Effectiveness of a Minimal Intervention Strategy for patients with common mental disorders on sick leave: a pragmatic randomized controlled trial in General Practice
| ISRCTN | ISRCTN43779641 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43779641 |
| Secondary identifying numbers | 4200.0003 |
- Submission date
- 17/01/2005
- Registration date
- 19/04/2005
- Last edited
- 15/04/2010
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Berend Terluin
Scientific
Scientific
van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)20 444 93 68 |
|---|---|
| b.terluin@vumc.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Scientific title | |
| Study acronym | MISS |
| Study objectives | The objective of this study is to assess the effectiveness of the minimal intervention package (MISS) for distressed patients in general practice. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Common mental disorders and sick leave |
| Intervention | This study is a pragmatic randomized controlled trial in general practice. Forty GPs will be randomized to the intervention group or the usual care group. The GPs in the intervention group will receive training in the implementation of the MISS intervention. This intervention package has been developed to assist the GPs in dealing with distressed patients. Within the limits of three 10-minute consultations, the GP should be able to: 1. Detect significant depression and anxiety, and to deal with it specifically 2. Educate the patient about distress and the best ways to cope with the situation 3. Advise the patient to see an occupational physician 4. Evaluate any progress four weeks later, and refer the patient to a psychological professional if no progress has been made |
| Intervention type | Other |
| Primary outcome measure | Duration of occupational disability |
| Secondary outcome measures | Social functioning/quality of life, application for disability benefit after one year of sick leave (WAO), unemployment, psychological symptoms, and utilization of medical services. The outcomes will be assessed after 2, 6 and 12 months of follow-up. |
| Overall study start date | 01/09/2003 |
| Completion date | 31/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 415 |
| Key inclusion criteria | Patients (20-60 years old) who visited their GP, having distress complaints, paid work and sick leave no longer than three months |
| Key exclusion criteria | Severe psychiatric disorders (mania or psychosis), patients who were terminally ill or who couldn't speak Dutch properly. |
| Date of first enrolment | 01/09/2003 |
| Date of final enrolment | 31/01/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
1081 BT
Netherlands
Sponsor information
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Research organisation
Research organisation
Laan van Nieuw Oost Indië 334
P.O. Box 93245
The Hague
2509 AE
Netherlands
| Phone | +31 (0)70 349 5111 |
|---|---|
| info@zonmw.nl | |
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 04/05/2006 | Yes | No | |
| Results article | results | 01/06/2007 | Yes | No | |
| Results article | results | 01/02/2010 | Yes | No |
