| - candidate number | 2301 |
| - NTR Number | NTR799 |
| - ISRCTN | ISRCTN17831610 |
| - Date ISRCTN created | 28-dec-2006 |
| - date ISRCTN requested | 18-dec-2006 |
| - Date Registered NTR | 27-okt-2006 |
| - Secondary IDs | N/A |
| - Public Title | Stepped care in depression and anxiety: from primary to secondary care. |
| - Scientific Title | Stepped care in depression and anxiety: from primary to secondary care. |
| - ACRONYM | SAD |
| - hypothesis | A stepped care program in primary care for patients with depressive and/or anxiety disorders is more effective than care as usual. |
| - Healt Condition(s) or Problem(s) studied | Depressive disorders, Anxiety disorders |
| - Inclusion criteria | They are recruited through screening (all patients who visited their GP). They have to meet the following criteria: 1. Between 18-65 years; 2. A 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. |
| - Exclusion criteria | Patients are excluded if they: 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. |
| - mec approval received | no |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 1-jan-2007 |
| - planned closingdate | 1-sep-2010 |
| - Target number of participants | 200 |
| - Interventions | 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 characterized 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. |
| - Primary outcome | Speed of recovery in terms of symptom reduction (QIDS for depression, and the HADS-A for anxiety) at baseline and after 8, 16 and 24 weeks. |
| - Secondary outcome | At baseline and after 8, 16 and 24 weeks: 1. DSM diagnosis (CIDI); 2. Quality of life (SF36 and Euroqol); 3. The use of health care services (TIC-P); 4. The use of medication (TIC-P); 5. Productivity losses (TIC-P); 6. Satisfaction with delivered care / continuity of care (Quote). |
| - Timepoints | |
| - Trial web site | N/A |
| - status | planned |
| - CONTACT FOR PUBLIC QUERIES | MSc. Laura Kool |
| - CONTACT for SCIENTIFIC QUERIES | PhD. Annemieke Straten, van |
| - Sponsor/Initiator | VU University Medical Center, EMGO-Institute |
| - Funding (Source(s) of Monetary or Material Support) | ZON-MW, The Netherlands Organization for Health Research and Development |
| - Publications | N/A |
| - Brief summary | Primary care patients with depressive and / or anxiety disorders are randomly assigned to stepped care or care as usual. Stepped care consists of 4 interventions of increasing intensity: (1) watchful waiting (2) bibliotherapy (3) problem solving therapy (4) medication and / or psychotherapy in mental health care. Patients will be monitored at baseline and after 8, 16 and 24 weeks on primary outcomes (symptoms of depression and anxiety) and secondary outcomes (quality of life, use of health care services, medication use, productivity loss, satisfaction with care / continuity of care. |
| - Main changes (audit trail) | |
| - RECORD | 27-okt-2006 - 29-dec-2006 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl