Clinical trial NCT06943963: The Effect of Self Stigma Tailored Cognitive Behavioral Therapy on Gambling Disorder
Official title: The Effect of Self Stigma Tailored Cognitive Behavioral Therapy on Gambling Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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%.
Primary purpose: TREATMENT

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.

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 Alcohol Use 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.

Eligibility criteria: Inclusion Criteria:

1. Meeting the diagnostic criteria for Gambling Disorder (GD) according to the DSM-5:
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:

1. "Intellectual Disability" classified under neurodevelopmental disorders.
2. "Communication Disorders" resulting from neurodevelopmental disorders or another medical condition.
3. Based on clinical interviews and DSM-5 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.

Primary outcomes:
measure: 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)
timeFrame: baseline (Week 0) to post-treatment (Week 4) and follow-up (Week 8)
measure: 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)
timeFrame: baseline (Week 0) to post-treatment (Week 4) and follow-up (Week 8)
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University
state: Bornova
Study officials:
affiliation: Ege University, Addiction Clinic within the Institute of Addiction, Toxicology, and Pharmaceutical Sciences.
name: Umut Kırlı, Assoc. Prof.
role: STUDY_DIRECTOR
name: Ayça Çınaroğlu Asar, B.A.
role: PRINCIPAL_INVESTIGATOR
References: