Type 2 DiabetesNCT01182701
Cognitive Behavioral Intervention in Diabetes Self-Management
A study testing Cognitive behavioral training in people with Type 2 Diabetes, run by University of Hawaii at 1 site in United States.
Trial summary
The proposed study is a two arm randomized controlled trial with longitudinal follow-up that compares cognitive behavioral interventions (ENHANCE) to a control group with attention. The experiment will consist of a repeated measure 2 X 3 design; Condition (Experiment vs. Control) by Time (Pre, Post, Follow Up). Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Cognitive behavioral training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Feb 2010
- 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 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Asian/Pacific Islander Men and Women with type 2 diabetes; asymptomatic for hyperglycemia
- Both men and women will be included in the study if they have a diagnosis of type 2 diabetes made by a physician and meet classification and diagnostic criteria established by the American Diabetes Association (American Diabetes Association, 1997)
- Between 18 and 76 years
- Participation in diabetes education program of University Specialty Clinics
Who cannot join
- Crippling arthritis
- Joint replacements that limit movement
- Neuromuscular disease with paralysis
- Severe eye disease or visually impaired
- Chronic renal failure and/or End Stage Renal Disease requiring hemodialysis or peritoneal dialysis
- Transplant recipient
Show all 14Show fewer
- Foot Amputation
- Congestive Heart Failure
- New York Heart Class III/IV
- Previous Cerebral Vascular Accident (stroke) with residual paralysis
- Malignancy
- Chronic hepatitis C
- HIV disease
- Individuals who contemplate changing residence within the period of study and becoming inaccessible to the study should be discouraged from the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Hawaii School of Nursing & Dental Hygiene
Honolulu, Hawaii, 96822
About this study
The proposed study is a two arm randomized controlled trial with longitudinal follow-up that compares cognitive behavioral interventions (ENHANCE) to a control group with attention. The experiment will consist of a repeated measure 2 X 3 design; Condition (Experiment vs. Control) by Time (Pre, Post, Follow Up).
- Conditions
- Type 2 Diabetes
- Being tested
- Cognitive behavioral training
- Keywords
- Type 2 Diabetes, Asian Pacific Islanders, Cognitive behavioral intervention
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral trainingBehavioural
The behavioral training group will be involved six group sessions focusing on cognitive behavioral training for stress and mood management, cognitive restructuring, empowerment, values clarification, problem solving and decision making via a manualized program
| Study group | Role | What they receive |
|---|---|---|
| Behavioral intervention | Active comparator | Not described Receives: Behavioral: Cognitive behavioral training |
| Education support | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.
Measured: Baseline
Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.
Measured: Post (6 weeks)
Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.
Measured: 6 months
Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.
Measured: 1 year
Secondary outcomes (4)
Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.
Measured: Baseline
Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.
Measured: Post (6 weeks)
Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.
Measured: 6 months
Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startAug 2004
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Investigators
- Jillian Inouye, PhD, APRN, Principal investigator, Universtiy of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182701
- Sponsor's protocol ID
- 5R01NR007883
- Status last verified
- Aug 2010
- First submitted
- 6 Aug 2010
- Last updated
- 17 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Intervention in Diabetes Self-Management
- ClinicalTrials.gov ID
- NCT01182701
- Acronym / sponsor ID
- 5R01NR007883
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Asian Pacific Islanders, Cognitive behavioral intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 17 Aug 2010 (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.
The proposed study is a two arm randomized controlled trial with longitudinal follow-up that compares cognitive behavioral interventions (ENHANCE) to a control group with attention. The experiment will consist of a repeated measure 2 X 3 design; Condition (Experiment vs. Control) by Time (Pre, Post, Follow Up).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral intervention | Active comparator | Behavioral: Cognitive behavioral training |
| Education support | No intervention | – |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Asian/Pacific Islander Men and Women with type 2 diabetes; asymptomatic for hyperglycemia
- Both men and women will be included in the study if they have a diagnosis of type 2 diabetes made by a physician and meet classification and diagnostic criteria established by the American Diabetes Association (American Diabetes Association, 1997)
- Between 18 and 76 years
- Participation in diabetes education program of University Specialty Clinics
Key exclusion criteria (14 listed)
- Crippling arthritis
- Joint replacements that limit movement
- Neuromuscular disease with paralysis
- Severe eye disease or visually impaired
- Chronic renal failure and/or End Stage Renal Disease requiring hemodialysis or peritoneal dialysis
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 |
|---|---|---|
| Cognitive behavioral trainingThe behavioral training group will be involved six group sessions focusing on cognitive behavioral training for stress and mood management, cognitive restructuring, empowerment, values clarification, problem solving and decision making via a manualized program | Behavioural | Behavioral intervention |
Primary outcome
Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.
Time frame: Baseline
Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.
Time frame: Post (6 weeks)
Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.
Time frame: 6 months
Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression.
Time frame: 1 year
4 secondary outcomes
Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.
Time frame: Baseline
Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.
Time frame: Post (6 weeks)
Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.
Time frame: 6 months
Determine the effectiveness of a cognitive/behavioral intervention program in enhancing adherence to self-management strategies.
Time frame: 1 year
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 Aug 2010.
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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.
Jillian Inouye, PhD, APRN principal investigator
Universtiy of Hawaii
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral training in people with Type 2 Diabetes, run by University of Hawaii at 1 site in United States.
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 4 inclusion and 14 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 Aug 2010. 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 United States. 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?
Determine the effectiveness of a cognitive/behavioral intervention program in improving health outcomes of quality of life, general health, glycemic control, and depression. (time frame: Baseline). The study lists 4 primary outcomes in all. 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 Aug 2010.