ISRCTN ISRCTN51021015
DOI https://doi.org/10.1186/ISRCTN51021015
Secondary identifying numbers 42.00.0001; NTR607
Submission date
13/07/2005
Registration date
14/07/2005
Last edited
23/05/2013
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

Not provided at time of registration

Study website

Contact information

Dr P. van Oppen
Scientific

van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Phone +31 (0)20 444 8395
Email pvanoppen@ggzba.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Scientific title
Study acronymPST
Study hypothesisThere 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(s)Ethics approval received from the local medical ethics committee
ConditionPsychological problems
InterventionPST versus care as usual.
Intervention typeOther
Primary outcome measureReduction of symptoms, measured using the Hospital Anxiety and Depression Scale (HADS) to monitor symptom levels of anxiety and depression.
Secondary outcome measures1. 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 study start date01/11/2002
Overall study end date01/11/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants160
Participant inclusion criteriaPatients of 18 years and older, who present psychological problems and are frequent attenders of general practice are recruited by the research-assistant.
Participant exclusion criteria1. 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 date01/11/2002
Recruitment end date01/11/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Sponsor information

Ministry of Mental Health Care (Geestelijke Gezondheidszorg [GGZ]) (The Netherlands)
Government

van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Website http://www.ggznederland.nl/

Funders

Funder type

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 12/10/2005 Yes No
Results article results 10/10/2012 Yes No