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Trial of the Clinical and Cost Effectiveness of a Specialist Expert Mood Disorder Team for Refractory Unipolar Depressive Disorder

Primary Purpose

Chronic Unipolar Depressive Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Specialist Mood Disorders Team
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Unipolar Depressive Disorder focused on measuring Depression, Collaborative Care, Cognitive Behaviour Therapy, Mental Health Services, Antidepressants

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The responsible medical officer or care coordinator leading care considers the patient to be suffering from a primary unipolar depressive disorder which is not a consequence of having another axis 1 or 2 psychiatric disorder.
  • Age over 18 years.
  • Able and willing to give oral and written informed consent to participation in the study.
  • From the date of first assessment by a health professional working for the index mental health trust, they have been offered or received direct care from one or more health professionals from the Trust three or more occasions for 6 months.
  • Meet NICE criteria for moderate depression, namely the presence of five out of nine symptoms of (NICE, 2004), have a Hamilton Depression Rating Scale of at least 20, and score 60 or less on the Global Assessment of Functioning Scale (American Psychiatric Association, 1994).

Exclusion Criteria:

  • Is receiving emergency care for suicide risk, risk of severe neglect or homicide risk and requires it; however, patients will not be excluded because of such risk provided the risk is adequately contained with their current care setting and the primary medical responsibility for care remains with the referring team.
  • Does not speak fluent English.
  • Is pregnant

Sites / Locations

  • Derbyshire Mental Health NHS Trust
  • Lincolnshire Partnership Trust
  • Nottinghamshire Healthcare NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Treatment as usual

Arm Description

Specialist mood disorders team: treatment plan according to need

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale - Grid version

Secondary Outcome Measures

Change in self rated depression measures: Beck Depression Inventory version 1; Personal Health Questionnaire; Quick Inventory of Depressive Symptomology
Cost utility or cost effectiveness using the Euroqol 5D as a measure of quality of life and costs from health and social care and society perspectives.
Change in social adjustment (Cooper, Osborn, Gath & Feggetter, 1982), an assessment of social and occupational functioning.
Patient satisfaction and patient/doctor relationship

Full Information

First Posted
January 11, 2010
Last Updated
December 8, 2015
Sponsor
University of Nottingham
Collaborators
National Institute for Health Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT01047124
Brief Title
Trial of the Clinical and Cost Effectiveness of a Specialist Expert Mood Disorder Team for Refractory Unipolar Depressive Disorder
Official Title
Randomised Control Trial of the Clinical and Cost Effectiveness of a Specialist Expert Mood Disorder Team for Refractory Unipolar Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
Collaborators
National Institute for Health Research, United Kingdom

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is determine whether a specialised mood disorder service, which offers tailored psychological and pharmacological treatment, is more effective in the treatment of chronic unipolar depressive disorder then treatment as usual.
Detailed Description
A pragmatic randomised controlled trial of a specialist mood disorder intervention versus treatment as usual will be conducted. Patients will be individually randomised with stratification by mental health trust to either treatment by a specialist team offering tailored psychological and pharmacological treatment or treatment as usual. The specialist mood disorders team will include a psychiatrist and health professionals providing cognitive behaviour therapy. Together the team 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. The participants in the treatment as usual team will have their usual access to the same treatments. The outcome in terms of improvement in depressive symptoms, function and costs will be examined after one year in service users with chronic depression. Eligible patients will be followed for 12 months and the primary outcomes will be observer rated depressive symptoms and cost effectiveness from a health and social care perspective. Along side the RCT, implementation analysis and audit of the standard care and specialised care for depression will be carried out.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Unipolar Depressive Disorder
Keywords
Depression, Collaborative Care, Cognitive Behaviour Therapy, Mental Health Services, Antidepressants

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
219 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Specialist mood disorders team: treatment plan according to need
Arm Title
Treatment as usual
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Specialist Mood Disorders Team
Other Intervention Name(s)
Collaborative care for depression
Intervention Description
The specialist mood disorders team will include a psychiatrist and health professionals providing cognitive behaviour therapy. Together the team 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.
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale - Grid version
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in self rated depression measures: Beck Depression Inventory version 1; Personal Health Questionnaire; Quick Inventory of Depressive Symptomology
Time Frame
3 months
Title
Cost utility or cost effectiveness using the Euroqol 5D as a measure of quality of life and costs from health and social care and society perspectives.
Time Frame
6 months
Title
Change in social adjustment (Cooper, Osborn, Gath & Feggetter, 1982), an assessment of social and occupational functioning.
Time Frame
6 months
Title
Patient satisfaction and patient/doctor relationship
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The responsible medical officer or care coordinator leading care considers the patient to be suffering from a primary unipolar depressive disorder which is not a consequence of having another axis 1 or 2 psychiatric disorder. Age over 18 years. Able and willing to give oral and written informed consent to participation in the study. From the date of first assessment by a health professional working for the index mental health trust, they have been offered or received direct care from one or more health professionals from the Trust three or more occasions for 6 months. Meet NICE criteria for moderate depression, namely the presence of five out of nine symptoms of (NICE, 2004), have a Hamilton Depression Rating Scale of at least 20, and score 60 or less on the Global Assessment of Functioning Scale (American Psychiatric Association, 1994). Exclusion Criteria: Is receiving emergency care for suicide risk, risk of severe neglect or homicide risk and requires it; however, patients will not be excluded because of such risk provided the risk is adequately contained with their current care setting and the primary medical responsibility for care remains with the referring team. Does not speak fluent English. Is pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah E Marttunen, MSc
Phone
+44(0)1158232478
Email
sarah.marttunen@nottingham.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Morriss
Phone
+44(0)115820427
Email
richard.morriss@nottingham.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Morriss
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Derbyshire Mental Health NHS Trust
City
Derby
State/Province
Derbyshire
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marttunen
Phone
+44(0)1158232478
First Name & Middle Initial & Last Name & Degree
Paul Gilbert, MSc, PhD, Dip Clin Psyc, FBPsS
Facility Name
Lincolnshire Partnership Trust
City
Lincoln
State/Province
Lincolnshire
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marttunen
Phone
+44(0)1158232478
First Name & Middle Initial & Last Name & Degree
Simon Loosmore, MB ChB, MRCpsych
Facility Name
Nottinghamshire Healthcare NHS Trust
City
Nottingham
State/Province
Nottinghamshire
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marttunen
Phone
+44(0)1158232478
First Name & Middle Initial & Last Name & Degree
Richard Morriss, MBChB, MRCpsych, MMedSci, MD

12. IPD Sharing Statement

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Trial of the Clinical and Cost Effectiveness of a Specialist Expert Mood Disorder Team for Refractory Unipolar Depressive Disorder

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