DepressionNCT00005116
Depression In Juvenile Diabetics
A study testing psychotherapy in people with Depression and Diabetes Mellitus, Insulin-Dependent, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Depression is one of the most common emotional problems among youths with insulin dependent diabetes mellitus (IDDM). It has been shown that depression in youths with IDDM lasts a while and may have a role in later complications of the medical condition. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Depression, Diabetes Mellitus, Insulin-Dependent
- What is being tested?
- psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- IDDM duration of less than 10 years
- No major medical disorder other than IDDM
- No psychotropic medications
- Meets psychiatric diagnostic criteria for depression
- Parent and child willing to participate
Who cannot join
- Does not live withing commuting distance
- Mental retardation
Trial locations and contacts
1 site in 1 country.
About this study
Depression is one of the most common emotional problems among youths with insulin dependent diabetes mellitus (IDDM). It has been shown that depression in youths with IDDM lasts a while and may have a role in later complications of the medical condition. And yet, there are no psychological interventions appropriate for such youngsters. The purpose of this study is to modify a treatment called ''Contextual Psychotherapy'' (that has been developed for depressed youngsters) in order to address special needs of depressed youths with IDDM, and to ''pilot test'' the treatment. The youngsters to be recruited are those being cared for at the Diabetes Clinic of the Children's Hospital of Pittsburgh. The treatment includes a 3- month phase (16 sessions), followed by a 3-month ''booster'' phase (3 sessions), and two later follow-up evaluations.
- Conditions
- Depression, Diabetes Mellitus, Insulin-Dependent
- Being tested
- psychotherapy
- Keywords
- depression
- Medical subject headings
- Depression, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychotherapyBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2000 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- Diagnosis
- Masking
- None (open label)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Dr. Maria Kovacs, Principal investigator, U. Of Pittsburgh School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005116
- Sponsor's protocol ID
- KOVACSM (completed)
- Other IDs
- R01DK025568
- Status last verified
- Mar 2010
- First submitted
- 13 Apr 2000
- Last updated
- 2 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression In Juvenile Diabetics
- ClinicalTrials.gov ID
- NCT00005116
- Acronym / sponsor ID
- KOVACSM (completed)
- Conditions
- Depression, Diabetes Mellitus, Insulin-Dependent
- Keywords
- depression
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- First posted
- 14 Apr 2000 (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.
Depression is one of the most common emotional problems among youths with insulin dependent diabetes mellitus (IDDM). It has been shown that depression in youths with IDDM lasts a while and may have a role in later complications of the medical condition. And yet, there are no psychological interventions appropriate for such youngsters. The purpose of this study is to modify a treatment called ''Contextual Psychotherapy'' (that has been developed for depressed youngsters) in order to address special needs of depressed youths with IDDM, and to ''pilot test'' the treatment. The youngsters to be recruited are those being cared for at the Diabetes Clinic of the Children's Hospital of Pittsburgh. The treatment includes a 3- month phase (16 sessions), followed by a 3-month ''booster'' phase (3 sessions), and two later follow-up evaluations.
Study design
- Primary purpose
- Diagnosis
- Masking
- None (open label)
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- IDDM duration of less than 10 years
- No major medical disorder other than IDDM
- No psychotropic medications
- Meets psychiatric diagnostic criteria for depression
- Parent and child willing to participate
Key exclusion criteria (2 listed)
- Does not live withing commuting distance
- Mental retardation
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 |
|---|---|---|
| psychotherapy | Behavioural | – |
Primary outcome
Not reported in the source record.
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 2 Mar 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.
Dr. Maria Kovacs principal investigator
U. Of Pittsburgh School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychotherapy in people with Depression and Diabetes Mellitus, Insulin-Dependent, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 5 inclusion and 2 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 2 Mar 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.
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 2 Mar 2010.