Clinical trial NCT05564559: Multifamily Group Psychoeducation for SUD's in Turkey
Official title: Multifamily Group Psychoeducation for Substance Use Disorders: A Non-randomized Controlled Trial in Turkey
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disease
Mental Disorders, Severe
Substance-Related Disorders
Substance Use Disorders
Alcohol Use Disorder
Keywords: multi-family psychoeducation
substance abuse disorder
group psychoeducation
group study
family psychoeducation
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a 2-arm, non-randomized clinical study consisting of an intervention and a control group (waiting list) aiming to provide 8 weeks of multi-family psychoeducation to the families of people living with a diagnosis of substance abuse disorder.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Pre-Intervention: Introducing the study to families and giving informed consent forms to families are among the procedures at this stage. In addition, at this stage, a 45-minute pre-interview will be held in order to assign one of the intervention or control (waiting list) groups according to the working schedule of the families who agreed to participate in the study and to take pre-test measurements before the intervention.

Intervention: A previously standardized 8-week multi-family group psychoeducation protocol is applied to the intervention group. Meanwhile, the control group is on the waiting list.

Post-intervention: At the end of the intervention, post-tests are applied to the intervention group and control group. After this stage of the study, an intervention is also applied to the control group on the waiting list. The data collection phase of the study will be over after the intervention has been given to the intervention group and the post-test measurements have been made. No measurements will be taken after the intervention is applied to the control group.

Eligibility criteria: Inclusion Criteria

for patients:

* From 18 to 64 years old.
* Living with a diagnosis of substance use disorders according to DSM-5.
* Agree to be participants in the study.

for families:

-Identifying as a relative/family member of someone living with a substance use disorder.

Exclusion Criteria

for patients:

* Patients with impaired thinking and perception.
* Be over 65 years old. Having problems with Turkish language skills.
* Living with another physical illness that caused disability.
* Living with another severe mental illness that causes disability (Schizophrenia, schizoaffective disorder, epilepsy, etc.).

for families:

* Living with a mental disability.
* Living with a substance use disorder diagnosis.
* Having difficulties with Turkish language skills.

Primary outcomes:
measure: Families' Burden
timeFrame: The change scores of the control and intervention groups between the baseline measure and pscyhoeducation completion (estimated to be 12 weeks) will be compared.
Secondary outcomes:
measure: Social Functioning
timeFrame: The change scores of the control and intervention groups between the baseline measure and pscyhoeducation completion (estimated to be 12 weeks) will be compared.
Other outcomes:
measure: Quality of Life Assessment
timeFrame: The change scores of the families' control and intervention groups between the baseline measure and pscyhoeducation completion (estimated to be 12 weeks) will be compared.
measure: Quality of Life Assessment
timeFrame: The change scores of the patients' control and intervention groups between the baseline measure and pscyhoeducation completion (estimated to be 12 weeks) will be compared.
measure: Depression for Families
timeFrame: The change scores of the families' control and intervention groups between the baseline measure and pscyhoeducation completion (estimated to be 12 weeks) will be compared.
measure: Depression for Patients
timeFrame: The change scores of the patients' control and intervention groups between the baseline measure and pscyhoeducation completion (estimated to be 12 weeks) will be compared.
measure: Anxiety for Patients
timeFrame: The change scores of the patients' control and intervention groups between the baseline measure and pscyhoeducation completion (estimated to be 12 weeks) will be compared.
measure: Anxiety for Families
timeFrame: The change scores of the families' control and intervention groups between the baseline measure and pscyhoeducation completion (estimated to be 12 weeks) will be compared.
measure: Stress Coping Skills
timeFrame: The change scores of the control and intervention groups between the baseline measure and pscyhoeducation completion (estimated to be 12 weeks) will be compared.
measure: Self Stigma for Families
timeFrame: The change scores of the control and intervention groups between the baseline measure and pscyhoeducation completion (estimated to be 12 weeks) will be compared.
measure: Self Stigma for Patients
timeFrame: The change scores of the control and intervention groups between the baseline measure and pscyhoeducation completion (estimated to be 12 weeks) will be compared.
measure: Group Attendance
timeFrame: In intervention (weeks 1 to 8)
Locations:
city: Istanbul
country: Turkey
facility: Maltepe University Faculty of Medicine Hospital, Alcohol and Substance Addiction Treatment Center
Study officials:
affiliation: Ege University
name: Zeki Yüncü
role: STUDY_DIRECTOR
References:
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citation: Dixon L, McFarlane WR, Lefley H, Lucksted A, Cohen M, Falloon I, Mueser K, Miklowitz D, Solomon P, Sondheimer D. Evidence-based practices for services to families of people with psychiatric disabilities. Psychiatr Serv. 2001 Jul;52(7):903-10. doi: 10.1176/appi.ps.52.7.903.
citation: Center for Substance Abuse Treatment. Substance Abuse Treatment and Family Therapy. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 2004. Report No.: (SMA) 04-3957. Available from http://www.ncbi.nlm.nih.gov/books/NBK64265/