Trial Outcomes & Findings for The Effect of Self Stigma Tailored Cognitive Behavioral Therapy on Gambling Disorder (NCT NCT06943963)
NCT ID: NCT06943963
Last Updated: 2026-02-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
post-treatment (Week 4) and follow-up (Week 8)
Results posted on
2026-02-05
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental (Intervention) Group
n=13 Participants
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
n=13 Participants
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.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.5 years
STANDARD_DEVIATION 9.77 • n=13 Participants
|
30 years
STANDARD_DEVIATION 4.8 • n=13 Participants
|
33.25 years
STANDARD_DEVIATION 7.7 • n=26 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=13 Participants
|
2 Participants
n=13 Participants
|
2 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=13 Participants
|
11 Participants
n=13 Participants
|
24 Participants
n=26 Participants
|
|
Self-Stigma Scale
|
118.15 self stigma scale score
STANDARD_DEVIATION 13 • n=13 Participants
|
113.31 self stigma scale score
STANDARD_DEVIATION 13 • n=13 Participants
|
115.73 self stigma scale score
STANDARD_DEVIATION 13 • n=26 Participants
|
|
South Oaks Gambling Screen
|
14.25 South Oaks Gamblin Screen Score
STANDARD_DEVIATION 2 • n=13 Participants
|
10.85 South Oaks Gamblin Screen Score
STANDARD_DEVIATION 1.6 • n=13 Participants
|
12.55 South Oaks Gamblin Screen Score
STANDARD_DEVIATION 1.83 • n=26 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental (Intervention) Group
n=13 Participants
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
n=13 Participants
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.
|
|---|---|---|
|
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)
post intervention (t1)
|
82.77 Self Stigma Scale Scores
Standard Deviation 24.43
|
110.3 Self Stigma Scale Scores
Standard Deviation 17
|
|
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)
follow up (t2)
|
80.38 Self Stigma Scale Scores
Standard Deviation 21.25
|
105.92 Self Stigma Scale Scores
Standard Deviation 18.78
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental (Intervention) Group
n=13 Participants
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
n=13 Participants
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.
|
|---|---|---|
|
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)
post intervention (t1)
|
3.77 South Oaks Gambling Screen Scores
Standard Deviation 1.96
|
7.38 South Oaks Gambling Screen Scores
Standard Deviation 4.19
|
|
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)
follow up (t2)
|
4.46 South Oaks Gambling Screen Scores
Standard Deviation 2.87
|
5.31 South Oaks Gambling Screen Scores
Standard Deviation 2.62
|
POST_HOC outcome
Timeframe: 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.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.
Outcome measures
| Measure |
Experimental (Intervention) Group
n=26 Participants
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
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.
|
|---|---|---|
|
Mediation Analyze
Direct Effect X= group type (intervention or control) to Y= SOGS scores changes
|
-2.11 beta coefficient -Scores Changes (t1-t0)
Interval -5.17 to 0.94
|
—
|
|
Mediation Analyze
X= group type (intervention or control) to M= SSS score changes
|
-32.38 beta coefficient -Scores Changes (t1-t0)
Interval -45.93 to -18.83
|
—
|
|
Mediation Analyze
M= SSS score changes to Y= SOGS scores changes
|
0.14 beta coefficient -Scores Changes (t1-t0)
Interval 0.08 to 0.21
|
—
|
Adverse Events
Experimental (Intervention) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place