Chronic DiseaseNCT02310932
Improving Mental Health Through Integration With Primary Care in Rural Karnataka
A study testing Healthy Living Intervention in people with Chronic Disease and Depression, run by University of California, San Francisco at 1 site in India.
Trial summary
This cluster Randomized Controlled Trial was designed to implement and evaluate the effects of a multi-level intervention designed to integrate mental health treatment into rural primary health clinics in South India using a collaborative care model. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Chronic Disease, Depression, Anxiety
- What is being tested?
- Healthy Living Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,507 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2015to Dec 2019
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 30 years or older;
- Diagnosed with co-morbid CMD (Depression or Anxiety Disorder) and either
- Able and willing to consent and participate in the intervention and all assessments;
- Able to speak Kannada; and
- Mentally competent to provide consent and answer to study measures and participate in intervention (MMSE score greater than 26).
Who cannot join
- Under 30 years of age;
- Patients who are not diagnosed with co-morbid CMD (Depression or Anxiety Disorder) and either hypertension, diabetes, or diagnosed ischemic heart disease;
- Not mentally competent to provide consent and answer to study measures and participate in intervention (MMSE score > 26).
- Unable to speak Kannada; and
- Participants who do not provide contact information.
Trial locations and contacts
1 site in 1 country.
India1 site
St. John & Research Institute/St John & Medical College & Hospital
Bangalore, Karnataka, 560 034
About this study
This cluster Randomized Controlled Trial was designed to implement and evaluate the effects of a multi-level intervention designed to integrate mental health treatment into rural primary health clinics in South India using a collaborative care model.
Read the detailed description
The prevalence of chronic non-communicable diseases, including cardiovascular disease (CVD), type-2 diabetes (DM), and common mental disorders (CMD), i.e. anxiety \& depression, are increasing worldwide, including in India, where patients with CMD are underserved, especially in rural areas, due to both stigma and lack of trained providers.
Treatment of patients with dual diagnoses involves special challenges and, if left untreated, mental illness can contribute to non-adherence and worsened outcomes.
Similarly, lack of staff training in India's Primary Health Centers (PHC) can result in missed diagnoses, inappropriate treatment, and increased morbidity and suffering. A growing body of research suggests that some of these challenges can be overcome by integrating treatment of patients with co-morbid diagnoses, by using "stepped" or "collaborative" care models. Such integration may also help reduce the stigma of seeking mental health services.
We plan to address this need by implementing and evaluating a multi-level integrated intervention in collaboration with 50 Primary Health Clinics (PHC) in rural Karnataka using a cluster Randomized Controlled Trial (cRCT). Our approach is based on our team's previous clinical and behavioral research in this region and builds on a decade long collaboration between St. John's Research Institute and University of California San Francisco. This study brings together an Indo-US team of scientists and government representatives with expertise in treating and studying mental health, chronic diseases, behavior change, stigma, and in conducting large clinical trials in rural India. It also builds on the work by India's National Rural Health Mission (NRHM), which recently announced that it will add tobacco control to its agenda. If successful, this intervention thus has high potential for scale-up and sustainability.
The proposed intervention is informed by a Social Ecological Paradigm that articulates the relationship between social settings and health behavior. It uses behavior change strategies guided by Cognitive Social Theory. Patients in intervention PHCs will receive integrated collaborative clinic care by their physicians, a nurse case manager and consulting psychiatrists. They will also participate in 12-month community-based "Healthy Living groups," in which cognitive and behavioral strategies are used to target health promoting behaviors, such as increased activity, improved diet, adherence to medical regimens, as well as problem-solving skills, coping skills, and social support. These groups will initially be co-facilitated by a Master's level mental health professional and a trained lay community health outreach worker (ASHA) on a weekly basis for 3 months. During the remaining 9 months, the ASHA will conduct monthly booster sessions focusing on the maintenance of the acquired health-promoting behaviors. Patients in control PHCs will receive an "enhanced standard" care model, which includes providing referrals for mental health needs.
To ensure standardization of study procedures across settings, all control PHC staff will receive basic training in established clinical protocols, plus training in the prescription of anti-depressant medication. While this may represent somewhat of an intervention, we did not consider it ethical to allow clinically depressed patients to be treated with vitamins and anxiolytics, which are currently frequently used in the PHC.
Following a brief start-up phase to adapt measures and finalize protocols, we propose to:
- Use ASHAs to conduct community-based screening of depression, anxiety, DM and CVD risk factors during community health fairs in the catchment areas of 25 PHCs to examine a) whether this increases subsequent diagnoses in the PHC of patients with co-morbid mental health and chronic disease diagnoses and b) whether such patients are as likely to enter and remain in treatment, compared to the standard PHC-based screening.
