NCT05089552

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 10, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

January 3, 2023

Status Verified

December 1, 2022

Enrollment Period

7 months

First QC Date

October 10, 2021

Last Update Submit

December 29, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • quality of life evaluation

    evaluation of quality of life by WHO-QOL-BREFF scale

    2 weeks

  • psychiatric symptoms

    evaluation of psychiatric symptoms by Symptom Checklist-90-Revised (SCL-90-R)

    12-15 minutes

Interventions

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

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.

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Family caregivers of addicts who come to an addiction clinic and unit of neuropsychiatry hospital of assiut university hospital

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 28607798BACKGROUND
  • The 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.

    PMID: 8560308BACKGROUND
  • Settley 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.

    PMID: 32513458BACKGROUND
  • Rafiq 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.

    PMID: 31511715BACKGROUND

MeSH Terms

Conditions

Behavior, Addictive

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Saleh Ahmed Mahmoud, Resident

    Assiut University

    PRINCIPAL INVESTIGATOR
  • ALaa EL-DIN Mohamed darweesh, MD

    Assiut University

    STUDY CHAIR
  • Mohamed Fawzy Mohamed, AP

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

ALaa EL-DIN Mohamed darweesh, MD

CONTACT

Mohamed Fawzy Mohamed, AP

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 10, 2021

First Posted

October 22, 2021

Study Start

January 1, 2023

Primary Completion

August 1, 2023

Study Completion

October 1, 2023

Last Updated

January 3, 2023

Record last verified: 2022-12

Locations