Randomised controlled trial of a brief, activating treatment by social workers and usual general practitioner care for patients with minor mental disorders leading to sickness absence
| ISRCTN | ISRCTN10342533 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10342533 |
| Secondary identifying numbers | 2200.0100 |
- Submission date
- 30/06/2005
- Registration date
- 25/08/2005
- Last edited
- 24/09/2007
- 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 Peter Verhaak
Scientific
Scientific
PO Box 1568
Utrecht
3513 CR
Netherlands
| Phone | +31 (0)30 272 9735 |
|---|---|
| p.verhaak@nivel.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Is a brief, activating treatment by social workers more successful in reducing long term absenteeism and in increasing patient well-being than General Practitioners' (GPs') usual care in patients with minor mental disorders ((e.g. mild depression, generalised anxiety disorder, adjustment disorder) who are on sick leave? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Minor mental disorders |
| Intervention | Usual GP care or five sessions in ten weeks with a social worker trained in the technique, including homework assignments and a focus on early work resumption. The main aims of the experimental treatment were: 1. To focus on the most recent and actual problems 2. To regain functionality and control 3. To resume work as early as possible |
| Intervention type | Other |
| Primary outcome measure | The groups did not differ at baseline, nor after three, six or 18 months with respect to levels of depression, anxiety, somatisation, distress, functional status or sick leave duration. In both groups, well-being improved significantly in the first months after baseline, regardless of treatment. |
| Secondary outcome measures | Patients who received the brief activating treatment by social workers reported higher satisfaction than patients who received GPs' usual care. |
| Overall study start date | 05/03/2001 |
| Completion date | 31/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 370 primary care patients |
| Key inclusion criteria | Included were primary care patients who: 1. Were suffering from minor mental disorder(s) according to GP and patient 2. Had paid employment 3. Were on sick leave or planning to be directly after visit to GP, but had not been on sick leave for longer than three months 4. Were aged 18 to 60 years 5. Were Dutch speaking |
| Key exclusion criteria | Excluded were patients who were already receiving psychotherapy, or who, according to the Composite International Diagnostic Interview (CIDI), had a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of: 1. Moderately severe or severe mood disorder 2. Agoraphobia 3. Panic disorder 4. Social phobia |
| Date of first enrolment | 05/03/2001 |
| Date of final enrolment | 31/10/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
PO Box 1568
Utrecht
3513 CR
Netherlands
3513 CR
Netherlands
Sponsor information
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Research organisation
Research organisation
Laan van Nieuw Oost Indië 334
PO Box 93245
The Hague
2509 AE
Netherlands
| Phone | +31 (0)70 349 5111 |
|---|---|
| info@zonmw.nl | |
| Website | http://www.zonmw.nl |
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) (ref: 2200.0100)
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 | 01/04/2007 | Yes | No |