- Implement and evaluate the effects of providing staff training in the collaborative care model of integrated mental health (depression, anxiety) and cardiovascular disease (hypertension, diabetes, CVD) to intervention PHC staff and compare them to control PHC staff with respect to a) knowledge and clinical skills using clinical patient vignettes, and b) perceived satisfaction reported by clinic patients in intervention and control PHCs.
- Implement and evaluate the effects of our, multi-level integrated clinic and community-based intervention for co-morbid primary care patients compared to the enhanced standard non-integrated treatment services in a cRCT with 50 participating PHC, with regard to both mental health (depression and anxiety) and physical health (diabetes and cardiovascular disease) outcomes at post intervention, 6 month and 12 month follow up.
- Conditions
- Chronic Disease, Depression, Anxiety
- Being tested
- Healthy Living Intervention
- Keywords
- mental health, cardiovascular disease, diabetes, hypertension, high blood pressure
- Medical subject headings
- Chronic Disease, Depression, Anxiety Disorders, Psychological Well-Being, Cardiovascular Diseases, Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Living InterventionBehavioural
Patients in the intervention groups will receive integrated collaborative clinic care by their physicians, a nurse case manager and consulting psychiatrists. They will also participate in 12-month community-based "Healthy Living groups," in which cognitive and behavioral strategies are used to target health promoting behaviors, such as increased activity, improved diet, adherence to medical regimens, as well as problem-solving skills, coping skills, and social support.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Living Intervention | Experimental | The Healthy Living Intervention group will participate in an intervention designed to improve depression, anxiety, diabetes and CVD outcomes. This will be achieved through a 12 month intervention which consists of participation in healthy living groups and integrated collaborative clinic care at their Primary Health Clinic (PHC). Receives: Behavioral: Healthy Living Intervention |
| Enhanced Standard Care Model | Placebo comparator | Patients in control groups will receive an "enhanced standard" care model, which includes providing referrals for mental health needs. Receives: Behavioral: Healthy Living Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of dually diagnosed participants
incidence of patients presenting to Primary Health Clinic (PHC) with a dual diagnosis of depression or anxiety, and diabetes or cardiovascular disease in in the standard versus enhanced screening arms.
Measured: 1 year
anxiety or depression
levels of anxiety or depression reported by participants, depending on initial diagnosis
Measured: 1 year
blood glucose control
for patients presenting with diabetes
Measured: 1 year
blood pressure
for patients presenting with hypertension
Measured: 1 year
cholesterol
for patients presenting with hypercholesterolemia
Measured: 1 year
Secondary outcomes (1)
medication adherence
adherence to medical regimen using a Visual Analog scale. Specific regimen depends on initial diagnosis
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 posted8 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,507 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Maria L Ekstrand, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310932
- Sponsor's protocol ID
- R01MH100311
- Other IDs
- R01MH100311
- Status last verified
- Jun 2020
- First submitted
- 2 Dec 2014
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ekstrand ML, Bharat S, Ramakrishna J, Heylen E. Blame, symbolic stigma and HIV misconceptions are associated with support for coercive measures in urban India. AIDS Behav. 2012 Apr;16(3):700-10. doi: 10.1007/s10461-011-9888-z.
PubMed 21290175Ekstrand ML, Chandy S, Heylen E, Steward W, Singh G. Developing useful highly active antiretroviral therapy adherence measures for India: the Prerana study. J Acquir Immune Defic Syndr. 2010 Mar;53(3):415-6. doi: 10.1097/QAI.0b013e3181ba3e4e. No abstract available.
PubMed 20190588Steward WT, Chandy S, Singh G, Panicker ST, Osmand TA, Heylen E, Ekstrand ML. Depression is not an inevitable outcome of disclosure avoidance: HIV stigma and mental health in a cohort of HIV-infected individuals from Southern India. Psychol Health Med. 2011 Jan;16(1):74-85. doi: 10.1080/13548506.2010.521568.
PubMed 21218366Steward WT, Bharat S, Ramakrishna J, Heylen E, Ekstrand ML. Stigma is associated with delays in seeking care among HIV-infected people in India. J Int Assoc Provid AIDS Care. 2013 Mar-Apr;12(2):103-9. doi: 10.1177/1545109711432315. Epub 2012 Jan 26.
PubMed 22282878Steward WT, Herek GM, Ramakrishna J, Bharat S, Chandy S, Wrubel J, Ekstrand ML. HIV-related stigma: adapting a theoretical framework for use in India. Soc Sci Med. 2008 Oct;67(8):1225-35. doi: 10.1016/j.socscimed.2008.05.032. Epub 2008 Jul 1.
