NCT06943963

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 25, 2025

Completed
10 months until next milestone

Results Posted

Study results publicly available

February 5, 2026

Completed
Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

April 17, 2025

Results QC Date

December 3, 2025

Last Update Submit

January 20, 2026

Conditions

Keywords

self stigmaCBTgambling disordergambling addictioncontrolled trialtherapy

Outcome Measures

Primary Outcomes (2)

  • 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)

Study Arms (2)

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.

Behavioral: Self Stigma Tailored Cognitive Behavioral Therapy on Gambling DisorderDrug: standart pharmacotherapyBehavioral: motivational intervention

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.

Drug: standart pharmacotherapyBehavioral: motivational intervention

Interventions

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
Experimental (Intervention) Group

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

Control GroupExperimental (Intervention) Group

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

Control GroupExperimental (Intervention) Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • "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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Izmir, Bornova, 3100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

GamblingSocial Stigma

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental DisordersSocial Behavior

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.

Results Point of Contact

Title
Ayça Çınaroğlu Asar
Organization
Ege University

Study Officials

  • 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

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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%.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 17, 2025

First Posted

April 25, 2025

Study Start

April 1, 2024

Primary Completion

September 30, 2024

Study Completion

November 30, 2024

Last Updated

February 5, 2026

Results First Posted

February 5, 2026

Record last verified: 2026-01

Locations