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Dealing With Anxiety: A Cognitive Behavioural Program for Diabetes

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ClinicalTrials.gov Identifier: NCT00659932
Recruitment Status : Completed
First Posted : April 17, 2008
Last Update Posted : April 17, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Behavioral: Immediate Cognitive behavioural therapy (CBT) Behavioral: Delayed CBT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 2002
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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




Primary Outcome Measures :
  1. Hemoglobin A1C (HbA1C) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Depression Anxiety Stress Scale (DASS) [ Time Frame: 6 months ]
  2. Diabetes Quality of Life (ADDQoL) [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659932


Locations
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Australia, New South Wales
Royal Newcastle Hospital
Newcastle, New South Wales, Australia, 2300
Sponsors and Collaborators
Hunter and New England Health

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Responsible Party: Dr Kerry Bowen, Hunter and New England Health
ClinicalTrials.gov Identifier: NCT00659932     History of Changes
Other Study ID Numbers: 02/03/13/3.18
First Posted: April 17, 2008    Key Record Dates
Last Update Posted: April 17, 2008
Last Verified: December 2007
Keywords provided by Hunter and New England Health:
diabetes
cognitive behavioural therapy
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases