|- candidate number||0|
|- NTR Number||NTR197|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||26-aug-2005|
|- Secondary IDs||ZonMw 4016.0004 |
|- Public Title||Effect-evaluation of the intervention “Being active without Worries”.|
|- Scientific Title||Effect-evaluation of the intervention “Being active without Worries”, an intervention aimed at reducing depressive and stress symptomatology in adult low- SES women from disfavourized communities.|
|- hypothesis||1. Can a larger percentage of Low SES 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?|
|- Healt Condition(s) or Problem(s) studied||Depressive and stress related symptomatology|
|- Inclusion criteria||The research population consists of adult women (20-55 yrs) with a low- SES background. Furthermore, the women must have mild to moderate (sub clinical) depressive symptomatology as measured with the CES- D, or suffer from stress related complaints.|
|- Exclusion criteria||Because of the design of the intervention, participants are not allowed to have severe hearing problems or severe physical handicaps.|
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||30-aug-2005|
|- planned closingdate||31-aug-2009|
|- Target number of participants||240|
|- Interventions||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. A C-condition, a control condition with postponed intervention for 3 months.
(see also summary for explanation).|
|- Primary outcome||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||Secondary outcomes are social support, mastery, self- esteem, self- efficacy, assertiveness and 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 as the SSL, personal mastery scale, the NPV, ALCOS and the SIG.
Percentage of participating women will be determined by means of enrollment numbers for the course, satisfaction with the course will be determined by means of a questionnaire.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Judith Waerden, van der|
|- CONTACT for SCIENTIFIC QUERIES|| Judith Waerden, van der|
|- Sponsor/Initiator ||University Maastricht (UM)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Social economic characteristics explain for an important part mental health problems. Individuals with a depression have often experienced one or more stressful life events in the year preceding their depression. The meaning attributed to these stressful experiences is an important explanatory factor in the onset of depression. Women with low social economic status (LSES) in disadvantaged neighborhoods are often charged with multiple stressors (low education, low income, poor labor conditions, unemployment) and are a vulnerable group for the onset of mental health problems such as depression and stress.
Nationally, the “coping with depression” course has been developed in different versions for different target groups. However, research shows that the course is not easily accessible for LSES groups. There is considerably more drop- out amongst LSES participants, the course level and homework are considered to be too difficult, and the enrollment method using ads is less suitable. The course has been adapted to the target population by, amongst others, adding an exercise component. Exercise has a beneficial anti- depressant effect.
The goal of the project is to carry out an effect evaluation of the course “being active without worries”, in order to investigate if the course can prevent depressive and stress related symptomatology in LSES women.|
|- Main changes (audit trail)|
|- RECORD||6-sep-2005 - 18-dec-2006|