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OpenTrials
Completed

NCT Number: NCT01578096

Stress Management Among Latinos With Type 2 Diabetes

The primary aims of this study are to:

1. Tailor a diabetes stress management intervention for delivery by community health workers (CHWs) serving an urban Latino population. 2. Investigate the efficacy of the stress management intervention on glycemic control.

Secondary aims of this study are to: 3. Investigate the efficacy of the stress management intervention on stress hormones, psychosocial functioning, and stress-glucose reactivity.

Study hypothesis:

A CHW-led group-based diabetes education model enhanced with stress management education will improve glycemic control more than CHW-led group-based diabetes education alone.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Latinos age 18 or older that are ambulatory
  • Spanish speaking
  • Diagnosed with type 2 diabetes for at least 1 year
  • Hemoglobin A1c levels greater than 7.0

Exclusion criteria

  • Medical instability or medical treatment requiring inpatient care
  • Diagnoses of bipolar disorder or thought disorder (or taking medications prescribed for either); current substance abuse or dependence disorder
  • Current suicidality or history of suicide attempt
  • History of psychiatric hospitalization
  • Taking antidepressant medications prescribed for the treatment of depression accompanied by either a) changes to the antidepressant regimen within previous 6 weeks, or b) anticipated changes to the regimen during period of study. Such patients will be deferred and re-evaluated for eligibility after 6 months

Treatment and study plan

Stress Management

Behavioral

The study is a randomized, controlled,single-site, parallel group clinical trial comparing the effectiveness of CHW led diabetes education with CHW led diabetes education plus CHW led stress management in Latinos with Type 2 Diabetes.

Primary outcomes

  1. Hemoglobin A1c

    Time frame: Baseline

    Blood will be drawn from participants and hemoglobin A1c levels will be measured

  2. Hemoglobin A1c

    Time frame: 9 weeks

    Blood will be drawn from participants and hemoglobin A1c levels will be measured

  3. Hemoglobin A1c

    Time frame: 6 months

    Blood will be drawn from participants and hemoglobin A1c levels will be measured

Secondary outcomes

  1. Diabetes specific distress

    Time frame: Baseline

    Participants will be asked questions assessing their perspective of emotional distress from living with diabetes

  2. Diabetes specific distress

    Time frame: 9 weeks

    Participants will be asked questions assessing their perspective of emotional distress from living with diabetes

  3. Diabetes specific distress

    Time frame: 6 months

    Participants will be asked questions assessing their perspective of emotional distress from living with diabetes

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Hartford Hospital
  • Hispanic Health Council, Inc.
  • National Institute on Minority Health and Health Disparities (NIMHD)
  • UConn Health

Registry information

Official study title

Stress Management Among Latinos With Type 2 Diabetes Mellitus

Acronym: CALMS-D

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Apr 16, 2012
Registry last updated
Apr 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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