ClinicalTrials.gg
CompletedNCT06943963Updated Feb 5, 2026Results posted

The Effect of Self Stigma Tailored Cognitive Behavioral Therapy on Gambling Disorder

An interventional study of Self Stigma Tailored Cognitive Behavioral Therapy on Gambling Disorder and standart pharmacotherapy in Gambling Addiction, Gambling Disorder and Gambling Disorder Treatment, sponsored by Ege University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by Ege University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Apr 2024, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the detailed description

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:

  1. Sample screening - March 2024, W1-W4
  2. Assessment session and pre-test measurements (March 2024, W2-W4)
  3. Randomization and assignment of research groups (April 2024, W5-W6)
  4. Informing the participants (April 2024, W5-W6)
  5. Intervention (psychotherapy sessions) (April 2024 - September 2024, W7-W20)
  6. Post-test measurements (September 2024 - October 2024, W21-W23)
  7. Follow-up measurements (December 2024 - January 2025, W27-W29)
  8. Data analysis (January 2025, W30-W32)
  9. Reporting (February 2025 - April 2025, W33-W39)

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  1. 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.
  2. 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.
    • Informing the participants that they would be randomly assigned to one of two groups through a randomization program by a researcher other than the primary investigator.
    • Obtaining signed informed consent forms from patients who voluntarily agreed to participate in the study, and providing them with a copy.
    • Taking the anamnesis of patients who agreed to participate voluntarily. Anamnesis information was recorded in the Case Report Form developed by the principal investigator.
    • Administering all scales (Self-Stigma Scale and South Oaks Gambling Screen) to participants with the guidance of the principal investigator. These measurements constitute the baseline (t0) assessments of the study.
    • Informing the participants that they would be contacted again to be informed about their group assignment before the session ends.
  3. 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.
  4. 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.
  5. 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.

    • Explaining the concepts of social stigma and self-stigma.
    • Providing information on Cognitive Behavioral Therapy (CBT).
    • Presenting the cognitive-behavioral model related to self-stigmatization in individuals with Gambling Disorder.
    • Exploring the impact of emotions and cognitive distortions.

    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.
    • Homework 4: Behavioral Experiment Form - Offers an opportunity to challenge and restructure personal cognitions through practical exercises.
    • Homework 5: Relapse Prevention Form - Assists in documenting new experiences and serves as a reminder of session content during the cognitive restructuring phase.

    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.

  6. 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.

  7. 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.
  8. 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
  9. Reporting The research process and findings were documented and presented in tabular format. The reporting phase constituted the final stage of the study.
02

Conditions studied

  • Gambling Addiction
  • Gambling Disorder
  • Gambling Disorder Treatment
  • Stigma
  • Stigma of Mental Illness
  • Self Stigma
  • CBT
  • Cognitive Behavioral Therapy

Keywords

  • self stigma
  • CBT
  • gambling disorder
  • gambling addiction
  • controlled trial
  • therapy
03

In context

Gambling

158 studies on the registry are indexed under Gambling; 42 are open to participants now.

This study's enrollment of 26 is below the median of 66 across 128 interventional studies indexed under Gambling.

Browse Gambling studies →

Lead sponsor

Ege University is the lead sponsor of 377 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Meeting the diagnostic criteria for Gambling Disorder (GD) according to the :
  2. Currently receiving or having completed the standard treatment provided at the outpatient clinic.
  3. Scoring 72 or above on the Self Stigma Scale.
  4. Being between 18 and 65 years old.

Exclusion criteria

Exclusion Criteria:

  1. "Intellectual Disability" classified under neurodevelopmental disorders.
  2. "Communication Disorders" resulting from neurodevelopmental disorders or another medical condition.
  3. Based on clinical interviews and diagnostic criteria:
  4. "Bipolar and Related Disorders" with psychotic features.
  5. "Depressive Disorders" with psychotic features.
  6. "Dissociative Disorders" such as depersonalization, derealization, or identity disruption.
  7. Any disorder classified under "Schizophrenia Spectrum and Other Psychotic Disorders," including schizophrenia, schizotypal personality disorder, and schizoaffective disorder.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Self Stigma Tailored Cognitive Behavioral Therapy on Gambling Disorder · Drug: standart pharmacotherapy · Behavioral: motivational intervention

  • Active comparator
    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.

    Drug: standart pharmacotherapy · Behavioral: motivational intervention

Interventions

  • BehavioralSelf Stigma Tailored Cognitive Behavioral Therapy on Gambling Disorder

    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.

    Also known as: SSCBT

  • Drugstandart pharmacotherapy

    All participants continued to receive standard pharmacotherapy from their respective psychiatrists.

