Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04912414
Status:
COMPLETED
Last Update Posted:
2021-06-03
First Post:
2021-05-26
Brief Title:
Brief Family Therapy BFT for the Treatment of Psychosomatic Symptoms in Rwanda
Sponsor:
University of Rwanda
Organization:
University of Rwanda
Study Overview
Official Title:
Brief Family Therapy BFT for the Treatment of Psychosomatic Symptoms in Rwanda
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Mental health is fundamental part of the human being worldwide taken as the driver of all daily activities of the people Psychosomatic disorders are the psychological diseases that are the burden in mental health worldwide These diseases characterized by the medically unexplained symptomatology MUS are considered as a comprehensive interdisciplinary framework for assessment of psychological factors affecting individual vulnerability as well as course and outcome of illness biopsychosocial consideration of patient care in clinical practice specialist interventions to integrate psychological therapies in the prevention treatment and rehabilitation of medical disease This psychosomatic symptomatology is highly prevalent in developing countries Prior studies stated that Brief family therapy BFT is an effective for MUS Some possible reasons could be solving conflicts and interpersonal problems by means of training certain skills such as problem solving developing relationships with others effective coping assertiveness and positive thinking This quasi-experimental design investigates whether BFT can reduce psychosomatic symptoms in Kibungo referral hospital of Eastern Province Rwanda Experimental group enroll 60 patients who will be followed up during 2 months Control group enroll 60 patients Participants from experimental group will attend 8 sessions of BFT Statistical analyses will be performed using the SPSS software version 22 As recommended by the declaration of Helsinki confidentiality and voluntariness were ensured Informed consents were obtained from the participants Paired-samples t-test will be used for assessing the means differences between two groups before and after the BFT 95 of confidence intervals and 5 of statistical significance are applied In the baseline sociodemographic questionnaire and psychometric tools will be provided The psychometric tools will be used in the baseline and at the end of BFT sessions
Detailed Description:
Background and study aims Medically unexplained symptoms MUS is a diagnosis given to people with long-term physical problems that do not match any recognised medical conditions Psychosomatic symptoms are physical problems such as pain that are a result of- or made worse by- emotional stress or depression In some cases the bodys immune system may be weakened by severe andor chronic stress Psychosomatic symptoms are common and can greatly impact quality of life There are not many treatments for psychosomatic symptoms and treatment of these symptoms are not prioritized as their cause is unexplained by modern medicine
Aim of the study This study aims to investigate whether a brief family therapy program can reduce psychosomatic symptoms in Kibungo referral hospital of Eastern Province Rwanda
Who can participate Adults diagnosed with medically unexplained symptoms MUS What does the study involve Patients transferred to the participating centre for the treatment of psychosomatic symptoms were treated with either Brief Family Therapy BFT or a control treatment for 2 months
Participants were allocated to one of the two groups with an equal chance of being in either group At the start of the study all participants were provided with questionnaires for assessing their baseline characteristics and their expectations about the treatment The participants were also be asked to complete questionnaires about their psychosomatic symptoms and health at the start and at the end of the study What are the possible benefits and risks of participating The benefits of participating were psychological support provided by BFT Benefits will be explained to participants and then provided the consent form for participating in the research
They were also promised that they could withdraw at any time and no asked any reason about their participation Privacy and confidentiality were respected in this study for protecting participants No risks are anticipated from participation in this study
Where is the study run from The study run from University of Rwanda Rwanda and was conducted in the medical setting
Aim of the study This study aims to investigate whether a brief family therapy program can reduce psychosomatic symptoms in Kibungo referral hospital of Eastern Province Rwanda
Who can participate Adults diagnosed with medically unexplained symptoms MUS What does the study involve Patients transferred to the participating centre for the treatment of psychosomatic symptoms were treated with either Brief Family Therapy BFT or a control treatment for 2 months
Participants were allocated to one of the two groups with an equal chance of being in either group At the start of the study all participants were provided with questionnaires for assessing their baseline characteristics and their expectations about the treatment The participants were also be asked to complete questionnaires about their psychosomatic symptoms and health at the start and at the end of the study What are the possible benefits and risks of participating The benefits of participating were psychological support provided by BFT Benefits will be explained to participants and then provided the consent form for participating in the research
They were also promised that they could withdraw at any time and no asked any reason about their participation Privacy and confidentiality were respected in this study for protecting participants No risks are anticipated from participation in this study
Where is the study run from The study run from University of Rwanda Rwanda and was conducted in the medical setting
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None