Condition category
Mental and Behavioural Disorders
Date applied
25/11/2015
Date assigned
25/11/2015
Last edited
09/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Unipolar depressive disorder (UDD), commonly referred to as depression, is one of the most common mental health conditions worldwide. The symptoms of UDD can vary greatly from person to person, but they generally include low mood, problems with sleeping and/or eating, and a general loss of interest in life. Treatment often relies on antidepressant medications, which work by increasing the activity and levels of a group of chemicals in the brain (neurotransmitters), and psychological (talking) therapies, such as cognitive behavioural therapy (CBT). In most cases, the treatment of a patient suffering from UDD is managed by specialists in the field of mental health (secondary care). It has been found however, that around 40% of patients with UDD treated in secondary care do not recover after receiving the generally treatments that are offered primarily. It may be a more effective option to tailor the type of treatment a patient receives to their individual needs. The aim of this study is to find out whether individual care from a team of specialists in mood disorders is a more effective treatment for depression than usual treatment options available.

Who can participate?
Adults who are suffering from depression, who have been under the care of a specialist mental health team for the last six months.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are treated by a specialist mood disorders team, including a psychiatrist (a doctor who specialises in mental health) and a psychologist (a non-medical expert in psychology). The team assesses each individual participant to come up with a treatment plan involving medication and talking therapy, which is tailored to their specific needs. Those in the second group continue to have their usual treatment for the duration of the study. At the start of the study, and then again every 6 months until the end of the 36 month study period, participants in both groups complete questionnaires designed to measure how depressed they are and how well they are coping with daily life.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University of Nottingham (UK)

When is the study starting and how long is it expected to run for?
September 2009 to July 2013

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Catherine Kaylor-Hughes

Trial website

Contact information

Type

Scientific

Primary contact

Dr Catherine Kaylor-Hughes

ORCID ID

Contact details

Institute of Mental Health Sir Colin Campbell Building
University Of Nottingham Innovation Park
Triumph Road
Nottingham
NG7 2TU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01047124

Protocol/serial number

11111

Study information

Scientific title

Randomised controlled trial of the clinical and cost effectiveness of a specialist mood disorders team for refractory unipolar depressive disorder

Acronym

Study hypothesis

The aim of this study is determine whether a specialised mood disorder service, which offers tailored psychological and pharmacological treatment, is effective and cost-effective in the treatment of chronic unipolar depressive disorder.

Ethics approval

09/H0405/42

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

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: Depression; Disease: Depression

Intervention

Participants are randomly allocated to one of two groups.

Intervention group: Participants will be assessed and treated by a specialist mood disorders team for a period of 36 months. The specialist mood disorders team will include a psychiatrist and psychologist, who will assess participants and then provide a co-ordinated and supervised combination of pharmacological and psychological treatment according to guidelines developed by NICE and the British Association of Psychopharmacology. Each participant will receive a treatment plan that is tailored to his/her specific needs.

Control group: Participants receive treatment as usual for the duration of the study.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Depression assessed using the Hamilton Depression Rating Scale at baseline, 6, 12, 18, 24 and 36 months

Secondary outcome measures

Functional ability assessed using the Global Assessment of Functioning scale at baseline, 6, 12, 18, 24 and 36 months

Overall trial start date

01/09/2009

Overall trial end date

11/07/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged over 18 years
2. Able and willing to give oral and written informed consent to participate in the study
3. Suffering from primary unipolar depression which is not a consequence of having another axis 1 or 2 psychiatric disorder
4. From the date of first assessment by a health professional working within the index mental health trust, primary care trust or third sector, they must have been offered or received direct and continuous care from one or more health professionals in the preceding 6 months. They must currently be under the care of a secondary care mental health team.
5. Meets NICE criteria for moderate depression (five out of nine symptoms of depression (NICE, 2004)); has a Hamilton Depression Rating Scale of at least 16; and score 60 or less on the Global Assessment of Functioning Scale (American Psychiatric Association, 1994).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 222; UK Sample Size: 222; Description: 174 patients plus 40 – 48 staff

Participant exclusion criteria

1. Is receiving emergency care for suicide risk, risk of severe neglect or homicide risk. However, patients will not be excluded because of such risk provided the risk is adequately contained within their current care setting and the primary medical responsibility for care remains with the referring team.
2. Does not speak fluent English
3. Pregnancy (female participants)

Recruitment start date

01/09/2009

Recruitment end date

11/07/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Nottingham
Institute of Mental Health Sir Colin Campbell Building University Of Nottingham Innovation Park Triumph Road
Nottingham
NG7 2TU
United Kingdom

Sponsor information

Organisation

University of Nottingham

Sponsor details

University Park
Nottingham
NG7 2RD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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

2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21114826
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27498098

Publication citations

Additional files

Editorial Notes

09/08/2016: Publication reference added.