NCT05564559

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

October 10, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

10 months

First QC Date

September 27, 2022

Last Update Submit

September 6, 2023

Conditions

Keywords

multi-family psychoeducationsubstance abuse disordergroup psychoeducationgroup studyfamily psychoeducation

Outcome Measures

Primary Outcomes (1)

  • Families' Burden

    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.

    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 (1)

  • 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.

Other Outcomes (10)

  • Quality of Life Assessment

    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.

  • Quality of Life Assessment

    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.

  • Depression for Families

    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.

  • +7 more other outcomes

Study Arms (2)

MFGP intervention

EXPERIMENTAL

This group will provide 8 weeks of multi-family psychoeducation to the families of people living with a diagnosis of substance abuse disorder.

Other: multifamily group psychoeducation

Wait list-control group

NO INTERVENTION

This group will provide 8 weeks of multi-family psychoeducation to the families of people living with a diagnosis of substance abuse disorder after the intervention group is completed. This group is the control group on the waiting list.

Interventions

The intervention involves 8 weeks of multifamily psychoeducation for families. Duration of sessions: 75 minutes on average Context: 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 Preferred approach: face-to-face, multi-family Approach: Psychoeducation

MFGP intervention

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maltepe University Faculty of Medicine Hospital, Alcohol and Substance Addiction Treatment Center

Istanbul, 34854, Turkey (Türkiye)

Location

Related Publications (7)

  • Copello AG, Velleman RD, Templeton LJ. Family interventions in the treatment of alcohol and drug problems. Drug Alcohol Rev. 2005 Jul;24(4):369-85. doi: 10.1080/09595230500302356.

    PMID: 16234133BACKGROUND
  • Fiorillo A, Del Vecchio V, Luciano M, Sampogna G, De Rosa C, Malangone C, Volpe U, Bardicchia F, Ciampini G, Crocamo C, Iapichino S, Lampis D, Moroni A, Orlandi E, Piselli M, Pompili E, Veltro F, Carra G, Maj M. Efficacy of psychoeducational family intervention for bipolar I disorder: A controlled, multicentric, real-world study. J Affect Disord. 2015 Feb 1;172:291-9. doi: 10.1016/j.jad.2014.10.021. Epub 2014 Oct 22.

    PMID: 25451428BACKGROUND
  • Lucksted A, McFarlane W, Downing D, Dixon L. Recent developments in family psychoeducation as an evidence-based practice. J Marital Fam Ther. 2012 Jan;38(1):101-21. doi: 10.1111/j.1752-0606.2011.00256.x. Epub 2011 Oct 12.

    PMID: 22283383BACKGROUND
  • McGovern R, Smart D, Alderson H, Araujo-Soares V, Brown J, Buykx P, Evans V, Fleming K, Hickman M, Macleod J, Meier P, Kaner E. Psychosocial Interventions to Improve Psychological, Social and Physical Wellbeing in Family Members Affected by an Adult Relative's Substance Use: A Systematic Search and Review of the Evidence. Int J Environ Res Public Health. 2021 Feb 12;18(4):1793. doi: 10.3390/ijerph18041793.

    PMID: 33673199BACKGROUND
  • McFarlane WR, Link B, Dushay R, Marchal J, Crilly J. Psychoeducational multiple family groups: four-year relapse outcome in schizophrenia. Fam Process. 1995 Jun;34(2):127-44. doi: 10.1111/j.1545-5300.1995.00127.x.

    PMID: 7589414BACKGROUND
  • 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.

    PMID: 11433107BACKGROUND
  • 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/

    PMID: 22514845BACKGROUND

Related Links

MeSH Terms

Conditions

DiseaseMental DisordersSubstance-Related DisordersAlcoholism

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsChemically-Induced DisordersAlcohol-Related Disorders

Study Officials

  • Zeki Yüncü

    Ege University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 27, 2022

First Posted

October 3, 2022

Study Start

October 10, 2022

Primary Completion

August 1, 2023

Study Completion

August 30, 2023

Last Updated

September 7, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations