Condition category
Mental and Behavioural Disorders
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
14/02/2008
Prospective/Retrospective
Retrospectively 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 S. Onrunst

ORCID ID

Contact details

Trimbos Institute/Netherlands Institute of Mental Health and Addiction
P.O.Box 725
Utrecht
3500 AS
Netherlands
+31 (0)30 2971100
sonrust@trimbos.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZON-MW 63-224

Study information

Scientific title

Acronym

Study hypothesis

Contact with fellow-sufferers, as offered by visiting services to widowed persons with little social support, would show superior effects in improving mental health, quality of life and reducing financial costs to society, compared by a control condition

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

International

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Psychological problems

Intervention

Experimental: visiting service.In the visiting service, recently widowed persons are offered to hold supportive one-to-one talks with trained fellow-sufferers. The objective is to provide social support. The volunteers make maximally 10 home visits, spread out over a one-year period.
Control condition: respondents in the control condition are offered a brochure about the prevention of depression. These respondents are free to seek help elsewhere on their own initiative.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Mental health
2. Cost-effectiveness

Secondary outcome measures

1. Quality of life
2. Grief process
3. Mastery of condition
4. Loneliness

Overall trial start date

01/11/2002

Overall trial end date

01/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Widow/widower
2. Aged 55 years or older
3. Has lost his/her partner through death 6-12 months earlier
4. Feels lonely according to the 'Lonelisness Scale'
5. No mental disorder according to the MINI

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

350

Participant exclusion criteria

When not met the five inclusion criteria mentioned above, people are excluded.

Recruitment start date

01/11/2002

Recruitment end date

01/05/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Trimbos Institute/Netherlands Institute of Mental Health and Addiction
Utrecht
3500 AS
Netherlands

Sponsor information

Organisation

Trimbos Institute (The Netherlands)

Sponsor details

Da Costakade 45 Postbus 725
Utrecht
3500 AS
Netherlands

Sponsor type

Charity

Website

Funders

Funder type

Research organisation

Funder name

ZON-MW, The Netherlands Organization for Health Research and Development

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