Condition category
Mental and Behavioural Disorders
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
13/11/2008
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 Judith van der Waerden

ORCID ID

Contact details

Maastricht University
Department of Health Education and Promotion
P.O. Box 616
Maastricht
6200 MD
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZonMw 4016.0004; NTR197

Study information

Scientific title

Effect-evaluation of the intervention "Being active without Worries": an intervention aimed at reducing depressive and stress symptomatology in adult low socioeconomic status (LSES) women from disfavourised communities

Acronym

Study hypothesis

1. Can a larger percentage of low socioeconomic status (LSES) women with depressive and/or stress related symptomatology be reached with an intervention when this contains an exercise component?
2. How effective is exercise only (B) compared to a control group (C) and does exercise plus psycho-education (BP) offer a surplus value above B?
3. How do LSES women appreciate this new intervention?

Ethics approval

Received from the local medical ethics committee

Study design

Randomised, single-blind, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Depressive and stress related symptomatology

Intervention

1. B-condition: the eight week intervention is offered with only the exercise component
2. BP-condition: the eight week intervention is offered with the exercise and psycho-education components
3. AC-condition: a control condition with postponed intervention for 3 months

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Depressive and stress related symptomatology, as measured by the CES-D, perceived stress scale, daily hassles scale. These measures will be administered two weeks before subjects start the course, 1 week after ending the course and next 6, 12 and 18 months after ending the course.

Secondary outcome measures

1. Social support
2. Mastery
3. Self-esteem
4. Self-efficacy
5. Assertiveness
6. Neighborhood perception

These will be measured two weeks before subjects start the course, 1 week after ending the course and next 6, 12 and 18 months after ending the course by means of questionnaires such as the Social Support List (SSL), personal mastery scale, the NPV, ALCOS and the SIG. Percentage of participating women will be determined by means of enrolment numbers for the course, satisfaction with the course will be determined by means of a questionnaire.

Overall trial start date

30/08/2005

Overall trial end date

31/08/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. The research population consists of adult women (20 - 55 years) with a LSES background
2. Furthermore, the women must have mild to moderate (sub-clinical) depressive symptomatology as measured with the Centre for Epidemiologic Studies Depression Scale (CES-D), or suffer from stress related complaints

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

240

Participant exclusion criteria

Because of the design of the intervention, participants are not allowed to have severe hearing problems or severe physical handicaps

Recruitment start date

30/08/2005

Recruitment end date

31/08/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Maastricht University
Maastricht
6200 MD
Netherlands

Sponsor information

Organisation

University Maastricht (UM) (The Netherlands)

Sponsor details

P.O. Box 616
Maastricht
6200 MD
Netherlands

Sponsor type

University/education

Website

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