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
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
-
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.