Diabetes Anxiety and Depression Study: A randomised controlled trial of group sessions of cognitive behavioural therapy (CBT) for people with diabetes

ISRCTN	ISRCTN32827674
DOI	https://doi.org/10.1186/ISRCTN32827674
Secondary identifying numbers	N/A

Submission date: 10/07/2009
Registration date: 27/08/2009
Last edited: 28/02/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Dorothy McMenemie
Scientific

Diabetes Centre
Inverclyde Royal Hospital
Greenock
PA16 0XN
United Kingdom

Phone	+44 1475 504868
Email	dorothymcm@aol.com

Study information

Study design	Randomised controlled intervention trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
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
Study acronym	DADS (Diabetes Anxiety and Depression Study)
Study objectives	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(s)	Argyll and Clyde NHS Health Board Local Research Ethics Committee (LREC), 13/09/2002, ref: LREC 48/02
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	15/09/2002
Completion date	05/02/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	608: 103 to treatment arm, 104 to control arm, 401 to observation group
Key inclusion criteria	1. New diagnosis of diabetes (less than 12 months) 2.18 years of age and above, either sex
Key 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
Date of first enrolment	15/09/2002
Date of final enrolment	05/02/2007

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Diabetes Centre

Greenock
PA16 0XN
United Kingdom

Sponsor information

University of Glasgow (UK)
University/education

University Avenue
Glasgow
G12 8QQ
Scotland
United Kingdom

Website	http://www.gla.ac.uk/
"ROR"	https://ror.org/00vtgdb53

Funders

Funder type

Research organisation

Novo Nordisk Research Foundation (UK) - university tuition fees

No information available

Inverclyde Royal Hospital (UK) - Endowment Fund (diabetes)

No information available

University of Glasgow (UK) - statistical support

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

28/02/2018: No publications found, verifying study status with principal investigator.
27/01/2016: No publications found on PubMed.