Dealing With Anxiety: A Cognitive Behavioural Program for Diabetes

Sponsor

Hunter and New England Health (Other)

Overall Status

Completed

CT.gov ID

NCT00659932

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Type 2	Behavioral: Immediate Cognitive behavioural therapy (CBT) Behavioral: Delayed CBT	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2002

Actual Primary Completion Date :

Mar 1, 2005

Actual Study Completion Date :

Mar 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	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
Active Comparator: 2	Behavioral: Delayed CBT Commencement of the CBT Group Program is delayed 3 months

Arm

Intervention/Treatment

Experimental: 1

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

Active Comparator: 2

Behavioral: Delayed CBT

Commencement of the CBT Group Program is delayed 3 months

Outcome Measures

Primary Outcome Measures

Hemoglobin A1C (HbA1C) [6 months]

Secondary Outcome Measures

Depression Anxiety Stress Scale (DASS) [6 months]
Diabetes Quality of Life (ADDQoL) [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Royal Newcastle Hospital	Newcastle	New South Wales	Australia	2300

Sponsors and Collaborators

Hunter and New England Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00659932

Other Study ID Numbers:

02/03/13/3.18

First Posted:

Apr 17, 2008

Last Update Posted:

Apr 17, 2008

Last Verified:

Dec 1, 2007

Keywords provided by , ,

diabetes

cognitive behavioural therapy

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Apr 17, 2008