Patient EngagementNCT04912414
Brief Family Therapy (BFT) for the Treatment of Psychosomatic Symptoms in Rwanda
A study testing Brief Family Therapy (BFT) in people with Patient Engagement, run by University of Rwanda at 2 sites in Rwanda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Patient Engagement
- What is being tested?
- Brief Family Therapy (BFT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesRwanda
- Study dates
- 1 Mar 2020to 30 Dec 2020
- Phase
- Interventional
- 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 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being aged 18-59 years
- Being diagnosed Medically Unexplained Symptoms at least more than once with the similar symptoms.
- Being with psychosomatic at least more than 6 months
Who cannot join
- Having no will to participate in the study;
- Not signing the informed consents to participate
Trial locations and contacts
2 sites in 1 country.
Rwanda2 sites
University of Rwanda
Kigali, P.O BOX: 4285 Kigali-Rwanda
University of Rwanda
Kigali
About this study
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.
Read the 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 body's immune system may be weakened by severe and/or 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.
- Conditions
- Patient Engagement
- Being tested
- Brief Family Therapy (BFT)
- Keywords
- Psychosomatic symptom, Anxiety, Brief Family Therapy, Session
- Medical subject headings
- Patient Participation, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Family Therapy (BFT)Behavioural
Patients transferred to the hospital for the treatment of psychosomatic symptoms was randomized (1:1) to receive either Brief Family Therapy (BFT) or a control treatment. Some participants randomized to the BFT arm receive a combination of chemotherapy and BFT and others receive only BFT. BFT comprises 10 sessions using a generic model of problem formation and resolution. This psychotherapy is useful for treating individual, couple, and family problems. Its broad applicability is based on its view that the client's complaint is the problem, not a symptom of something else BFT views behavior, especially a client's problematic behavior, as a function of interaction with other people. After randomization, all participants were asked to complete questionnaires about their psychosomatic symptoms and health at baseline, at the end of the intervention (at 4 months).
| Study group | Role | What they receive |
|---|---|---|
| Brief Family Therapy (BFT) for the treatment of psychosomatic symptoms in Rwanda | Experimental | The participants from the control group were assigned to the Brief Family Therapy for reducing the medically unexplained symptoms. But the control group was not assigned to the intervention (BFT). Receives: Behavioral: Brief Family Therapy (BFT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychosomatic Symptom Checklist (PSC-17)
Psychosomatic Symptom Checklist (PSC-17) is psychometric instrument used to assess the psychosomatic symptoms among the patients seeking health care at the health setting. Paired-sample t-test was used to assess how an BFT contributed to a reduction of psychosomatic symptomatology.
Measured: Two months or eight weeks of the follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start1 Mar 2020
- Primary completion30 Jul 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient EngagementStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rwanda
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francoise Uwizeye, University of Rwanda
- Investigators
- Francoise Uwizeye, Mr., Principal investigator, University of Rwanda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912414
- Sponsor's protocol ID
- 017/CMHS IRB/2020
- Status last verified
- Jun 2021
- First submitted
- 26 May 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As the data was collected from the patients and they were collected anonymously, the data may be shared with other researchers when request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Family Therapy (BFT) for the Treatment of Psychosomatic Symptoms in Rwanda
- ClinicalTrials.gov ID
- NCT04912414
- Acronym / sponsor ID
- 017/CMHS IRB/2020
- Conditions
- Patient Engagement
- Keywords
- Psychosomatic symptom, Anxiety, Brief Family Therapy, Session
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of RwandaUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 3 Jun 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.
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 body's immune system may be weakened by severe and/or 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brief Family Therapy (BFT) for the treatment of psychosomatic symptoms in Rwanda | Experimental | Behavioral: Brief Family Therapy (BFT)The participants from the control group were assigned to the Brief Family Therapy for reducing the medically unexplained symptoms. But the control group was not assigned to the intervention (BFT). |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being aged 18-59 years
- Being diagnosed Medically Unexplained Symptoms at least more than once with the similar symptoms.
- Being with psychosomatic at least more than 6 months
Key exclusion criteria (2 listed)
- Having no will to participate in the study;
- Not signing the informed consents to participate
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 |
|---|---|---|
| Brief Family Therapy (BFT)Patients transferred to the hospital for the treatment of psychosomatic symptoms was randomized (1:1) to receive either Brief Family Therapy (BFT) or a control treatment. Some participants randomized to the BFT arm receive a combination of chemotherapy and BFT and others receive only BFT. BFT comprises 10 sessions using a generic model of problem formation and resolution. This psychotherapy is useful for treating individual, couple, and family problems. Its broad applicability is based on its view that the client's complaint is the problem, not a symptom of something else BFT views behavior, especially a client's problematic behavior, as a function of interaction with other people. After randomization, all participants were asked to complete questionnaires about their psychosomatic symptoms and health at baseline, at the end of the intervention (at 4 months). | Behavioural | Brief Family Therapy (BFT) for the treatment of psychosomatic symptoms in Rwanda |
Primary outcome
Psychosomatic Symptom Checklist (PSC-17)
Time frame: Two months or eight weeks of the follow-up
Psychosomatic Symptom Checklist (PSC-17) is psychometric instrument used to assess the psychosomatic symptoms among the patients seeking health care at the health setting. Paired-sample t-test was used to assess how an BFT contributed to a reduction of psychosomatic symptomatology.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Individual participant dataSharing planned: No. As the data was collected from the patients and they were collected anonymously, the data may be shared with other researchers when request.
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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.
Francoise Uwizeye, Mr. principal investigator
University of Rwanda
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Family Therapy (BFT) in people with Patient Engagement, run by University of Rwanda at 2 sites in Rwanda.
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 3 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: finished, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Rwanda. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychosomatic Symptom Checklist (PSC-17) (time frame: Two months or eight weeks of the follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2021.