Dealing With Anxiety: A Cognitive Behavioural Program for Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Behavioral: Delayed CBT; Behavioral: Immediate Cognitive behavioural therapy (CBT)

• Registration Number: NCT00659932
• Lead Sponsor: Hunter and New England Health

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.

Study Timeline

• Study Start: 2002-05
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Status Verified: 2007-12
• Study First Submitted: 2008-04-14
• Study First Submitted QC: 2008-04-14
• Last Update Submitted: 2008-04-14
• Study First Posted: 2008-04-17
• Last Update Posted: 2008-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Delayed CBT	-
1	Immediate Cognitive behavioural therapy (CBT)	-

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1C (HbA1C)	6 months

Secondary Outcome Measures

Name	Time	Method
Depression Anxiety Stress Scale (DASS)	6 months
Diabetes Quality of Life (ADDQoL)	6 months

Trial Locations

Locations (1)

Royal Newcastle Hospital; 🇦🇺 Newcastle, New South Wales, Australia