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Dealing With Anxiety: A Cognitive Behavioural Program for Diabetes

NCT ID: NCT00659932

Last Updated: 2008-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2005-03-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus Type 2

Keywords

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diabetes cognitive behavioural therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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1

Group Type EXPERIMENTAL

Immediate Cognitive behavioural therapy (CBT)

Intervention Type 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

2

Group Type ACTIVE_COMPARATOR

Delayed CBT

Intervention Type BEHAVIORAL

Commencement of the CBT Group Program is delayed 3 months

Interventions

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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

Intervention Type BEHAVIORAL

Delayed CBT

Commencement of the CBT Group Program is delayed 3 months

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hunter and New England Health

OTHER

Sponsor Role lead

Responsible Party

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Hunter and New England Health

Locations

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Royal Newcastle Hospital

Newcastle, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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02/03/13/3.18

Identifier Type: -

Identifier Source: org_study_id