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
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