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Brief Family Therapy (BFT) for the Treatment of Psychosomatic Symptoms in Rwanda

2 giugno 2021 aggiornato da: Francoise Uwizeye, University of Rwanda
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.

Panoramica dello studio

Stato

Completato

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

120

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Kigali, Ruanda
        • University of Rwanda
      • Kigali, Ruanda, P.O BOX: 4285 Kigali-Rwanda
        • University of Rwanda

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 59 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Having no will to participate in the study;
  • Not signing the informed consents to participate

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Brief Family Therapy (BFT) for the treatment of psychosomatic symptoms in Rwanda
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).
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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Psychosomatic Symptom Checklist (PSC-17)
Lasso di tempo: 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.
Two months or eight weeks of the follow-up

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Francoise Uwizeye, Mr., University of Rwanda

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 marzo 2020

Completamento primario (Effettivo)

30 luglio 2020

Completamento dello studio (Effettivo)

30 dicembre 2020

Date di iscrizione allo studio

Primo inviato

26 maggio 2021

Primo inviato che soddisfa i criteri di controllo qualità

2 giugno 2021

Primo Inserito (Effettivo)

3 giugno 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 giugno 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 giugno 2021

Ultimo verificato

1 giugno 2021

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 017/CMHS IRB/2020

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

As the data was collected from the patients and they were collected anonymously, the data may be shared with other researchers when request.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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