Dealing With Anxiety: A Cognitive Behavioural Program for Diabetes - Full Text View

Purpose

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.

Condition	Intervention
Diabetes Mellitus Type 2	Behavioral: Immediate Cognitive behavioural therapy (CBT) Behavioral: Delayed CBT

MedlinePlus related topics:

Anxiety Depression Diabetes Stress

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control, Parallel Assignment

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

Further study details as provided by Hunter and New England Health:

Primary Outcome Measures:

Hemoglobin A1C (HbA1C) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Depression Anxiety Stress Scale (DASS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Diabetes Quality of Life (ADDQoL) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	64
Study Start Date:	May 2002
Study Completion Date:	March 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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
2: Active Comparator	Behavioral: Delayed CBT Commencement of the CBT Group Program is delayed 3 months

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659932

Locations


Australia, New South Wales
	Royal Newcastle Hospital
	Newcastle, New South Wales, Australia, 2300

Sponsors and Collaborators

Hunter and New England Health

More Information

Responsible Party:	Hunter and New England Health ( Dr Kerry Bowen )
Study ID Numbers:	02/03/13/3.18
First Received:	April 14, 2008
Last Updated:	April 14, 2008
ClinicalTrials.gov Identifier:	NCT00659932
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by Hunter and New England Health:

diabetes

cognitive behavioural therapy

Study placed in the following topic categories:

Metabolic Diseases

Diabetes Mellitus, Type 2

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Hunter and New England Health
Information provided by:	Hunter and New England Health
ClinicalTrials.gov Identifier:	NCT00659932