Condition category
Mental and Behavioural Disorders
Date applied
30/05/2007
Date assigned
30/05/2007
Last edited
22/08/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ernst Bohlmeijer

ORCID ID

Contact details

Trimbos-Instituut
P.O. Box 725
Utrecht
3500 AS
Netherlands
+31 (0)30 2971100
ebohlmeijer@trimbos.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The new preventive intervention will lead to a significant decrease in psychological problems and perceived stress, an improvement in the quality of life of the informal care-givers as compared with a waiting list control group.

Ethics approval

Ethics approval received from the local ethics committee (METIGG kamer Noord) on the 23rd January 2007.

Study design

Randomised, multicentre, placebo controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Informal care-givers, prevention, depression, burnout, stress

Intervention

The Informal care-givers in Balance course consists of eight two-hour sessions and is designed for adult children who provide structural care for a parent in need of care and are under high perceived stress as a result. At the first three sessions, the participants learn to interview their own parent according to the life review method. Starting at the fourth session of the course, the perspective shifts to the informal care-givers’ own life. The informal care-givers focus on the meaning and effects, especially undesirable ones, of the informal care on their lives and on the balance they would like to establish in their lives in accordance with the life review method. The possibilities are addressed for introducing a better balance.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Depressive symptoms
2. Perceived stress
3. Quality of life

Outcomes will be measured at:
T0: one week before start of intervention
T1: after three months (directly after intervention)
T2: after six month (three months after intervention)

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/09/2007

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Adults above the age of eighteen who provide informal care for a parent and feel they are under stress as a result.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

200

Participant exclusion criteria

1. The parent of the informal care-provider is no longer able to take part in the life review, e.g. because of having severe dementia
2. The health situation of the parent or informal caregiver requires acute assistance

Recruitment start date

01/09/2007

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Trimbos-Instituut
Utrecht
3500 AS
Netherlands

Sponsor information

Organisation

Trimbos-Institute - Netherlands Institute of Mental Health and Addiction (The Netherlands)

Sponsor details

P.O. Box 725
Utrecht
3500 AS
Netherlands
+31 (0)30 2971100
info@trimbos.nl

Sponsor type

Research organisation

Website

http://www.trimbos.nl/default37.html

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes