Condition category
Mental and Behavioural Disorders
Date applied
17/05/2016
Date assigned
27/05/2016
Last edited
05/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Sexual Reproductive Health and Rights (SRHR) is a concept of human rights which applies to sexuality and reproduction. These rights extend to equal opportunities, rights and conditions of all people to have a safe and satisfying sexual life, and to be able to decide over their own bodies without coercion, violence or discrimination. In communities in post-conflict areas, such as Burundi, SRHR-related problems are particularly common. A huge amount of young girls are not married legally and are deprived of their rights to adequate family planning, as well as being victims of domestic violence. This study is looking at a sociotherapy program (a type of talking therapy which focuses on the environment and relationships with others) which has been designed to improve negative SRHR related consequences. The aim of this study is to evaluate whether of a sociotherapy program within a comprehensive SRHR program is an effective way of improving negative SRHR related consequences.

Who can participate?
Those aged 16 and over with SRHR-related problems.

What does the study involve?
Participating collines (villages) in Burundi are randomly allocated to one of two groups. Those in the first group attend a course of 15 group sessions of the sociotherapy programe over eight weeks. The sessions are run by trained facilitators and involve group discussions, role playing, and learning techniques to boost self-awareness and mutual understanding. Those in the second group continue as usual for the duration of the study, and are offered the sociotherapy programe after the study has been completed. At the start of the study and then again after eight and 15 weeks, participants in both groups have their mental health, social wellbeing and social skills measured using a series of questionnaires.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.

Where is the study run from?
The study is run from Healthnet TPO Burundi and takes place in different collines (villiages) in 7 communes spread over three provinces: Bujumbura Rural, Bubanza and Cibitoke (Burundi)

When is the study starting and how long is it expected to run for?
January 2016 to August 2016

Who is funding the study?
Dutch Embassy Burundi (Burundi)

Who is the main contact?
Professor Ivan Komproe

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ivan Komproe

ORCID ID

Contact details

Healthnet TPO
Lizzy Ansinghstraat 163
Amsterdam
1072 RG
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A Naturalistic Cluster Randomized Trial to study the efficacy of socio therapy group intervention in the SRHR program in Burundi

Acronym

Study hypothesis

The aim of this study is to establish the efficacy of the group interventions sociotherapy on negative SRHR related consequences of participants among the target population of the project in three provinces in Burundi. Specification of the domains of negative SRHR related consequences are:
1. Psychosocial, family and community functioning,
2. Physical health, well-being and general mental health and
3). Psychological and social processes and rebuilding social structures of local communities.

The two main hypotheses are:
1. The group interventions sociotherapy is effective to reduce physical and mental health complaints, distress and disability for SRHR related problems
2. The group interventions sociotherapy is effective to increase wellbeing and the individual and communal perspectives of (re)building social structures of communities

Ethics approval

Research Ethics Committee of the Lumière University in Bujumbura, 04/05/2016, ref: ULBU/Psy/03218/2016

Study design

Naturalistic cluster randomized trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

The negative consequences of violations of Sexual Reproductive Health and Rights (SRHR) on mental health, well-being and social functioning.

Intervention

The study will be conducted in different collines (villiages) in 7 communes spread over three provinces: Bujumbura Rural, Bubanza and Cibitoke. To avoid contamination of the intervention 15 collines (villiages) in these 7 communes are randomly allocated to the sociotherapy groups or control groups.

Intervention group: Participants attend a course of 15 group sessions of the Sociotherapy Intervention (ST) over a period of 8 weeks. These sessions are guided by trained facilitators and involve group discussions, role playing, practicing the Johari window, the square of autonomy and the four-circle model about culture in new environments technique, implementing insights about types of families, socialization, social systems, and social identity, listening and relaying the message, games and their importance, fundamental needs, emotions, the way to act in a new environment, communicating by signs (without words) and on prejudices.
These 15 sessions intervention consist of 6 phases with their own objectives to reach:
1. Security/peace
2. Confidence/trust
3. Mutual care and assistance
4. Mutual respect
5. New norms
6. Discussing the experienced change by reflecting the past and present situation.
All these objectives cover the following themes:
1. Having a desire/thirst to care for each other
2. Equality among the participants
3. Democracy during the sessions
4. Responsibility for the group process
5. Full participation
6. A focus on here, now and the future
7. Learning by doing to obtain and maintain change.

Control group: Participants are placed on a waiting list for the duration of the study. After the study they will be offered the opportunity to undergo the sociotherapeutic intervention.

Participants in both groups are followed up after 8 and 15 weeks

Intervention type

Phase

Drug names

Primary outcome measures

1. Mental Health is measured using the five-item version of the Mental Health Inventory (MHI) at baseline, 8 and 15 weeks
2. Social Wellbeing is measured using the Subjective Wellbeing scale (SW-4) at baseline, 8 and 15 weeks
3. Social functioning is measured using the RAND SF-12 at baseline, 8 and 15 weeks

Secondary outcome measures

1. General Health complaints are measured using the SCL-90-R (items 1, 4, 12, 27, 42, 52, 56) at baseline, 8 and 15 weeks
2. Societal changes are measured at baseline, 8 and 15 weeks using:
2.1. The Sense of community index
2.2. The Sense of coherence scale (SOC-13)

Overall trial start date

01/01/2016

Overall trial end date

20/08/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 16 years and older
2. Sexual Reproductive Health and Rights (SRHR) -related problems

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

Sociotherapeutic intervention will convene 15 groups of approximately 7 household couples per group (N=15) in 15 groups in selected collines (N=225 respondents) and takes place once a week for 15 consecutive weeks. The control group (under waiting list condition) will convene also 15 groups of 14 participants per group (N=15) in selected collines (N=225 respondents). Total for two Clusters N=450)

Participant exclusion criteria

Those who require immediate medical treatment.

Recruitment start date

25/03/2016

Recruitment end date

29/07/2016

Locations

Countries of recruitment

Burundi

Trial participating centre

Healthnet TPO Burundi
Avenue Muyinga N°21, Rohero I
Bujumbura
BP 1110
Burundi

Sponsor information

Organisation

Dutch Embassy Burundi

Sponsor details

Immeuble Old East
Place de l'independance
Bujumbura
-
Burundi

Sponsor type

Government

Website

http://burundi.nlambassade.org/

Funders

Funder type

Government

Funder name

Dutch Embassy Burundi

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

20/08/2017

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

05/10/2016: The reference number of the ethics approval has been added.