Dealing With Anxiety: A Cognitive Behavioural Program for Diabetes
Primary Purpose
Diabetes Mellitus Type 2
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Immediate Cognitive behavioural therapy (CBT)
Delayed CBT
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 2 focused on measuring diabetes, cognitive behavioural therapy
Eligibility Criteria
Inclusion Criteria:
- Consenting attendees of the Hunter Area Diabetes Services RNH Diabetes Outpatient Clinic
Exclusion Criteria:
Accessibility problems including:
- limited English
- developmental disability
- physical immobility
- geographical distance
- extreme age/frailty
Sites / Locations
- Royal Newcastle Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Hemoglobin A1C (HbA1C)
Secondary Outcome Measures
Depression Anxiety Stress Scale (DASS)
Diabetes Quality of Life (ADDQoL)
Full Information
NCT ID
NCT00659932
First Posted
April 14, 2008
Last Updated
April 14, 2008
Sponsor
Hunter and New England Health
1. Study Identification
Unique Protocol Identification Number
NCT00659932
Brief Title
Dealing With Anxiety: A Cognitive Behavioural Program for Diabetes
Official Title
Dealing With Anxiety: A Pilot Cognitive Behavioural Program for Diabetic Clinic Outpatient Attendees
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hunter and New England Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Having co-morbid anxiety or depression makes it difficult to carry out the activities for diabetes selfcare. Psychological interventions have been shown to result in improvements in HbA1C and depression. Reports on psychosocial outcomes are conflicting and there are no studies of quality of life. Our diabetes outpatient population has a higher prevalence of anxiety and depression compared to the general public and this led to the development of a group CBT intervention designed to reduce anxiety as a co-morbidity of diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2
Keywords
diabetes, cognitive behavioural therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Immediate Cognitive behavioural therapy (CBT)
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Delayed CBT
Intervention Description
Commencement of the CBT Group Program is delayed 3 months
Primary Outcome Measure Information:
Title
Hemoglobin A1C (HbA1C)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Depression Anxiety Stress Scale (DASS)
Time Frame
6 months
Title
Diabetes Quality of Life (ADDQoL)
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Consenting attendees of the Hunter Area Diabetes Services RNH Diabetes Outpatient Clinic
Exclusion Criteria:
Accessibility problems including:
limited English
developmental disability
physical immobility
geographical distance
extreme age/frailty
Facility Information:
Facility Name
Royal Newcastle Hospital
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2300
Country
Australia
12. IPD Sharing Statement
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Dealing With Anxiety: A Cognitive Behavioural Program for Diabetes
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