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Completed

NCT Number: NCT00659932

Dealing With Anxiety: A Cognitive Behavioural Program for Diabetes

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.

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Newcastle Hospital

Newcastle, New South Wales, 2300, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate Cognitive behavioural therapy (CBT)

Behavioral

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

Behavioral

Commencement of the CBT Group Program is delayed 3 months

Primary outcomes

  1. Hemoglobin A1C (HbA1C)

    Time frame: 6 months

Secondary outcomes

  1. Depression Anxiety Stress Scale (DASS)

    Time frame: 6 months

  2. Diabetes Quality of Life (ADDQoL)

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Hunter and New England Health

Other

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Apr 17, 2008
Registry last updated
Apr 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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