NCT00659932

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started May 2002

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2008

Completed
Last Updated

April 17, 2008

Status Verified

December 1, 2007

Enrollment Period

2.8 years

First QC Date

April 14, 2008

Last Update Submit

April 14, 2008

Conditions

Diabetes Mellitus Type 2

Keywords

diabetescognitive behavioural therapy

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1C (HbA1C)

    6 months

Secondary Outcomes (2)

  • Depression Anxiety Stress Scale (DASS)

    6 months

  • Diabetes Quality of Life (ADDQoL)

    6 months

Study Arms (2)

1

EXPERIMENTAL
Behavioral: Immediate Cognitive behavioural therapy (CBT)

2

ACTIVE COMPARATOR
Behavioral: Delayed CBT

Interventions

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

1
Delayed CBTBEHAVIORAL

Commencement of the CBT Group Program is delayed 3 months

2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Consenting attendees of the Hunter Area Diabetes Services RNH Diabetes Outpatient Clinic

You may not qualify if:

  • Accessibility problems including:
  • limited English
  • developmental disability
  • physical immobility
  • geographical distance
  • extreme age/frailty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Newcastle Hospital

Newcastle, New South Wales, 2300, Australia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 14, 2008

First Posted

April 17, 2008

Study Start

May 1, 2002

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

April 17, 2008

Record last verified: 2007-12

Locations

AU(1)