Contact information
Type
Scientific
Primary contact
Dr P. van Oppen
ORCID ID
Contact details
van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 8395
pvanoppen@ggzba.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
42.00.0001; NTR607
Study information
Scientific title
Acronym
PST
Study hypothesis
There is a need for assistance by primary care mental health workers in general practice in the Netherlands. General Practitioners (GPs) experience an overload of frequent attenders suffering from (co-morbid) psychological problems. For most GPs these problems are complicated to recognise and to refer. PST is a brief and practical skill-building psychological treatment. The treatment has a strict protocol and is based on the principles of cognitive behavioural therapy. PST delivered by nurses seems to be an effective treatment for patients with psychological problems in primary care. This treatment increases the patients skill of structured problem solving and gives back a sense of control. However, research outcomes differ and no systematic review is available. This protocol describes a randomised clinical trial on the effectiveness of PST delivered by nurses for patients in general practice.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
Psychological problems
Intervention
PST versus care as usual.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Reduction of symptoms, measured using the Hospital Anxiety and Depression Scale (HADS) to monitor symptom levels of anxiety and depression.
Secondary outcome measures
1. Social problem-solving skills, measured using a questionnaire designed by DZurilla
2. Psychological and physical well-being using the 36-item short form health survey (SF-36)
3. Social support, using the Social Support Inventory
4. Coping-styles by the VOMS (Vragenlijst over Omgaan met Situaties) is the Dutch adaption of the ways of coping questionnaire (WAYS) which is based on the transactional coping theory of Lazarus and Folkman
5. Rumination: actual scientific reports suggest rumination as a significant, and probable prognostic, factor for depression. The ruminative response scale (RRS) wil be used to measure this.
6. Problem evaluation
7. Health care utilisation. We used the Trimbos/iMTA questionnaire for costs associated with psychiatric illness (Tic-P) to measure the amount health care patients consume and to register sick days from work. Furthermore, the EQ-5D was used.
Overall trial start date
01/11/2002
Overall trial end date
01/11/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Patients of 18 years and older, who present psychological problems and are frequent attenders of general practice are recruited by the research-assistant.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
160
Participant exclusion criteria
1. Patients who are treated in last year in the GGz, for example with cognitive behaviour therapy
2. Patients who suffer from a serious medical sickness, psychotic impairment, primarily organic-mental impairment or serious individuality problems
3. Patients who are multiple visitors of the general practitioner because of chronic disease or hypochondria
4. Patients who are indicated for anxiolytic or antidepressant treatment, or patients who used these drugs less than 12 weeks ago, or those without constant treatment dose in the following 10 weeks
5. Patients with serious addiction problems
6. Patients who are suicidal
7. Patients who are not able to fill in the questionnaire (General Health Questionnaire [GHQ])
8. Patients with insufficient knowledge of the Dutch language
Recruitment start date
01/11/2002
Recruitment end date
01/11/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
Sponsor information
Organisation
Ministry of Mental Health Care (Geestelijke Gezondheidszorg [GGZ]) (The Netherlands)
Sponsor details
van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
Sponsor type
Government
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
1. 2005 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16221299
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23052105
Publication citations
-
Protocol
Schreuders B, van Oppen P, van Marwijk HW, Smit JH, Stalman WA, Frequent attenders in general practice: problem solving treatment provided by nurses [ISRCTN51021015]., BMC Fam Pract, 2005, 6, 42, doi: 10.1186/1471-2296-6-42.
-
Results
Bosmans JE, Schreuders B, van Marwijk HW, Smit JH, van Oppen P, van Tulder MW, Cost-effectiveness of problem-solving treatment in comparison with usual care for primary care patients with mental health problems: a randomized trial., BMC Fam Pract, 2012, 13, 98, doi: 10.1186/1471-2296-13-98.