Ege University, Substance Abuse, Toxicology and Pharmaceutical Sciences Institute
Izmir, 35040, Turkey (Türkiye)
NCT Number: NCT05606900
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Izmir, 35040, Turkey (Türkiye)
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:
Patients who participate in the evaluation interview will be informed in detail about the content of the research. It will be stated that the participants will be randomly divided into two groups via a randomisation program by another researcher. Patients who accept to participate in the research will have to sign a standard informed consent form and a copy of which will be given to them.
The anamnesis of the patients who voluntarily agreed to participate in the research will be taken. Anamnesis information will be recorded in the Sociodemographic Form prepared by the primary researcher.
All scales (Alcohol Use Disorders Identification Test, Penn Alcohol Craving Scale, Craving Experience Scale, DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Scale, Childhood Trauma Questionnaire, General Self-Efficacy Scale, The General Assessment of Functioning Scale) will be applied to the patients in company with the primary researcher. These measurements are the pre-measurements of the research (t0).
Patients will be informed to be contacted again in order to inform them about which group they are in, before the session will be ended.
Each psychotherapy session will be based on addiction-focused processing of the standard EMDR protocol. In the first session a memory of alcohol craving, in the second session a current trigger for craving, and in the last session a future craving situation will be processed. The content to be processed in sessions will be determined according to the information received from the patients.
Participants who attend only one or two psychotherapy sessions will not be deemed to have completed the intervention. Participants who attend all three sessions will be deemed to have completed the intervention.
Standard treatment (TAU): During the period of AF-EMDR intervention, all patients in the experimental and control groups will continue to receive TAU from the addiction outpatient clinic. The content and duration of TAU will be determined for each patient by the clinic's psychiatrist. TAU basically consists of medical treatment and motivational interviews when necessary.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
AF-EMDR includes desensitization and functional reprocessing of the targeted memory or the moment with lateral eye movements. In each session of the psychotherapy, which will be applied as 3 sessions, a memory or a moment that causes alcohol craving will be practised. The processing will continue until the patient becomes desensitized to the memory or the moment that cause the craving. In the first session, a memory of craving will be discussed, in the second session a current trigger that causes craving, and in the third session, a moment that is thought to cause craving in the future will be focused.
Time frame: The change scores of the frequency of alcohol craving between the control and the experiment groups will be compared between the baseline measure (t0) and the intervention completion (t1)(estimated to be 8 weeks).
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.
Time frame: 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.
Time frame: The change scores of the severity level of alcohol craving between the control and the experiment groups will be compared between the baseline measure (t0) and the intervention completion (t1)(estimated to be 8 weeks).
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.
Time frame: 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.
Time frame: The change scores of the control level over alcohol craving between the control and the experiment groups will be compared between the baseline measure (t0) and the intervention completion (t1)(estimated to be 8 weeks).
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.
Time frame: 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.
Time frame: The change scores of the clinical symptoms between the control and the experiment groups will be compared between the baseline measure (t0) and the intervention completion (t1)(estimated to be 8 weeks).
This outcome refers to the difference in scores of the clinical symptoms including depression, anger, mania, anxiety, somatic symptoms, suicidal ideation, psychosis, sleep problems, memory, repetitive thoughts and behaviors, and dissociation obtained from measurements at two time points between experiment and control groups. Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) Self-Rated Level 1 Cross-Cutting Symptom Scale is the measurement tool to measure the level of clinical symptoms. The total score in each sub-domain differs and yet 2 points and above in each sub-domain indicates moderate severity except the domains of suicidal ideation and psychosis of which 1 point is considered severe.
Time frame: 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).
This outcome refers to the difference in scores of the clinical symptoms including depression, anger, mania, anxiety, somatic symptoms, suicidal ideation, psychosis, sleep problems, memory, repetitive thoughts and behaviors, and dissociation obtained from measurements at two time points between experiment and control groups. Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) Self-Rated Level 1 Cross-Cutting Symptom Scale is the measurement tool to measure the level of clinical symptoms. The total score in each sub-domain differs and yet 2 points and above in each sub-domain indicates moderate severity except the domains of suicidal ideation and psychosis of which 1 point is considered severe.
Time frame: The change scores of the level of self-efficacy between the control and the experiment groups will be compared between the baseline measure (t0) and the intervention completion (t1)(estimated to be 8 weeks).
This outcome refers to the chance in scores of the self-efficacy obtained from measurements at two time points between experiment and control groups. General Self-Efficacy Scale is the measurement tool to measure the level of self-efficacy.
Time frame: 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).
This outcome refers to the chance in scores of the self-efficacy obtained from measurements at two time points between experiment and control groups. General Self-Efficacy Scale is the measurement tool to measure the level of self-efficacy.
Time frame: The change scores of the level of general functionality between the control and the experiment groups will be compared between the baseline measure (t0) and the intervention completion (t1)(estimated to be 8 weeks).
This outcome refers to the change in scores of the general functionality in the social, occupational and psychological domains obtained from measurements at two time points between experiment and control groups. The General Assessment of Functioning Scale is the measurement tool to measure the level of general functioning.
Time frame: 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).
This outcome refers to the change in scores of the general functionality in the social, occupational and psychological domains obtained from measurements at two time points between experiment and control groups. The General Assessment of Functioning Scale is the measurement tool to measure the level of general functioning.
Ege University
Other
Eye Movements Desensitization and Reprocessing (EMDR) Intervention in Preventing Craving in Alcohol Use Disorder: Randomized Controlled Study
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