Diabetes Mellitus Type 2NCT00659932
Dealing With Anxiety: A Cognitive Behavioural Program for Diabetes
A study testing Immediate Cognitive behavioural therapy (CBT) and Delayed CBT in people with Diabetes Mellitus Type 2, run by Hunter and New England Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Immediate Cognitive behavioural therapy (CBT) and Delayed CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteAustralia
- Study dates
- May 2002to Mar 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Consenting attendees of the Hunter Area Diabetes Services RNH Diabetes Outpatient Clinic
Who cannot join
- Accessibility problems including:
- limited English
- developmental disability
- physical immobility
- geographical distance
- extreme age/frailty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dealing With Anxiety: A Pilot Cognitive Behavioural Program for Diabetic Clinic Outpatient Attendees
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.
Read the 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.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Immediate Cognitive behavioural therapy (CBT), Delayed CBT
- Keywords
- diabetes, cognitive behavioural therapy
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Cognitive behavioural therapy (CBT)Behavioural
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 CBTBehavioural
Commencement of the CBT Group Program is delayed 3 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Immediate Cognitive behavioural therapy (CBT) |
| 2 | Active comparator | Not described Receives: Behavioral: Delayed CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C (HbA1C)
Measured: 6 months
Secondary outcomes (2)
Depression Anxiety Stress Scale (DASS)
Measured: 6 months
Diabetes Quality of Life (ADDQoL)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startMay 2002
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunter and New England Health
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659932
- Sponsor's protocol ID
- 02/03/13/3.18
- Status last verified
- Dec 2007
- First submitted
- 14 Apr 2008
- Last updated
- 17 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dealing With Anxiety: A Pilot Cognitive Behavioural Program for Diabetic Clinic Outpatient Attendees
- ClinicalTrials.gov ID
- NCT00659932
- Acronym / sponsor ID
- 02/03/13/3.18
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- diabetes, cognitive behavioural therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hunter and New England HealthUniversity, hospital or other
- Study start
- May 2002
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 17 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Immediate Cognitive behavioural therapy (CBT) |
| 2 | Active comparator | Behavioral: Delayed CBT |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Consenting attendees of the Hunter Area Diabetes Services RNH Diabetes Outpatient Clinic
Key exclusion criteria (6 listed)
- Accessibility problems including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | 1 |
| Delayed CBTCommencement of the CBT Group Program is delayed 3 months | Behavioural | 2 |
Primary outcome
Hemoglobin A1C (HbA1C)
Time frame: 6 months
2 secondary outcomes
Depression Anxiety Stress Scale (DASS)
Time frame: 6 months
Diabetes Quality of Life (ADDQoL)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Cognitive behavioural therapy (CBT) and Delayed CBT in people with Diabetes Mellitus Type 2, run by Hunter and New England Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1C (HbA1C) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2008.