Dealing With Anxiety: A Cognitive Behavioural Program for Diabetes

Diabetes Mellitus Type 2 Clinical Trial

Official title:

Dealing With Anxiety: A Pilot Cognitive Behavioural Program for Diabetic Clinic Outpatient Attendees

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00659932
• Other study ID #: 02/03/13/3.18
• Status: Completed
• Phase: N/A
• First received: April 14, 2008
• Last updated: April 14, 2008
• Start date: May 2002
• Est. completion date: March 2005

Study information

• Verified date: December 2007
• Source: Hunter and New England Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• 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
• Delayed CBT
Commencement of the CBT Group Program is delayed 3 months

Locations

Country	Name	City	State
Australia	Royal Newcastle Hospital	Newcastle	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Hunter and New England Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1C (HbA1C)		6 months	No
Secondary	Depression Anxiety Stress Scale (DASS)		6 months	No
Secondary	Diabetes Quality of Life (ADDQoL)		6 months	No