DepressionNCT02185482
Physician Led Counseling in Management of Depression in Type 2 Diabetes Mellitus
A study testing Physician Supported Care in people with Depression and Type 2 Diabetes Mellitus, run by Adwin Life Care at 2 sites in India.
Trial summary
There is a high prevalence of depression in patients with diabetes mellitus. Depression has been shown to be associated with poor self-management (adherence to diet, exercise, checking blood glucose levels) levels in patients with diabetes.To determine whether enhancing quality physician's care for depression improves… Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Depression, Type 2 Diabetes Mellitus
- What is being tested?
- Physician Supported Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesIndia
- Study dates
- Aug 2014to Nov 2015
- 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Eligible patients are ambulatory,
- Had adequate hearing to complete a telephone interview,
- Diabetic patients screened for depression
Who cannot join
- Currently in care with a psychiatrist;
- Diagnosis of bipolar disorder or schizophrenia;
- Use of antipsychotic or mood stabilizer medication
- Mental confusion on interview, suggesting significant dementia.
Trial locations and contacts
2 sites in 1 country.
India2 sites
GyanSanjeevani
Jaipur, Rajasthan
NMP Medical Research Institute
Kaithal, Haryana
About this study
Official title: Physician Led Counseling for Depression in Type 2 Diabetes Mellitus: A Randomized, Controlled Trial
There is a high prevalence of depression in patients with diabetes mellitus. Depression has been shown to be associated with poor self-management (adherence to diet, exercise, checking blood glucose levels) levels in patients with diabetes.To determine whether enhancing quality physician's care for depression improves both depression and diabetes outcomes in patients with depression and diabetes.
- Conditions
- Depression, Type 2 Diabetes Mellitus
- Being tested
- Physician Supported Care, Usual care
- Keywords
- Psychological counselling, Randomized single blind study, Depression, Diabetes
- Medical subject headings
- Depression, 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.
Physician Supported CareBehavioural
Usual careOther
| Study group | Role | What they receive |
|---|---|---|
| Physician Supported Care | Experimental | The intervention is an individualized, stepped-care depression treatment program provided by a depression clinical specialist primary care physician. Receives: Behavioral: Physician Supported Care |
| Usual care | Other | Usual care patients will be advised to consult with their primary care physician regarding depression. Primary care physicians prescribe antidepressant medication and can refer patients to the Mental Health Services. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in depression using SCL-90 depression scale
Measured: Change from baseline to six month
Secondary outcomes (1)
Glycemic control measured using glycosylated hemoglobin levels
Measured: Change from baseline to six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2015
- Study completionNov 2015
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adwin Life Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NMP Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Ram Sharma, MD, Study director, NMP Medical Research InstituteNaresh C Kumar, MD, Principal investigator, Kaithal Civil Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185482
- Sponsor's protocol ID
- Adwin112
- Status last verified
- Jan 2016
- First submitted
- 4 Jul 2014
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician Led Counseling for Depression in Type 2 Diabetes Mellitus: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02185482
- Acronym / sponsor ID
- Adwin112
- Conditions
- Depression, Type 2 Diabetes Mellitus
- Keywords
- Psychological counselling, Randomized single blind study, Depression, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Adwin Life CareIndustry (pharma, biotech, devices)
- Collaborators
- NMP Medical Research Institute
- Study start
- Aug 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 9 Jul 2014 (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.
There is a high prevalence of depression in patients with diabetes mellitus. Depression has been shown to be associated with poor self-management (adherence to diet, exercise, checking blood glucose levels) levels in patients with diabetes.To determine whether enhancing quality physician's care for depression improves both depression and diabetes outcomes in patients with depression and diabetes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physician Supported Care | Experimental | Behavioral: Physician Supported CareThe intervention is an individualized, stepped-care depression treatment program provided by a depression clinical specialist primary care physician. |
| Usual care | Other | Other: Usual careUsual care patients will be advised to consult with their primary care physician regarding depression. Primary care physicians prescribe antidepressant medication and can refer patients to the Mental Health Services. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Eligible patients are ambulatory,
- Had adequate hearing to complete a telephone interview,
- Diabetic patients screened for depression
Key exclusion criteria (4 listed)
- Currently in care with a psychiatrist;
- Diagnosis of bipolar disorder or schizophrenia;
- Use of antipsychotic or mood stabilizer medication
- Mental confusion on interview, suggesting significant dementia.
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 |
|---|---|---|
| Physician Supported Care | Behavioural | Physician Supported Care |
| Usual care | Other | Usual care |
Primary outcome
change in depression using SCL-90 depression scale
Time frame: Change from baseline to six month
1 secondary outcome
Glycemic control measured using glycosylated hemoglobin levels
Time frame: Change from baseline to six month
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 5 Feb 2016.
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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.
Ram Sharma, MD study director
NMP Medical Research Institute
Naresh C Kumar, MD principal investigator
Kaithal Civil Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician Supported Care in people with Depression and Type 2 Diabetes Mellitus, run by Adwin Life Care at 2 sites in India.
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 3 inclusion and 4 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 5 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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?
change in depression using SCL-90 depression scale (time frame: Change from baseline to six month). 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 5 Feb 2016.