Stress Management Among Latinos With Type 2 Diabetes (CALMS-D)
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ClinicalTrials.gov Identifier: NCT01578096 |
Recruitment Status :
Completed
First Posted : April 16, 2012
Last Update Posted : April 1, 2020
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The primary aims of this study are to:
- Tailor a diabetes stress management intervention for delivery by community health workers (CHWs) serving an urban Latino population.
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Investigate the efficacy of the stress management intervention on glycemic control.
Secondary aims of this study are to:
- 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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 | Behavioral: stress management | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 107 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Stress Management Among Latinos With Type 2 Diabetes Mellitus |
Study Start Date : | May 2012 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | June 2015 |

Arm | Intervention/treatment |
---|---|
No Intervention: Diabetes education
Group-based diabetes education delivered to participants through community health workers
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Experimental: Diabetes education plus stress management
Group-based diabetes education plus stress management delivered to participants through community health workers
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Behavioral: stress management
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. |
- Hemoglobin A1c [ Time Frame: Baseline ]Blood will be drawn from participants and hemoglobin A1c levels will be measured
- Hemoglobin A1c [ Time Frame: 9 weeks ]Blood will be drawn from participants and hemoglobin A1c levels will be measured
- Hemoglobin A1c [ Time Frame: 6 months ]Blood will be drawn from participants and hemoglobin A1c levels will be measured
- Diabetes specific distress [ Time Frame: Baseline ]Participants will be asked questions assessing their perspective of emotional distress from living with diabetes
- Diabetes specific distress [ Time Frame: 9 weeks ]Participants will be asked questions assessing their perspective of emotional distress from living with diabetes
- Diabetes specific distress [ Time Frame: 6 months ]Participants will be asked questions assessing their perspective of emotional distress from living with diabetes

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578096
United States, Connecticut | |
Yale University | |
New Haven, Connecticut, United States |
Principal Investigator: | Rafael Pérez-Escamilla, Ph.D. | Yale University |
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT01578096 |
Other Study ID Numbers: |
R01MD005879 ( U.S. NIH Grant/Contract ) R01MD005879 ( U.S. NIH Grant/Contract ) |
First Posted: | April 16, 2012 Key Record Dates |
Last Update Posted: | April 1, 2020 |
Last Verified: | March 2020 |
Type 2 Diabetes |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |