Condition category
Mental and Behavioural Disorders
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
03/09/2009
Prospective/Retrospective
Retrospectively 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

Prof Anthony Kendrick

ORCID ID

Contact details

Department of Primary Medical Care
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
+44 (0)23 80 241050
A.R.Kendrick@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 97/43/09

Study information

Scientific title

Acronym

Study hypothesis

The proposed study seeks to evaluate two treatments for anxiety and depression and reactions to life difficulties in general practice patients: a) generic CPN care, i.e.. non-specific support, and b) problem-solving therapy given by a specially trained CPN, each being compared with general practitioners' usual treatment as a control. The study has three specific aims: i) to determine the effectiveness of each of the two treatment in reducing symptoms and alleviating psychosocial problems, ii) to determine the cost-utility, cost-effectiveness, or cost-minimisation of the two treatments, depending on whether or not they prove effective, evaluating not only direct costs of treatment but also indirect costs, including time off work, and iii) to explore whether rapid self-complete tests might predict which patients could benefit from CPN treatment. The primary null hypothesis to be tested is that problem-solving by trained CPNs is no more effective for anxiety, depression and life difficulties than usual GP care. The second null hypothesis is that generic CPN care is no more effective than usual GP care, which would serve to confirm the findings of the one previous trial in this area.

Ethics approval

Added as of 27/07/2007: Ethical approval for the study was granted by the four local NHS research ethics committees covering the trusts’ catchment areas:
1. Southampton and South West Hampshire
2. East Dorset
3. North and Mid Hampshire
4. Isle of Wight, Portsmouth and South East Hampshire

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

Mental and behavioural disorders: Depression, anxiety, neuroses

Intervention

A randomised controlled trial with three arms: usual GP care, generic CPN care, and CPN problem-solving. A sample of 20 CPNs will be recruited to receive the problem-solving training, with 20 untrained CPNs from the same Trusts providing generic care.
Health technologies being assessed: Problem-solving includes 7 stages: (i) explanation of the treatment and its rationale, (ii) clarification and definition of the problems, (iii) choice of achievable goals, (iv) generation of alternative solutions, (v) selection of a preferred solution, (vi) clarification of the necessary steps to implement the solution, and (vii) evaluation of progress. Training will be in one-week blocks, of 10 CPNs at a time, followed by supervised treatment, specified in a detailed training manual, of at least 5 patients per nurse. Treatment will comprise an initial one-hour session and 3 or 4 half-hour follow-up sessions. Video-taped recordings will be made in each treatment session during the training period, for use in supervision sessions to give the nurses detailed feedback (in pairs) about their problem-solving skills.

Problem-solving treatment sessions will be audiotaped and a 1 in 10 sample checked for integrity of treatment. Nurses in the generic CPN care arm will be asked to get patients well as quickly as possible using the range of treatments they are experienced in giving, which will usually include non-specific counselling and support. All three groups of patients will be free to consult their GPs throughout the course of the study, and may be prescribed psychotropic drug treatment. Participating GPs will be asked not to refer patients in the routine GP care arm to a therapist during the study period, unless absolutely necessary.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The main outcome measure will be psychological symptoms measured using the revised CIS-R, analysed on an intention-to-treat basis. Social outcome will be measured using the modified Social Adjustment Scale and health-related quality of life using the Euroquol. Patient satisfaction will be measured using a specially designed self-report questionnaire.

The economic analysis (cost-utility, cost-effectiveness, or cost-minimisation depending on the outcomes found) will take into account the cost of CPN training, treatment and supervision, GP consultations, medication prescribed, the number of days off work for patients in paid employment, and other costs incurred by the patient or their family in attending treatment. Patients will be assessed at baseline, at 8 weeks (after the problem-solving therapy has been completed), and at 26 weeks. At baseline patients will be interviewed using the revised Clinical Interview Schedule (CIS-R) to provide total symptom scores and an ICD-10 diagnosis, and will also complete the General Health Questionnaire and Hospital Anxiety and Depression Scale (to explore the usefulness of these scales in predicting which patients benefit from treatment).

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/05/2000

Overall trial end date

30/04/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients aged 18 to 65 with a new episode of anxiety, depression or reaction to life difficulties, lasting at least four weeks.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Added as of 27/07/2007: 247

Participant exclusion criteria

Already receiving psychological treatment, severe mental illness, actively suicidal, severe substance misuse, housebound, illiterate, temporary residents.

Recruitment start date

01/05/2000

Recruitment end date

30/04/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Primary Medical Care
Southampton
SO16 5ST
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16153354

Publication citations

  1. Results

    Kendrick T, Simons L, Mynors-Wallis L, Gray A, Lathlean J, Pickering R, Harris S, Rivero-Arias O, Gerard K, Thompson C, A trial of problem-solving by community mental health nurses for anxiety, depression and life difficulties among general practice patients. The CPN-GP study., Health Technol Assess, 2005, 9, 37, 1-104, iii.

Additional files

Editorial Notes