Contact information
Type
Scientific
Primary contact
Mrs Dorothy McMenemie
ORCID ID
Contact details
Diabetes Centre
Inverclyde Royal Hospital
Greenock
PA16 0XN
United Kingdom
+44 1475 504868
dorothymcm@aol.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised controlled trial of group sessions of cognitive behavioural therapy for people with anxiety and depression following a new diagnosis of diabetes
Acronym
DADS (Diabetes Anxiety and Depression Study)
Study hypothesis
Group sessions of cognitive behavioural therapy (CBT) can improve diabetic control in patients newly diagnosed with diabetes who also have anxiety and depression.
Ethics approval
Argyll and Clyde NHS Health Board Local Research Ethics Committee (LREC), 13/09/2002, ref: LREC 48/02
Study design
Randomised controlled intervention trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Diabetes type 1 and 2, anxiety and/or depression
Intervention
Diabetic patients whose Hospital Anxiety and Depression Scale (HADS) score indicated anxiety and depression (greater than or equal to 11 on either HADS-A or HADS-D or a total of both scores together (HADS-T) of greater than or equal to 18), were randomised by a computerised randomisation system to either cognitive behavioural therapy (CBT) delivered in group sessions over a six week period or to a control of standard care. Patients whose HADS score did not indicate anxiety or depression continued as an observation group.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The difference in glycaemic control 12 months from baseline as measured by HbA1c.
Secondary outcome measures
1. The change in depression and anxiety as measured by HADS 12 months from baseline
2. The change in quality of life as measured by the 36-item short form health survey version 2 (SF-36V2), 12 months from baseline
Overall trial start date
15/09/2002
Overall trial end date
05/02/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. New diagnosis of diabetes (less than 12 months)
2.18 years of age and above, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
608: 103 to treatment arm, 104 to control arm, 401 to observation group
Participant exclusion criteria
1. Patients with a poor understanding of English
2. Patients whose mental health requires immediate referral to a psychiatrist
3. Patients too physically impaired to attend group sessions
Recruitment start date
15/09/2002
Recruitment end date
05/02/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Diabetes Centre
Greenock
PA16 0XN
United Kingdom
Sponsor information
Organisation
University of Glasgow (UK)
Sponsor details
University Avenue
Glasgow
G12 8QQ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Novo Nordisk Research Foundation (UK) - university tuition fees
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Inverclyde Royal Hospital (UK) - Endowment Fund (diabetes)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University of Glasgow (UK) - statistical support
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