Plain English Summary
Background and study aims
The Nottingham study of neurotic disorder (NSND) was set up in 1983 to look at both the short and long term outcome of common anxiety and depressive disorders. In particular, it examined whether separately classifying individual neurotic disorders (for example into depression, bipolar affective disorder, social anxiety disorder) was actually helpful for either science or in treating sufferers of these conditions. Many patients were found to be have a mixed anxiety/depression disorder and could be considered to suffer from a general neurotic syndrome. The study investigated whether diagnosing a patient as suffering from a general neurotic disorder rather than making a conventional clinical diagnosis made any difference to predicting how the patient responded to treatment, or whether some modes of treatment (different treatments) were more successful than others. Data for the study has been collected on 9 further occasions since 1983, the last time being 12 years after the start of the trial. We are now repeating the assessments after 30 years as neurotic disorders can have some very long-term effects.
Who can participate?
Adults on no active treatment at the start of the study and diagnosed with generalized anxiety disorder, neurotic depression or panic disorder.
What does the study involve?
Participants are asked to attend a single follow up interview lasting about 85 minutes. The questions cover psychiatric diagnosis and symptoms, personality and social functioning, and service contacts. Written permission to access the patients' general practice medical notes is also requested at the beginning of the interview.
What are the possible benefits and risks of participating?
The patients have been followed up many times previously and have been seen by the same investigator, Dr Helen Tyrer, on the last occasion. Many look forward to the updated assessment and all of those approached at 12 years who gave consent to be seen at 30 years have been noted. At 12 years we had very positive views about the study and its progress. 4 patients who said they did not want to be followed up will not be seen at 30 years. We do not think there are any particular risks of the study all data to be obtained have been asked about before. We will also be carrying out an interview to find out what major events have occurred over the past 30 years. This will include finding out how much each event has affected their mental health, and how it came about. This is part of a formal investigation into nidotherapy, the changing of the environment to better fit a person and their surroundings.
Where is the study run from?
Imperial College London (UK)
When is the study starting and how long is it expected to run for?
January 2014 to June 2017
Who is funding the study?
1. Department of Health Offender Health (UK)
2. Nicola Pigott Memorial Fund (UK)
Who is the main contact?
Professor Peter Tyrer
p.tyrer@imperial.ac.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
16681
Study information
Scientific title
30-year follow-up of personality and clinical status of patients with anxiety and depression in the Nottingham Study of Neurotic Disorder: an observational cohort study following a randomised trial
Acronym
Nott30
Study hypothesis
This is a long-term follow-up of patients recruited to a randomised controlled trial of cognitive behaviour therapy, drug therapy and self-help in 1988, and although this has now become a cohort study in the first two years of the trial the mode of therapy was kept the same as that randomised.
More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=16681
Original trial can be found at: http://www.ncbi.nlm.nih.gov/pubmed/2899234
Ethics approval
12/EM/0331; First MREC approval date 21/11/2012
Study design
Randomised; Observational; Design type: Cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Mental Health; Subtopic: Anxiety, Depression; Disease: Depression, Anxiety
Intervention
In the original trial the patients were randomised to one of three drug treatments (diazepam, dothiepin and placebo), cognitive behaviour therapy or self-help, and most of the patients (70%) maintained this allocation for the first 2 years of this study.
1. Cognitive behaviour therapy: 3-6 sessions of treatment given by a trained nurse under supervision from an established therapist
2. Diazepam: matching tablets of diazepam (5-30 mg daily) with ascending dosage to preferred maximum over 6 weeks then reduction to zero by 10 weeks
3. Dothiepin, matching tablets of dothiepin (25-150 mg daily) with ascending dosage to preferred maximum over 6 weeks then reduction to zero by 10 weeks
4. Placebo: matching placebo medication
5. Self-help: relaxation tape and self-help instructions
Follow Up Length: 360 month(s); Study Entry : Registration only
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Comprehensive Psychopathological Rating Scale; Timepoint(s): baseline, 2, 4, 6, 10, 16, 32, 52, and 104 weeks, and follow-up at 5, 12 and 30 years
Secondary outcome measures
1. DSM diagnosis; Timepoint(s): baseline, 10, 16, 32, 52, and 104 weeks, and follow-up at 12 and 30 years
2. Hospital admission; Timepoint(s): baseline, 2, 4, 6, 10, 16, 32, 52, and 104 weeks, and follow-up at 5, 12 and 30 years
3. Hospital Anxiety and Depression Scale - Anxiety section; Timepoint(s): baseline, 2, 4, 6, 10, 16, 32, 52, and 104 weeks, and follow-up at 5, 12 and 30 years
4. Hospital Anxiety and Depression Scale - Depression Section; Timepoint(s): baseline, 2, 4, 6, 10, 16, 32, 52, and 104 weeks, and follow-up at 5, 12 and 30 years
5. Montgomery-Asberg Depression Rating Scale; Timepoint(s): baseline, 2, 4, 6, 10, 16, 32, 52, and 104 weeks, and follow-up at 5, 12 and 30 years
6. Neurotic Disorder Outcome Scale (NDOS); Timepoint(s): baseline, 5, 12 and 30 years
personality status; Timepoint(s): baseline, 2 years, 12 and 30 years
7. Social Functioning Questionnaire; Timepoint(s): 12 and 30 years
8. Suicidal behaviour; Timepoint(s): baseline, 2, 4, 6, 10, 16, 32, 52, and 104 weeks, and follow-up at 5, 12 and 30 years
Overall trial start date
01/01/2014
Overall trial end date
30/06/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. On no active treatment at baseline
2. Satisfies diagnostic criteria for GAD, dysthymia or panic disorder
3. Target Gender: Male & Female
The participants to the original trial (Tyrer et al, 1988) were:
1. Aged between 18 and 65
2. Seen in general practice psychiatric clinics
3. Following the diagnostic criteria of the then new American diagnostic classification (DSM-III)) had a diagnosis of dysthymia (formerly neurotic depression), generalised anxiety disorder or panic disorder
4. Were not on any form of therapy for mental disorder at the time of randomisation
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
Planned Sample Size: 130; UK Sample Size: 130; Description: Patients with a DSM-III diagnosis of generalised anxiety disorder, dysthymia and panic disorder seen in general practice psychiatric clinics
Participant exclusion criteria
Lack of informed consent
Recruitment start date
01/01/2014
Recruitment end date
30/06/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Psychological Medicine
London
W6 8RP
United Kingdom
Sponsor information
Organisation
Imperial College London (UK)
Sponsor details
Joint Research Compliance Office
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Department of Health Offender Health (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Nicola Pigott Memorial Fund (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
31/12/2020
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2019 mortality paper in https://www.ncbi.nlm.nih.gov/pubmed/31414571 (added 06/12/2019)