Eye Movements Desensitization and Reprocessing (EMDR) Intervention in Preventing Craving in Alcohol Use Disorder: Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Frequency of alcohol craving assessed by Penn Alcohol Craving Scale
研究概览
简要总结
This study is conducted to examine the effect of a psychotherapy model that is expected to affect alcohol cravings in adults aged 18-65 years who are being treated for alcohol use disorder at a clinic. The psychotherapy intervention is expected to affect other variables such as clinical symptom level, self-efficacy level, and functionality level. This protocol is called addiction-focused eye movement desensitization and reprocessing (addiction-focused EMDR). Patients found suitable for the study will be divided into experimental and control groups. The intervention will be applied to the experimental group and not to the control group. At the end of the intervention, the effect of the intervention primarily on the level of craving will be compared with that of the control group. The intervention is expected to reduce the level of craving. The intervention is expected to have an impact on the other variables mentioned as well.
详细描述
The main purpose of this study is to examine the change in craving frequency, craving severity, and level of control over craving in adults who applied to an addiction clinic and diagnosed with alcohol use disorder after having the intervention of addiction-focused eye movements and desensitization and reprocessing (addiction-focused EMDR) therapy. The sub-objectives of the study are to monitor the changes in the clinical symptoms, self-efficacy and general functionality levels of addicted individuals receiving addiction-focused EMDR therapy. The research will be carried out at Ege University Substance Abuse, Toxicology and Pharmaceutical Sciences Institute Addiction Polyclinic. The population of the research consists of individuals between the ages of 18-65 who applied to Ege University Substance Abuse, Toxicology and Pharmaceutical Sciences Institute Addiction Polyclinic and were diagnosed with alcohol use disorder. In order to estimate the effect size and sample size of the research, the data obtained from a reference research were used due to its suitability for the design, purpose and primary output of the research, and the calculations were made on G Power 3.1. Confidence interval was taken as 95% (p<0.05) and power was determined as 80%. As a result of the calculation, the effect size was found to be f: 0.42 and the total number of samples was determined as 30. According to the previous research, the sample loss rate was reported as 33%. When the estimated sample loss at a similar rate is added to the research, the final sample number was determined as 40 patients, 20 patients in the control group and 20 patients in the intervention group. Sociodemographic Form created by the researcher to obtain information about the patients' age, gender, past diagnosis, treatment histories, and medical diseases; Alcohol Use Disorders Identification Test to measure the risk level of alcohol use; Penn Alcohol Craving Scale to measure craving severity and frequency; Craving Experience Scale to measure the level of control over craving; Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) Self-Rated Level 1 Cross-Cutting Symptom Scale to measure the level of clinical symptoms; Childhood Trauma Questionnaire; General Self-Efficacy Scale; The General Assessment of Functioning Scale to measure the level of functionality in the social, occupational and psychological domains will be used to gather the data. Statistical analysis of the data will be performed in Statistical Package for the Social Sciences (SPSS). Repeated measures analysis of variance (ANOVA) test will be used to calculate whether there is a difference between the experimental and control groups in terms of measured variables. The significance value (p) will be taken as 0.05. The results will be presented in tables, reported and discussed within the light of the literature.
Research Duration
The total duration of the research is planned to be 15 months between October 2022 and December 2023. The stages of the research were planned according to weeks (W). The stages of the research and the plan according to the weeks are as follows:
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Sample screening (October 2022, W1-W4) 2. Evaluation session and pre-measurements (October 2022, W2-W4) 3. Randomization and research groups (November 2022, W5-W6) 4. Informing the participants (November 2022, W5-W6) 5. Intervention (psychotherapy sessions) (November 2022-December 2022, W7-W12) 6. Post-measurements (December 2022-January 2023, W11-W13) 7. Follow-up measurements (January 2023-February 2023, W15-W17) 8. Analyzing the data (February 2023, W18-W20) 9. Intervention in the control group (March 2023-April 2023, W22-W29) 10. Reporting (May 2023-December 2023, W30-W60)
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Sample Screening Face-to-face or telephone interviews will be conducted with patients who have applied to Ege University Substance Abuse, Toxicology and Pharmaceutical Sciences Institute Addiction Polyclinic and diagnosed with alcohol use disorder. Meeting appointment for a face-to-face evaluation will be made with the patients who are interested in the research. Preliminary interviews will continue and appointments will be made until the sufficient number of samples is reached. Sample screening and interviews with volunteer patients are expected to be conducted and completed between the first and fourth weeks of October 2022.
