Condition category
Mental and Behavioural Disorders
Date applied
13/07/2005
Date assigned
14/07/2005
Last edited
23/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.pstproject.nl

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 D’Zurilla
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

http://www.ggznederland.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

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

  1. 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.

  2. 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.

Additional files

Editorial Notes