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

NCT04912414 | Completed

• 1 other identifier: 017/CMHS IRB/2020
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Patient Engagement

Keywords

Psychosomatic symptom; Anxiety; Brief Family Therapy; Session

Outcome Measures

Primary Outcomes (1)

• 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.

  Two months or eight weeks of the follow-up

Study Arms (1)

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).

Behavioral: Brief Family Therapy (BFT)

Interventions

Brief Family Therapy (BFT) BEHAVIORAL

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).

Brief Family Therapy (BFT) for the treatment of psychosomatic symptoms in Rwanda

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Rwanda: lead

Study Sites (2)

University of Rwanda

Kigali, P.O BOX: 4285 Kigali-Rwanda, Rwanda

Location

University of Rwanda

Kigali, Rwanda

Location

MeSH Terms

Conditions

Patient Participation; Anxiety Disorders

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Mental Disorders

Study Officials

• Francoise Uwizeye, Mr.

  University of Rwanda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 3, 2021
• Study Start: March 1, 2020
• Primary Completion: July 30, 2020
• Study Completion: December 30, 2020
• Last Updated: June 3, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

RW (2)