Stepped care in Depression and Anxiety: from primary to secondary care
| ISRCTN | ISRCTN17831610 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17831610 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/12/2006
- Registration date
- 28/12/2006
- Last edited
- 22/11/2011
- 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
Ms Laura Kool
Scientific
Scientific
VU University Medical Center, FPP
Department of Clinical Psychology
Van der Boechorststraat 1
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0) 20 598 2544 |
|---|---|
| lm.kool@psy.vu.nl |
Study information
| Study design | Randomised, controlled, parallel group multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | SAD |
| Study objectives | A stepped care program in primary care for patients with depressive and/or anxiety disorders is more effective than care as usual. |
| Ethics approval(s) | Approval received from the Medical Ethics Review Committee of the VU Medical Centre on the 1st February 2007 (ref: 06/248). |
| Health condition(s) or problem(s) studied | Depressive disorders, Anxiety disorders |
| Intervention | In the current study a stepped care program will be developed for primary care patients with anxiety and/or depression. A stepped care program is characterised by different steps of treatment that are arranged in order of increasing intensity. After each step, the patient will be monitored, to determine if symptoms have been sufficiently reduced. The program consists of evidence based interventions: 1. Watchful waiting 2. Bibliotherapy 3. Problem solving treatment 4. Medication and/or an evidence based treatment in specialised mental health care The control condition is care as usual. |
| Intervention type | Other |
| Primary outcome measure | Speed of recovery in terms of symptom reduction (Quick Inventory of Depressive Symptomatology [QIDS] for depression, and the Hospital Anxiety and Depression Scale [HADS-A] for anxiety) at baseline and after eight, 16 and 24 weeks. |
| Secondary outcome measures | At baseline and after eight, 16 and 24 weeks: 1. DSM diagnosis (Composite International Diagnostic Interview [CIDI]) 2. Quality of life (Short Form health survey [SF36] and Euroqol questionnaire) 3. The use of health care services (Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness [TIC-P]) 4. The use of medication (TIC-P) 5. Productivity losses (TIC-P) 6. Satisfaction with delivered care/continuity of care (Quote) |
| Overall study start date | 01/01/2007 |
| Completion date | 01/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 200 |
| Key inclusion criteria | They are recruited through screening (all patients who visited their General Practitioner [GP]). They have to meet the following criteria: 1. Between 18 to 65 years 2. A Diagnostic and Statistical Manual of mental disorders (DSM) diagnosis of minor depression, major depression, dysthymia, panic disorder (with or without agoraphobia), generalised anxiety disorder, or social phobia. Patients with minor anxiety (not fulfilling any DSM criteria of an anxiety disorder) will also be included |
| Key exclusion criteria | 1. Have psychotic or bipolar symptoms 2. Have a high suicide risk 3. Are currently under treatment or received treatment for depression/anxiety in the past twelve months 4. Cannot read or write Dutch sufficiently enough to complete the questionnaires |
| Date of first enrolment | 01/01/2007 |
| Date of final enrolment | 01/09/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU University Medical Center, FPP
Amsterdam
1081 BT
Netherlands
1081 BT
Netherlands
Sponsor information
VU University Medical Center (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
EMGO Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)20 444 8180 |
|---|---|
| emgo@vumc.nl | |
| Website | http://www.vumc.nl/ |
"ROR" |
https://ror.org/00q6h8f30 |
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 07/07/2011 | Yes | No |