PubMed 18599171Whooley MA. Diagnosis and treatment of depression in adults with comorbid medical conditions: a 52-year-old man with depression. JAMA. 2012 May 2;307(17):1848-57. doi: 10.1001/jama.2012.3466.
PubMed 22550199Wong JM, Na B, Regan MC, Whooley MA. Hostility, health behaviors, and risk of recurrent events in patients with stable coronary heart disease: findings from the Heart and Soul Study. J Am Heart Assoc. 2013 Sep 30;2(5):e000052. doi: 10.1161/JAHA.113.000052.
PubMed 24080907Whooley MA. To screen or not to screen? Depression in patients with cardiovascular disease. J Am Coll Cardiol. 2009 Sep 1;54(10):891-3. doi: 10.1016/j.jacc.2009.05.034.
PubMed 19712797Whooley MA, de Jonge P, Vittinghoff E, Otte C, Moos R, Carney RM, Ali S, Dowray S, Na B, Feldman MD, Schiller NB, Browner WS. Depressive symptoms, health behaviors, and risk of cardiovascular events in patients with coronary heart disease. JAMA. 2008 Nov 26;300(20):2379-88. doi: 10.1001/jama.2008.711.
PubMed 19033588Whooley MA. Depression and cardiovascular disease: healing the broken-hearted. JAMA. 2006 Jun 28;295(24):2874-81. doi: 10.1001/jama.295.24.2874.
PubMed 16804154McManus D, Pipkin SS, Whooley MA. Screening for depression in patients with coronary heart disease (data from the Heart and Soul Study). Am J Cardiol. 2005 Oct 15;96(8):1076-81. doi: 10.1016/j.amjcard.2005.06.037. Epub 2005 Aug 30.
PubMed 16214441Srinivasan K, Joseph W. A study of lifetime prevalence of anxiety and depressive disorders in patients presenting with chest pain to emergency medicine. Gen Hosp Psychiatry. 2004 Nov-Dec;26(6):470-4. doi: 10.1016/j.genhosppsych.2004.06.001.
PubMed 15567213Srinivasan K. "Blues" ain't good for the heart. Indian J Psychiatry. 2011 Jul;53(3):192-4. doi: 10.4103/0019-5545.86797. No abstract available.
PubMed 22135434Srinivasan K, Isaacs AN, Villanueva E, Lucas A, Raghunath D. Medical attribution of common mental disorders in a rural Indian population. Asian J Psychiatr. 2010 Sep;3(3):142-4. doi: 10.1016/j.ajp.2010.07.008. Epub 2010 Sep 6.
PubMed 23051573Mony PK, Jayakumar S. Preparedness for tobacco control among postgraduate residents of a medical college in bangalore. Indian J Community Med. 2011 Apr;36(2):104-8. doi: 10.4103/0970-0218.84127.
PubMed 21976793
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Mental Health Through Integration With Primary Care in Rural Karnataka
- ClinicalTrials.gov ID
- NCT02310932
- Acronym / sponsor ID
- R01MH100311
- Conditions
- Chronic Disease, Depression, Anxiety
- Keywords
- mental health, cardiovascular disease, diabetes, hypertension, high blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,507 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 8 Dec 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.
This cluster Randomized Controlled Trial was designed to implement and evaluate the effects of a multi-level intervention designed to integrate mental health treatment into rural primary health clinics in South India using a collaborative care model.
Detailed description
The prevalence of chronic non-communicable diseases, including cardiovascular disease (CVD), type-2 diabetes (DM), and common mental disorders (CMD), i.e. anxiety \& depression, are increasing worldwide, including in India, where patients with CMD are underserved, especially in rural areas, due to both stigma and lack of trained providers.
Treatment of patients with dual diagnoses involves special challenges and, if left untreated, mental illness can contribute to non-adherence and worsened outcomes.
Similarly, lack of staff training in India's Primary Health Centers (PHC) can result in missed diagnoses, inappropriate treatment, and increased morbidity and suffering. A growing body of research suggests that some of these challenges can be overcome by integrating treatment of patients with co-morbid diagnoses, by using "stepped" or "collaborative" care models. Such integration may also help reduce the stigma of seeking mental health services.
We plan to address this need by implementing and evaluating a multi-level integrated intervention in collaboration with 50 Primary Health Clinics (PHC) in rural Karnataka using a cluster Randomized Controlled Trial (cRCT). Our approach is based on our team's previous clinical and behavioral research in this region and builds on a decade long collaboration between St. John's Research Institute and University of California San Francisco. This study brings together an Indo-US team of scientists and government representatives with expertise in treating and studying mental health, chronic diseases, behavior change, stigma, and in conducting large clinical trials in rural India. It also builds on the work by India's National Rural Health Mission (NRHM), which recently announced that it will add tobacco control to its agenda. If successful, this intervention thus has high potential for scale-up and sustainability.
