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Quality of Life of Caregivers of Addicts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05089552
Recruitment Status : Not yet recruiting
First Posted : October 22, 2021
Last Update Posted : January 3, 2023
Information provided by (Responsible Party):
Saleh Sharkawy, Assiut University

Brief Summary:

American Society of Addiction Medicine defined Addiction as a treatable, chronic medical disease involving complex interactions among brain circuits, genetics, the environment, and an individual's life experiences. People with addiction use substances or engage in behaviors that become compulsive and often continue despite harmful consequences.

Addiction is considered as a "family disease." Addiction affects the individual as well as those around them in terms of occupational and social dysfunction, physical and emotional distress, and financial burden which has a serious impact on the lives of the significant others.

Condition or disease Intervention/treatment
Addiction Other: 1-WHOQOL-BREF(WHO-Quality of life-BREFF) Arabic version Scale Other: SCL-90-R(Symptoms Checklist-90-Revised) Arabic version scale Other: addiction severity index

Detailed Description:

Addiction is a multifaceted problem- it negatively alters the quality of life of not only addicts but also the family members who live with them. Caregiving to an individual suffering from addiction is physically, mentally, socially and emotionally challenging. These caregivers are most burdened as the assistance they provide is multidimensional.

The Quality of Life Group of the World Health Organization (WHO) Division of Mental Health has defined QOL as "an individual's perception of their position in life in the context of the culture and value system in which they live and in relation to their goals, expectations, standards, and concerns " .

Family members are not all equally affected and they suffer in different degrees based on their closeness to the addict and distance from the addict's behavior. Most of the time, a member of the family assumes the role of caregiver, and he or she is most burdened from this process.

The Family Caregiver Alliance (2014) defines family (or informal) caregivers as "any relative, partner, friend, or neighbor who has a significant personal relationship with, and provides a broad range of assistance for, an older person or an adult with a chronic or disabling condition" .

Researchers have described addiction as one of the significant causes of family destruction and disturbed relationship.Family relationships are at risk owing to addiction and associated hazards. Researches addressing the health issues of families have reported numerous mental health problems among children and spouses of addicts. A study has depicted children of addict fathers experiencing depression, anxiety and hypomania. Children of addicts also suffered from different internalised and externalised problem in men.

However, published studies on family caregivers of addicts are limited. This study aimed to evaluate QOL and psychiatric symptoms in family caregivers of addicts.

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Psychiatric Assessment and Quality of Life of Family Caregivers of Addicts
Estimated Study Start Date : January 1, 2023
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Intervention Details:
  • Other: 1-WHOQOL-BREF(WHO-Quality of life-BREFF) Arabic version Scale
    WHOQOL-BREF(WHO-Quality of life-BREFF) Arabic version Scale The WHOQOL-BREF is composed of 26 self-administered items. Using a 5-point Likert response scale ranging from 1 (very dissatisfied/very poor) to 5 (very satisfied/very good), family caregivers were asked to rank each item accordingly. Caregivers were asked to respond to the items indicating their assessment of QOL during the preceding 2 weeks, Ohaeri and Awadalla developed and tested the Arabic version of the WHOQOL-BREF among an Arab population in Kuwait. The translated Arabic WHOQOL-BREF has considerable reliability and validity indices . As reported in the Kuwaiti study, a satisfactory (≥0.7) Cronbach's alpha was reported for the full questionnaire and the domains
  • Other: SCL-90-R(Symptoms Checklist-90-Revised) Arabic version scale
    developed by Derogatis et al. and El-Behairy. established the validity and reliability of the Arabic version.SCL-90-R is a 90-item self-report symptom inventory, and reflect the psychologic symptom pattern of psychiatric and medical patients. Each item of the "90" is rated on a five-point scale of distress (0-4), ranging from "not at all" to "extremely".Under usual circumstances, SCL-90-R requires between 12 and 15 minutes to be completed.SCL-90-R is a measure of the current psychologic symptom status. It is not a measure of personality, except indirectly, in that certain personality disorders may manifest a characteristic profile on the primary symptom dimensions.
  • Other: addiction severity index
    a semi-structured interview that takes approximately 45 minute. developed to evaluate treatment outcome in substance abusers. The instrument focuses on seven areas that are typically affected in the lives of substance abusers: medical status, employment, drug use, alcohol use, legal status, family/social status, and psychiatric status. Information regarding frequency, duration, and severity of problems in these seven areas is collected for both lifetime and recent (past 30 days) history. The ASI provides two types of scores: severity and subjective ratings of the client's need for treatment, and composite scores of problem severity during the prior 30 days. Specific alcohol-related questions include total lifetime years of use, money spent on alcohol, and number of days that alcohol problems are experienced.

Primary Outcome Measures :
  1. quality of life evaluation [ Time Frame: 2 weeks ]
    evaluation of quality of life by WHO-QOL-BREFF scale

  2. psychiatric symptoms [ Time Frame: 12-15 minutes ]
    evaluation of psychiatric symptoms by Symptom Checklist-90-Revised (SCL-90-R)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Family caregivers of addicts who come to an addiction clinic and unit of neuropsychiatry hospital of assiut university hospital

Inclusion Criteria:

  • As defined by The Family Caregiver Alliance (2014) "any relative, partner, friend, or neighbor who has a significant personal relationship with, and provides a broad range of assistance for, an older person or an adult with a chronic or disabling condition" .
  • aged ≥18 years old.
  • being a family caregiver for more than three months (considered the minimum time for the caregivers to be able to feel the effects of care).
  • living or residing near the drug-dependent.

Exclusion Criteria:

  • who stopped living in the city
  • the presence of previous psychiatric illness and caregiver who was also addicts. • Refuse to participate in the research

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05089552

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Contact: ALaa EL-DIN Mohamed darweesh, MD 01005279326
Contact: Mohamed Fawzy Mohamed, AP 01014363839

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Assiut University
Assiut, Egypt, 71515
Contact: Vice president of graduate studies Of Assiut University    +2088 22080150   
Sponsors and Collaborators
Assiut University
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Principal Investigator: Saleh Ahmed Mahmoud, Resident Assiut University
Study Chair: ALaa EL-DIN Mohamed darweesh, MD Assiut University
Study Director: Mohamed Fawzy Mohamed, AP Assiut University
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Responsible Party: Saleh Sharkawy, principal investigator, Assiut University Identifier: NCT05089552    
Other Study ID Numbers: qolfc
First Posted: October 22, 2021    Key Record Dates
Last Update Posted: January 3, 2023
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No