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Evaluation Session and Pre-measurements The steps in the evaluation session (clinical evaluation) can be listed as follows.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The randomisation of patients to one of the study arms will be carried out by another researcher other than the researcher who will practice the intervention. With this masking method, it is planned to assign the patients to the groups without any bias of the psychotherapist.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having the criteria for the diagnosis of alcohol use disorder according to DSM-5,
- •Continuing or completing the standard treatment applied in the addiction clinic,
- •Being between the ages of 18-65.
排除标准
- •As a result of the clinical interview, meeting the criteria for any of the disorders included in the classifications of:
- •"Bipolar and related disorders" with psychotic features,
- •"Depression disorders" with psychotic features,
- •"Dissociative disorders" such as depersonalization, derealization, dissociative identity disorder,
- •"Schizophrenia spectrum and disorders leading to psychosis" such as schizophrenia, schizotypal personality disorder, schizoaffective disorder,
- •Receiving any psychological or medical treatment other than the standard alcohol use disorder treatment administered in the Addiction Polyclinic,
- •Having at least one of cardiovascular diseases, vertigo, epilepsy or eye diseases.
结局指标
主要结局
Frequency of alcohol craving assessed by Penn Alcohol Craving Scale
时间窗: The change scores of the frequency of alcohol craving between the control and the experiment groups will be compared between the intervention completion (t1)(estimated to be 8 weeks) and 4-week follow-up (t2).
This outcome refers to the change in scores of the frequency of alcohol craving obtained from measurements at two time points between experiment and control groups. Penn Alcohol Craving Scale is the measurement tool to measure the craving frequency.
Severity of alcohol craving assessed by Penn Alcohol Craving Scale
时间窗: The change scores of the severity level of alcohol craving between the control and the experiment groups will be compared between the intervention completion (t1)(estimated to be 8 weeks) and 4-week follow-up (t2).
This outcome refers to the change in scores of the severity level of alcohol craving obtained from measurements at two time points between experiment and control groups. Penn Alcohol Craving Scale is the measurement tool to measure the level of craving severity.
Control level over alcohol craving assessed by Craving Experience Scale
时间窗: The change scores of the control level over alcohol craving between the control and the experiment groups will be compared between the intervention completion (t1)(estimated to be 8 weeks) and 4-week follow-up (t2).
This outcome refers to the change in scores of the control level over alcohol craving obtained from measurements at two time points between experiment and control groups. Craving Experience Scale is the measurement tool to measure the level of control over craving.
次要结局
- Self-efficacy level assessed by General Self-Efficacy Scale(The change scores of the level of self-efficacy between the control and the experiment groups will be compared between the intervention completion (t1)(estimated to be 8 weeks) and 4-week follow-up (t2).)
- General functioning level assessed by The General Assessment of Functioning Scale(The change scores of the level of general functionality between the control and the experiment groups will be compared between the intervention completion (t1)(estimated to be 8 weeks) and 4-week follow-up (t2).)
- Clinical symptom levels assessed by Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) Self-Rated Level 1 Cross-Cutting Symptom Scale(The change scores of the clinical symptoms between the control and the experiment groups will be compared between the intervention completion (t1)(estimated to be 8 weeks) and 4-week follow-up (t2).)
研究者
Yagmur Callak
Principal Investigator
Ege University