Effect-evaluation of the intervention "Being active without Worries"
| ISRCTN | ISRCTN42389025 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42389025 |
| Secondary identifying numbers | ZonMw 4016.0004; NTR197 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 13/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Judith van der Waerden
Scientific
Scientific
Maastricht University
Department of Health Education and Promotion
P.O. Box 616
Maastricht
6200 MD
Netherlands
Study information
| Study design | Randomised, single-blind, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| 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 |
| Study objectives | 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(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 30/08/2005 |
| Completion date | 31/08/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 240 |
| Key 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 |
| Key exclusion criteria | Because of the design of the intervention, participants are not allowed to have severe hearing problems or severe physical handicaps |
| Date of first enrolment | 30/08/2005 |
| Date of final enrolment | 31/08/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Maastricht University
Maastricht
6200 MD
Netherlands
6200 MD
Netherlands
Sponsor information
University Maastricht (UM) (The Netherlands)
University/education
University/education
P.O. Box 616
Maastricht
6200 MD
Netherlands
"ROR" |
https://ror.org/02jz4aj89 |
|---|
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
