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临床试验/NCT05564559
NCT05564559已完成不适用

Multifamily Group Psychoeducation for Substance Use Disorders: A Non-randomized Controlled Trial in Turkey

Ege University2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2022年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
2
主要终点
Families' Burden

研究概览

简要总结

The aim of this study is to investigate the effects of multi-family group psychoeducation (MFGP) on the families of people living with a diagnosis of substance abuse disorder on patients and their families.

It has been reported that families are affected by substance-related disorders. Families that are the target of psychoeducational practices for families are defined as follows: "Family" is a relative, biological family member, partner, close friend, or any other support person or a person who sees herself/himself as the patient's family. In most studies, it has been stated that including family members in the patient's treatment provides additional benefits to substance use services and makes long-term recovery more likely. Studies have found that MFGP is associated with fewer relapses and hospitalizations, improved family well-being, increased participation in vocational rehabilitation, higher employment rates, and reduced costs of care. Multifamily psychoeducation aims to increase the family's knowledge about substance use disorders and to include them in the recovery process.

Study Design:The intervention involves 8-week MFGP for families. During the 8 sessions, it was planned to conduct face-to-face psychoeducational group work, with each session lasting 75 minutes on average. The MFGP to be covered during 8 sessions was created by evaluating MFGP modules from 3 different sources.

Intervention protocols included these subjects:

First session: Psychoeducation on Substance-Abuse Disorders Second session: Effects of Addiction on the Family Third session: illness management Fourth session: Supporting Recovery Fifth session: Improving Stress Coping Skills/Stress Management Sixth session: Developing Problem-Solving Skills Seventh session: Strengthening the Family Eighth session: Working with Stigma

Study population: Families of people suffering from substance abuse disorders were studied.

Expected outcomes: An increase in general and social functionality, a decrease in depression, anxiety, and self-stigma, an increase in quality of life, and treatment compliance are expected for patients. For families, it is expected that depression, anxiety, self-stigma, and caregiving burnout decrease, funcitonalty and quality of life increases and people gain skills to cope with stress.

详细描述

Research Method:

The population of the research is all individuals who live in Istanbul and have a relative living with the diagnosis of substance-related disorder. The sample of the study is the families of people living with the diagnosis of substance use disorders. These families are receiving service from Maltepe University Faculty of Medicine AMATEM clinic in Istanbul.

The literature was reviewed to determine the effect size and sample size of the study. Considering the purpose, design, and target audience of the research, the study by Fiorillo et al. was accepted as a reference publication (Fiorillo et al. 2015). Based on the aforementioned study, the t test family calculated the difference between two dependent means (Matched Pair Test) f: 0.31 (exact value: 0.3144855) and the total number of samples was determined as 64. When loss rates are included, the reference publication Fiorillo et al. (2015) stated that the sample loss rate (attrition rate) was 7% for the intervention group and 6% for the control group. The participant loss rate was accepted as 10%. In this case, considering the power analysis and the loss rates in the reference publication, the final sample number for this study was determined as 70 in total, and 35 participants will form the intervention group and 35 participants will form the control group. 35 patient families and patients will be in the intervention group, and 35 patient families and patients will be in the control group. Patients will not receive any intervention, only data collection tools will be measured.

The sample will be selected from the population using the "Convenience Sampling Method'.Families will be informed about this study with the brochure that will be given to them during their outpatient clinic visits. Families who agree to participate in the study will first be presented with the 2 dates specified for the study's intervention and control group/waiting list. Whatever date is found suitable for the families, they will participate in the intervention or control group accordingly. The first set schedule will be the intervention group, and the second will be the control group/waiting list. No measurements will be made after the intervention to the waiting list/control group. During this period, all patients will receive standard treatment.

In the descriptive analysis of the data, the number, percentage, minimum, maximum, mean, and standard deviation values will be given. The Statistical Package for the Social Sciences (SPSS) 24.0 program will be used in the analysis of the data. The significance level will be set at p<0.05. An Analysis of Variance (ANOVA) test will be performed for repeated measurements.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Families' Burden

时间窗: The change scores of the control and intervention groups between the baseline measure and pscyhoeducation completion (estimated to be 12 weeks) will be compared.

People with relatives living with serious mental illness may experience burnout due to caregiving. Eight weeks of multifamily psychoeducation is expected to reduce the burnout caused by caregiving. Caregiver burnout will be measured with the Zarit Caregiver Burden Scale. The scale, on which the burden of caregivers of individuals with serious mental illness is evaluated, consists of 19 items. The scale is in a 5-point Likert type and the score that can be obtained from the scale varies between 19 and 95 points. As the scores obtained from the scale increase, the severity of the burden also increases.

次要结局

  • Social Functioning(The change scores of the control and intervention groups between the baseline measure and pscyhoeducation completion (estimated to be 12 weeks) will be compared.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

BEYZA NUR KAYTAZ YILMAZ

Principal Investigator

Ege University

研究点 (2)

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