Contact information
Type
Scientific
Primary contact
Ms Laura Kool
ORCID ID
Contact details
VU University Medical Center
FPP
Department of Clinical Psychology
Van der Boechorststraat 1
Amsterdam
1081 BT
Netherlands
+31 (0) 20 598 2544
lm.kool@psy.vu.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
SAD
Study hypothesis
A stepped care program in primary care for patients with depressive and/or anxiety disorders is more effective than care as usual.
Ethics approval
Approval received from the Medical Ethics Review Committee of the VU Medical Centre on the 1st February 2007 (ref: 06/248).
Study design
Randomised, controlled, parallel group multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/01/2007
Overall trial end date
01/09/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
200
Participant 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
Recruitment start date
01/01/2007
Recruitment end date
01/09/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
VU University Medical Center, FPP
Amsterdam
1081 BT
Netherlands
Sponsor information
Organisation
VU University Medical Center (The Netherlands)
Sponsor details
EMGO Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 8180
emgo@vumc.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21736720
Publication citations
-
Results
Seekles W, van Straten A, Beekman A, van Marwijk H, Cuijpers P, Stepped care treatment for depression and anxiety in primary care. a randomized controlled trial., Trials, 2011, 12, 171, doi: 10.1186/1745-6215-12-171.