Condition category
Mental and Behavioural Disorders
Date applied
22/12/2017
Date assigned
14/01/2018
Last edited
29/03/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Family members who care for patients with severe mental illness experience emotional distress and report a higher incidence of mental illness than those in the general population. They report feeling inadequately prepared to provide the necessary practical and emotional support for these patients. The MAT training, an Interaction-Skills Training program (IST) for caregivers, was developed to meet those needs. The aim of this study is to examine the impact of the training on caregivers’ sense of competence (self-efficacy) and burden.

Who can participate?
Family caregivers who care for patients with a severe mental illness

What does the study involve?
Family caregivers participated in the training over 10 weeks. Family caregivers’ burden and self-efficacy are assessed using questionnaires before and after the training and 3 months later.

What are the possible benefits and risks of participating?
The possible benefits of participation in the interaction-skills training are increased self-efficacy and reduced burden when caring for their family member with severe mental illness. No harm or discomfort is expected.

Where is the study run from?
1. Vincent van Gogh Instituut, Venlo (Netherlands)
2. Vincent van Gogh Instituut, Venray (Netherlands)
3. GGZ Friesland, Franeker (Netherlands)
4. GGZ Friesland, Heerenveen (Netherlands)
5. Propersona Lokatie Braamberg, Arnhem (Netherlands)

When is the study starting and how long is it expected to run for?
October 2014 to October 2016

Who is funding the study?
Inholland University of Applied Sciences (Netherlands)

Who is the main contact?
Yassamin Gharavi

Trial website

Contact information

Type

Scientific

Primary contact

Ms Yassamin Gharavi

ORCID ID

Contact details

Lange Leidsedwarsstraat
Amsterdam
1017NM
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Evidence of the effectivity of an interaction-skills training for reducing the burden of family caregivers of patients with severe mental illness: a pre-posttest design

Acronym

Study hypothesis

After following the IST program, family caregivers of patients with severe mental illness experience a greater sense of competence and a significant decrease in burden.

Ethics approval

Under Dutch law and legislation, no medical ethical approval was needed for this study, see CCMO. Only medical studies need to receive the approval of the Central Committee on Research Investigating Human Subjects (CCMO). This research does not fall under the scope of the Medical Research Involving Human Subjects Act (WMO). The following reference supports this point: ‘’Centrale Commissie Mensgebonden Onderzoek (CCMO), (2015)’’. After receiving verbal and written information on the study, all participants signed for informed consent.

Study design

Pre-posttest design

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Quality of life

Patient information sheet

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

Condition

Clinical health psychology, severe mental illness

Intervention

The interaction skills training (IST) program was offered at three mental health institutions in various parts of the Netherlands. Within these three hospitals, there was an open registration for family members to participate in the training. The training was announced through the mental health professionals, local media, or a brochure. Family members were recruited through their registered patients, through local media, or a brochure. One hundred family caregivers recruited from three mental health institutions participated in the training. The duration of the training program was 10 weeks.

The trialists examined the effect of the program on self-efficacy and burden, which were measured on three occasions: at T0 (baseline), T1 (after the training/at 8 weeks) and T2 (3 months after termination of the training). The third measurement also included a brief evaluation of the caregivers’ perspective on the training. Burden was assessed using the Involvement Evaluation Questionnaire, and self-efficacy using the Self-Efficacy Questionnaire. Analysis of variance with repeated measures was used to investigate whether participation in the training changed the level of family caregivers’ burden and self-efficacy. Pearson’s correlation was used to examine the relationships between self-efficacy and burden.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Measured at T0 (baseline), T1 (after the training/at 8 weeks) and T2 (3 months after termination of the training):
1. Burden assessed using the Involvement Evaluation Questionnaire
2. Self-efficacy assessed using the Self-Efficacy Questionnaire

Secondary outcome measures

Appreciation of the components of the training, measured with a short survey at T2 (3 months after termination of the training)

Overall trial start date

13/10/2014

Overall trial end date

25/10/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Being a family member of, and caring for, a patient with a severe mental illness, defined as not being free of symptoms, having had the mental illness in the long term (>2 years), and having serious limitations in personal and social functioning

Participant type

Carer

Age group

All

Gender

Both

Target number of participants

100

Participant exclusion criteria

Being a family member and caring for a patient who does not meet the specific criteria for a severe mental illness

Recruitment start date

01/02/2015

Recruitment end date

01/03/2016

Locations

Countries of recruitment

Netherlands

Trial participating centre

Vincent van Gogh Instituut
Tegelseweg 210
Venlo
5912BL
Netherlands

Trial participating centre

Vincent van Gogh Instituut
Stationsweg 46
Venray
5803 AC
Netherlands

Trial participating centre

GGZ Friesland
Burgemeester J. Dijkstraweg 6
Franeker
8801 PG
Netherlands

Trial participating centre

GGZ Friesland
Kastanjelaan 1
Heerenveen
8441 NC
Netherlands

Trial participating centre

Propersona Lokatie Braamberg
Wagnerlaan 2
Arnhem
6815 AG
Netherlands

Sponsor information

Organisation

Inholland University of Applied Sciences / Department of Nursing

Sponsor details

De Boelelaan 1109
Amsterdam
1081 HV
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Inholland University of Applied Sciences

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The manuscript has been submitted to BMC Psychiatry.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Berno van Meijel (Berno.vanMeijel@Inholland.nl). Type of data: SPSS dataset with background characteristics of the participants and data on experienced burden (measured with the Involvement Evaluation Questionnaire / IEQ) and perceived self-efficacy (measured with the Self-Efficacy Questionnaire / SEQ) of family members of patients with severe mental illness. Complete data on IEQ and SEQ are available from 75 patients at three measurements: at T0 (before the start of the training program), at T1 (after termination of the training / 8 weeks) and at follow-up (3 months after termination of the training program). Data will be available from 01/01/2018 indefinitely. Data are made available for collaborative research with the initial researchers, based on an approved research protocol by participating research organizations and relevant ethical committees. Informed consent was obtained from all participants in this study. Data in this dataset are anonymized.

Intention to publish date

27/01/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29587690

Publication citations

Additional files

Editorial Notes

29/03/2018: Publication reference added.