Condition category
Mental and Behavioural Disorders
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
22/11/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.vumc.nl/

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

  1. 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.

Additional files

Editorial Notes