, up to 8 weeks
Adverse events were monitored informally through participant self-report and therapist observation during the intervention period. No serious adverse events were anticipated or observed in this behavioral intervention study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG001 | 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. | 0 | 13 | 0 | 13 | 0 | 13 |
Not provided
Not provided
The groups were not fully balanced in baseline gambling severity, which may influence interpretation of the results. The study was not placebo-controlled or blinded, which could affect participant responses. Additionally, the one-month follow-up limits conclusions about the long-term effects of the intervention.Since SSCBT is a newly developed intervention model, further studies with larger and more diverse samples are needed to strengthen the evidence base.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ayça Çınaroğlu Asar | Ege University | 0 543 530 86 83 | aycacinaroglu@icloud.com |
| Dec 20, 2025 |
| Prot_SAP_ICF_001.pdf |
| ID | Term |
|---|---|
| D005715 | Gambling |
| D057545 | Social Stigma |
| ID | Term |
|---|---|
| D012309 | Risk-Taking |
| D001519 | Behavior |
| D007174 | Disruptive, Impulse Control, and Conduct Disorders |
| D001523 | Mental Disorders |
| D012919 | Social Behavior |
Not provided
Not provided
|
|
|
|
|
|
|
|