AddictionNCT05089552
Quality of Life of Caregivers of Addicts
An observational study of Addiction, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Addiction
- What is being tested?
- 1-WHOQOL-BREF(WHO-Quality of life-BREFF) Arabic version Scale, SCL-90-R(Symptoms Checklist-90-Revised) Arabic version scale and addiction severity index
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Family caregivers of addicts who come to an addiction clinic and unit of neuropsychiatry hospital of assiut university hospital
Who may be able to join
- 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.
Who cannot join
- who stopped living in the city
- the presence of previous psychiatric illness and caregiver who was also addicts. • Refuse to participate in the research
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut University
Asyut, 71515
Vice president of graduate studies Of Assiut University, +2088 22080150, vp_grad@aun.edu.eg
About this study
Official title: Psychiatric Assessment and Quality of Life of Family Caregivers of Addicts
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.
Read the 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.
- Conditions
- Addiction
- Being tested
- 1-WHOQOL-BREF(WHO-Quality of life-BREFF) Arabic version Scale, SCL-90-R(Symptoms Checklist-90-Revised) Arabic version scale, addiction severity index
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-WHOQOL-BREF(WHO-Quality of life-BREFF) Arabic version ScaleOther
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
SCL-90-R(Symptoms Checklist-90-Revised) Arabic version scaleOther
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.
addiction severity indexOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life evaluation
evaluation of quality of life by WHO-QOL-BREFF scale
Measured: 2 weeks
psychiatric symptoms
evaluation of psychiatric symptoms by Symptom Checklist-90-Revised (SCL-90-R)
Measured: 12-15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start1 Jan 2023 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AddictionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saleh Sharkawy, Assiut University
- Investigators
- Saleh Ahmed Mahmoud, Resident, Principal investigator, Assiut UniversityALaa EL-DIN Mohamed darweesh, MD, Study chair, Assiut UniversityMohamed Fawzy Mohamed, AP, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089552
- Sponsor's protocol ID
- qolfc
- Status last verified
- Dec 2022
- First submitted
- 10 Oct 2021
- Last updated
- 3 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vaishnavi R, Karthik MS, Balakrishnan R, Sathianathan R. Caregiver Burden in Alcohol Dependence Syndrome. J Addict. 2017;2017:8934712. doi: 10.1155/2017/8934712. Epub 2017 May 21.
PubMed 28607798The World Health Organization Quality of Life assessment (WHOQOL): position paper from the World Health Organization. Soc Sci Med. 1995 Nov;41(10):1403-9. doi: 10.1016/0277-9536(95)00112-k.
PubMed 8560308Settley C. The physical and psychological wellbeing of caregivers of individuals suffering from substance addiction. Arch Psychiatr Nurs. 2020 Jun;34(3):107-109. doi: 10.1016/j.apnu.2020.03.007. Epub 2020 Mar 12.
PubMed 32513458Rafiq M, Sadiq R. Caregiver Stress, Perceived Stigma and Mental Health in Female Family Members of Drug Addicts: Correlational Study. J Pak Med Assoc. 2019 Sep;69(9):1300-1303.
PubMed 31511715
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatric Assessment and Quality of Life of Family Caregivers of Addicts
- ClinicalTrials.gov ID
- NCT05089552
- Acronym / sponsor ID
- qolfc
- Conditions
- Addiction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Family caregivers of addicts who come to an addiction clinic and unit of neuropsychiatry hospital of assiut university hospital
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- who stopped living in the city
- the presence of previous psychiatric illness and caregiver who was also addicts. • Refuse to participate in the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1-WHOQOL-BREF(WHO-Quality of life-BREFF) Arabic version ScaleWHOQOL-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 scaledeveloped 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 indexa 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. | Other | – |
Primary outcome
quality of life evaluation
Time frame: 2 weeks
evaluation of quality of life by WHO-QOL-BREFF scale
psychiatric symptoms
Time frame: 12-15 minutes
evaluation of psychiatric symptoms by Symptom Checklist-90-Revised (SCL-90-R)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2023.
- Background: PubMed 28607798Vaishnavi R, Karthik MS, Balakrishnan R, Sathianathan R. Caregiver Burden in Alcohol Dependence Syndrome. J Addict. 2017;2017:8934712. doi: 10.1155/2017/8934712. Epub 2017 May 21.
- Background: PubMed 8560308The World Health Organization Quality of Life assessment (WHOQOL): position paper from the World Health Organization. Soc Sci Med. 1995 Nov;41(10):1403-9. doi: 10.1016/0277-9536(95)00112-k.
- Background: PubMed 32513458Settley C. The physical and psychological wellbeing of caregivers of individuals suffering from substance addiction. Arch Psychiatr Nurs. 2020 Jun;34(3):107-109. doi: 10.1016/j.apnu.2020.03.007. Epub 2020 Mar 12.
- Background: PubMed 31511715Rafiq M, Sadiq R. Caregiver Stress, Perceived Stigma and Mental Health in Female Family Members of Drug Addicts: Correlational Study. J Pak Med Assoc. 2019 Sep;69(9):1300-1303.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saleh Ahmed Mahmoud, Resident principal investigator
Assiut University
ALaa EL-DIN Mohamed darweesh, MD study chair
Assiut University
Mohamed Fawzy Mohamed, AP study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Addiction, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ALaa EL-DIN Mohamed darweesh, MD (01005279326, assiutbird25@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life evaluation (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05089552, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2023.