  • Behavioralmotivational intervention

    All participants continued to receive the standard motivational interviewing intervention for addiction from their psychiatrist.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: post-treatment (Week 4) and follow-up (Week 8)

  2. 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.

    Time frame: post-treatment (Week 4) and follow-up (Week 8)

07

Results

Posted Feb 5, 2026
Limitations and caveats
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.

Participant flow

"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.

Participant flow — Overall Study
MilestoneExperimental (Intervention) GroupControl Group
Started1313
Completed1313
Not completed00

Outcome measures

PrimaryChange 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.

Time frame:
post-treatment (Week 4) and follow-up (Week 8)
Reported as:
Mean · Self Stigma Scale Scores
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 Scale ScoresExperimental (Intervention) GroupControl Group
post intervention (t1)82.77 ± 24.43110.3 ± 17
follow up (t2)80.38 ± 21.25105.92 ± 18.78
Statistical analysis
  • Experimental (Intervention) Group vs Control Group · ANOVA · p = <0.05 · Mean difference (net): 0.002
PrimaryChange 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.

Time frame:
post-treatment (Week 4) and follow-up (Week 8)
Reported as:
Mean · South Oaks Gambling Screen Scores
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)
South Oaks Gambling Screen ScoresExperimental (Intervention) GroupControl Group
post intervention (t1)3.77 ± 1.967.38 ± 4.19
follow up (t2)4.46 ± 2.875.31 ± 2.62
Statistical analysis
  • Experimental (Intervention) Group vs Control Group · ANOVA · p = <0.05 · Mean difference (net): 0.0001
Post-hocMediation 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.

Time frame:
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.
Reported as:
Number · beta coefficient -Scores Changes (t1-t0)
Mediation Analyze
beta coefficient -Scores Changes (t1-t0)All Participants
Direct Effect X= group type (intervention or control) to Y= SOGS scores changes-2.11 (-5.17 to 0.94)
X= group type (intervention or control) to M= SSS score changes-32.38 (-45.93 to -18.83)
M= SSS score changes to Y= SOGS scores changes0.14 (0.08 to 0.21)

Adverse events

Collected over from baseline measures until end of follow up, up to 8 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Experimental (Intervention) Group0/13 (0%)0/13 (0%)0/13 (0%)
Control Group0/13 (0%)0/13 (0%)0/13 (0%)

Baseline characteristics

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.

Age, Continuous
Age, Continuous(years)Experimental (Intervention) GroupControl GroupTotal
Mean36.5 ± 9.7730 ± 4.833.25 ± 7.7
Sex: Female, Male
Sex: Female, Male(Participants)Experimental (Intervention) GroupControl GroupTotal
Female022
Male131124
Self-Stigma Scale
Self-Stigma Scale(self stigma scale score)Experimental (Intervention) GroupControl GroupTotal
Mean118.15 ± 13113.31 ± 13115.73 ± 13
South Oaks Gambling Screen
South Oaks Gambling Screen(South Oaks Gamblin Screen Score)Experimental (Intervention) GroupControl GroupTotal
Mean14.25 ± 210.85 ± 1.612.55 ± 1.83
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Experimental (Intervention) GroupControl GroupTotal
Count of participants——0
08

Study locations

1 site
  • Ege University
    Izmir, Bornova 3100, Turkey (Türkiye)
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided — 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.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2024 to primary completion in Sep 2024, 5 months.

Results were first posted in Feb 2026, 1 year 4 months after primary completion.

Of 47 non-industry interventional studies with no phase under Gambling, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 51. This study's 5 months is below that.

Counting every sponsor, half of 47 studies reached it within 16 months; a quarter within 10 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 17, 2025
First posted
Apr 25, 2025
StartActual
Apr 1, 2024
Primary completionActual
Sep 30, 2024
CompletionActual
Nov 30, 2024
Results first posted
Feb 5, 2026
Last update
Feb 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06943963
Lead sponsor
Ege University
Responsible party
Ayça Çınaroğlu Asar (Principal Investigator, Ege University) — Principal investigator
First posted
Apr 25, 2025
Start date
Apr 1, 2024
Primary completion
Sep 30, 2024
Completion
Nov 30, 2024
Results posted
Feb 5, 2026
Last update
Feb 5, 2026

Study contacts

Umut Kırlı, Assoc. Prof.
study director · Ege University, Addiction Clinic within the Institute of Addiction, Toxicology, and Pharmaceutical Sciences.
Ayça Çınaroğlu Asar, B.A.
principal investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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