Stepped care in Depression and Anxiety: from primary to secondary care

ISRCTN	ISRCTN17831610
DOI	https://doi.org/10.1186/ISRCTN17831610
Protocol serial number	N/A
Sponsor	VU University Medical Center (The Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

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

VU University Medical Center, FPP
Department of Clinical Psychology
Van der Boechorststraat 1
Amsterdam
1081 BT
Netherlands

Phone	+31 (0) 20 598 2544
Email	lm.kool@psy.vu.nl

Study information

Primary study design	Interventional
Study design	Randomised, controlled, parallel group multicentre trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	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)
Completion date	01/09/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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