Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/07/2009
Date assigned
27/08/2009
Last edited
27/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.gla.ac.uk/

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

Publication citations

Additional files

Editorial Notes

27/01/2016: No publications found on PubMed.