The proposed intervention is informed by a Social Ecological Paradigm that articulates the relationship between social settings and health behavior. It uses behavior change strategies guided by Cognitive Social Theory. Patients in intervention PHCs will receive integrated collaborative clinic care by their physicians, a nurse case manager and consulting psychiatrists. They will also participate in 12-month community-based "Healthy Living groups," in which cognitive and behavioral strategies are used to target health promoting behaviors, such as increased activity, improved diet, adherence to medical regimens, as well as problem-solving skills, coping skills, and social support. These groups will initially be co-facilitated by a Master's level mental health professional and a trained lay community health outreach worker (ASHA) on a weekly basis for 3 months. During the remaining 9 months, the ASHA will conduct monthly booster sessions focusing on the maintenance of the acquired health-promoting behaviors. Patients in control PHCs will receive an "enhanced standard" care model, which includes providing referrals for mental health needs.
To ensure standardization of study procedures across settings, all control PHC staff will receive basic training in established clinical protocols, plus training in the prescription of anti-depressant medication. While this may represent somewhat of an intervention, we did not consider it ethical to allow clinically depressed patients to be treated with vitamins and anxiolytics, which are currently frequently used in the PHC.
Following a brief start-up phase to adapt measures and finalize protocols, we propose to:
- Use ASHAs to conduct community-based screening of depression, anxiety, DM and CVD risk factors during community health fairs in the catchment areas of 25 PHCs to examine a) whether this increases subsequent diagnoses in the PHC of patients with co-morbid mental health and chronic disease diagnoses and b) whether such patients are as likely to enter and remain in treatment, compared to the standard PHC-based screening.
- Implement and evaluate the effects of providing staff training in the collaborative care model of integrated mental health (depression, anxiety) and cardiovascular disease (hypertension, diabetes, CVD) to intervention PHC staff and compare them to control PHC staff with respect to a) knowledge and clinical skills using clinical patient vignettes, and b) perceived satisfaction reported by clinic patients in intervention and control PHCs.
- Implement and evaluate the effects of our, multi-level integrated clinic and community-based intervention for co-morbid primary care patients compared to the enhanced standard non-integrated treatment services in a cRCT with 50 participating PHC, with regard to both mental health (depression and anxiety) and physical health (diabetes and cardiovascular disease) outcomes at post intervention, 6 month and 12 month follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Living Intervention | Experimental | Behavioral: Healthy Living InterventionThe Healthy Living Intervention group will participate in an intervention designed to improve depression, anxiety, diabetes and CVD outcomes. This will be achieved through a 12 month intervention which consists of participation in healthy living groups and integrated collaborative clinic care at their Primary Health Clinic (PHC). |
| Enhanced Standard Care Model | Placebo comparator | Behavioral: Healthy Living InterventionPatients in control groups will receive an "enhanced standard" care model, which includes providing referrals for mental health needs. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 30 years or older;
- Diagnosed with co-morbid CMD (Depression or Anxiety Disorder) and either
- Able and willing to consent and participate in the intervention and all assessments;
- Able to speak Kannada; and
- Mentally competent to provide consent and answer to study measures and participate in intervention (MMSE score greater than 26).
Key exclusion criteria (5 listed)
- Under 30 years of age;
- Patients who are not diagnosed with co-morbid CMD (Depression or Anxiety Disorder) and either hypertension, diabetes, or diagnosed ischemic heart disease;
- Not mentally competent to provide consent and answer to study measures and participate in intervention (MMSE score > 26).
- Unable to speak Kannada; and
- Participants who do not provide contact information.
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 |
|---|---|---|
| Healthy Living InterventionPatients in the intervention groups will receive integrated collaborative clinic care by their physicians, a nurse case manager and consulting psychiatrists. They will also participate in 12-month community-based "Healthy Living groups," in which cognitive and behavioral strategies are used to target health promoting behaviors, such as increased activity, improved diet, adherence to medical regimens, as well as problem-solving skills, coping skills, and social support. | Behavioural | Enhanced Standard Care Model, Healthy Living Intervention |
Primary outcome
incidence of dually diagnosed participants
Time frame: 1 year
incidence of patients presenting to Primary Health Clinic (PHC) with a dual diagnosis of depression or anxiety, and diabetes or cardiovascular disease in in the standard versus enhanced screening arms.
anxiety or depression
Time frame: 1 year
levels of anxiety or depression reported by participants, depending on initial diagnosis
blood glucose control
Time frame: 1 year
for patients presenting with diabetes
blood pressure
Time frame: 1 year
for patients presenting with hypertension
cholesterol
Time frame: 1 year
for patients presenting with hypercholesterolemia
1 secondary outcome
medication adherence
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 9 Jun 2020.
