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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00659932




Registration number
NCT00659932
Ethics application status
Date submitted
14/04/2008
Date registered
17/04/2008
Date last updated
17/04/2008

Titles & IDs
Public title
Dealing With Anxiety: A Cognitive Behavioural Program for Diabetes
Scientific title
Dealing With Anxiety: A Pilot Cognitive Behavioural Program for Diabetic Clinic Outpatient Attendees
Secondary ID [1] 0 0
02/03/13/3.18
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Immediate Cognitive behavioural therapy (CBT)
Behaviour - Delayed CBT

Experimental: 1 -

Active Comparator: 2 -


Behaviour: Immediate Cognitive behavioural therapy (CBT)
The Dealing with Anxiety CBT Group Program comprises 7 group sessions: an initial five hour session followed by 6 three hour sessions over a three month period

Behaviour: Delayed CBT
Commencement of the CBT Group Program is delayed 3 months
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hemoglobin A1C (HbA1C)
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Depression Anxiety Stress Scale (DASS)
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Diabetes Quality of Life (ADDQoL)
Timepoint [2] 0 0
6 months

Eligibility
Key inclusion criteria
- Consenting attendees of the Hunter Area Diabetes Services RNH Diabetes Outpatient
Clinic
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Accessibility problems including:

- limited English

- developmental disability

- physical immobility

- geographical distance

- extreme age/frailty

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2005
Sample size
Target
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Newcastle Hospital - Newcastle
Recruitment postcode(s) [1] 0 0
2300 - Newcastle

Funding & Sponsors
Primary sponsor type
Other
Name
Hunter and New England Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study was designed to assess whether a cognitive behavior therapy (CBT) program for
diabetes clinic patients was acceptable, improved quality of life and produced measurable
change in levels of depression, anxiety and stress.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00659932
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00659932