Improving Mental Health Through Integration With Primary Care in Rural Karnataka

NCT02310932 | Completed DMC

• 1 other identifier: R01MH100311
• Study Type: interventional
• Target: 2,507
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Disease; Depression; Anxiety

Keywords

mental health; cardiovascular disease; diabetes; hypertension; high blood pressure

Outcome Measures

Primary Outcomes (5)

• 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.

  1 year

• anxiety or depression

  levels of anxiety or depression reported by participants, depending on initial diagnosis

  1 year

• blood glucose control

  for patients presenting with diabetes

  1 year

• blood pressure

  for patients presenting with hypertension

  1 year

• cholesterol

  for patients presenting with hypercholesterolemia

  1 year

Secondary Outcomes (1)

• medication adherence

  1 year

Study Arms (2)

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).

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.

Behavioral: Healthy Living Intervention

Interventions

Healthy Living Intervention BEHAVIORAL

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.

Enhanced Standard Care Model; Healthy Living Intervention

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

St. John & Research Institute/St John & Medical College & Hospital

Bangalore, Karnataka, 560 034, India

Location

Related Publications (20)

• 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.

  PMID: 21290175 BACKGROUND

• Ekstrand 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.

  PMID: 20190588 BACKGROUND

• Steward 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.

  PMID: 21218366 BACKGROUND

• Steward 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.

  PMID: 22282878 BACKGROUND

• Steward 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.

  PMID: 18599171 BACKGROUND

• Whooley 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.

  PMID: 22550199 BACKGROUND

• Wong 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.

  PMID: 24080907 BACKGROUND

• Whooley 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.

  PMID: 19712797 BACKGROUND

• Whooley 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.

  PMID: 19033588 BACKGROUND

• Whooley MA. Depression and cardiovascular disease: healing the broken-hearted. JAMA. 2006 Jun 28;295(24):2874-81. doi: 10.1001/jama.295.24.2874.

  PMID: 16804154 BACKGROUND

• McManus 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.

  PMID: 16214441 BACKGROUND

• Srinivasan 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.

  PMID: 15567213 BACKGROUND

• Srinivasan 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.

  PMID: 22135434 BACKGROUND

• Srinivasan 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.

  PMID: 23051573 BACKGROUND

• Mony 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.

  PMID: 21976793 BACKGROUND

• Mony PK, Vaz M. A qualitative inquiry into the application of verbal autopsy for a mortality surveillance system in a rural community of southern India. World Health Popul. 2011;13(1):30-9. doi: 10.12927/whp.2011.22514.

  PMID: 22543418 BACKGROUND

• Salazar LJ, Hegde D, Srinivasan K, Heylen E, Ekstrand ML. Correlates of disability among primary care patients with common mental disorders and chronic medical conditions- a cross-sectional study from rural South India. Soc Psychiatry Psychiatr Epidemiol. 2025 Apr;60(4):859-868. doi: 10.1007/s00127-024-02727-w. Epub 2024 Jul 23.

  PMID: 39044019 DERIVED

• Srinivasan K, Heylen E, Johnson Pradeep R, Mony PK, Ekstrand ML. Collaborative care compared to enhanced standard treatment of depression with co-morbid medical conditions among patients from rural South India: a cluster randomized controlled trial (HOPE Study). BMC Psychiatry. 2022 Jun 13;22(1):394. doi: 10.1186/s12888-022-04000-3.

  PMID: 35698087 DERIVED

• Thomas S, Srinivasan K, Heylen E, Ekstrand ML. Correlates of social support in individuals with a diagnosis of common mental disorders and non communicable medical diseases in rural South India. Soc Psychiatry Psychiatr Epidemiol. 2021 Sep;56(9):1623-1631. doi: 10.1007/s00127-020-01997-4. Epub 2021 Jan 1.

  PMID: 33386410 DERIVED

• Srinivasan K, Mazur A, Mony PK, Whooley M, Ekstrand ML. Improving mental health through integration with primary care in rural Karnataka: study protocol of a cluster randomized control trial. BMC Fam Pract. 2018 Sep 11;19(1):158. doi: 10.1186/s12875-018-0845-z.

  PMID: 30205830 DERIVED

MeSH Terms

Conditions

Chronic Disease; Depression; Anxiety Disorders; Psychological Well-Being; Cardiovascular Diseases; Diabetes Mellitus; Hypertension

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases

Study Officials

• Maria L Ekstrand, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: December 8, 2014
• Study Start: February 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 9, 2020

Record last verified: 2020-06

Locations

IN (1)