- Background: PubMed 21290175Ekstrand ML, Bharat S, Ramakrishna J, Heylen E. Blame, symbolic stigma and HIV misconceptions are associated with support for coercive measures in urban India. AIDS Behav. 2012 Apr;16(3):700-10. doi: 10.1007/s10461-011-9888-z.
- Background: PubMed 20190588Ekstrand ML, Chandy S, Heylen E, Steward W, Singh G. Developing useful highly active antiretroviral therapy adherence measures for India: the Prerana study. J Acquir Immune Defic Syndr. 2010 Mar;53(3):415-6. doi: 10.1097/QAI.0b013e3181ba3e4e. No abstract available.
- Background: PubMed 21218366Steward WT, Chandy S, Singh G, Panicker ST, Osmand TA, Heylen E, Ekstrand ML. Depression is not an inevitable outcome of disclosure avoidance: HIV stigma and mental health in a cohort of HIV-infected individuals from Southern India. Psychol Health Med. 2011 Jan;16(1):74-85. doi: 10.1080/13548506.2010.521568.
- Background: PubMed 22282878Steward WT, Bharat S, Ramakrishna J, Heylen E, Ekstrand ML. Stigma is associated with delays in seeking care among HIV-infected people in India. J Int Assoc Provid AIDS Care. 2013 Mar-Apr;12(2):103-9. doi: 10.1177/1545109711432315. Epub 2012 Jan 26.
- Background: PubMed 18599171Steward WT, Herek GM, Ramakrishna J, Bharat S, Chandy S, Wrubel J, Ekstrand ML. HIV-related stigma: adapting a theoretical framework for use in India. Soc Sci Med. 2008 Oct;67(8):1225-35. doi: 10.1016/j.socscimed.2008.05.032. Epub 2008 Jul 1.
- Background: PubMed 22550199Whooley MA. Diagnosis and treatment of depression in adults with comorbid medical conditions: a 52-year-old man with depression. JAMA. 2012 May 2;307(17):1848-57. doi: 10.1001/jama.2012.3466.
- Background: PubMed 24080907Wong JM, Na B, Regan MC, Whooley MA. Hostility, health behaviors, and risk of recurrent events in patients with stable coronary heart disease: findings from the Heart and Soul Study. J Am Heart Assoc. 2013 Sep 30;2(5):e000052. doi: 10.1161/JAHA.113.000052.
- Background: PubMed 19712797Whooley MA. To screen or not to screen? Depression in patients with cardiovascular disease. J Am Coll Cardiol. 2009 Sep 1;54(10):891-3. doi: 10.1016/j.jacc.2009.05.034.
- Background: PubMed 19033588Whooley MA, de Jonge P, Vittinghoff E, Otte C, Moos R, Carney RM, Ali S, Dowray S, Na B, Feldman MD, Schiller NB, Browner WS. Depressive symptoms, health behaviors, and risk of cardiovascular events in patients with coronary heart disease. JAMA. 2008 Nov 26;300(20):2379-88. doi: 10.1001/jama.2008.711.
- Background: PubMed 16804154Whooley MA. Depression and cardiovascular disease: healing the broken-hearted. JAMA. 2006 Jun 28;295(24):2874-81. doi: 10.1001/jama.295.24.2874.
- Background: PubMed 16214441McManus D, Pipkin SS, Whooley MA. Screening for depression in patients with coronary heart disease (data from the Heart and Soul Study). Am J Cardiol. 2005 Oct 15;96(8):1076-81. doi: 10.1016/j.amjcard.2005.06.037. Epub 2005 Aug 30.
- Background: PubMed 15567213Srinivasan K, Joseph W. A study of lifetime prevalence of anxiety and depressive disorders in patients presenting with chest pain to emergency medicine. Gen Hosp Psychiatry. 2004 Nov-Dec;26(6):470-4. doi: 10.1016/j.genhosppsych.2004.06.001.
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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.
Maria L Ekstrand, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Living Intervention in people with Chronic Disease and Depression, run by University of California, San Francisco at 1 site 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 5 inclusion and 5 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 9 Jun 2020. 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 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. Some participants in this study may receive a placebo. 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?
incidence of dually diagnosed participants (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02310932, which also lists 20 linked publications.
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 9 Jun 2020.