Problem Solving Treatment (PST) Project

ISRCTN	ISRCTN51021015
DOI	https://doi.org/10.1186/ISRCTN51021015
Protocol serial number	42.00.0001; NTR607
Sponsor	Ministry of Mental Health Care (Geestelijke Gezondheidszorg [GGZ]) (The Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

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 of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	PST
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Psychological problems
Intervention	PST versus care as usual.
Intervention type	Other
Primary outcome measure(s)	Reduction of symptoms, measured using the Hospital Anxiety and Depression Scale (HADS) to monitor symptom levels of anxiety and depression.
Key secondary outcome measure(s)	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.
Completion date	01/11/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	160
Key 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.
Key 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
Date of first enrolment	01/11/2002
Date of final enrolment	01/11/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

van der Boechorststraat 7

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	10/10/2012		Yes	No
Protocol article	protocol	12/10/2005		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes