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Stress Management Among Latinos With Type 2 Diabetes

Stress Management Among Latinos With Type 2 Diabetes Mellitus

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01578096
Acronym
CALMS-D
Enrollment
107
Registered
2012-04-16
Start date
2012-05-31
Completion date
2015-06-30
Last updated
2020-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 Diabetes

Brief summary

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.

Interventions

BEHAVIORALstress 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.

Sponsors

Hartford Hospital
CollaboratorOTHER
UConn Health
CollaboratorOTHER
Hispanic Health Council, Inc.
CollaboratorOTHER
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Hemoglobin A1cBaselineBlood will be drawn from participants and hemoglobin A1c levels will be measured

Secondary

MeasureTime frameDescription
Diabetes specific distressBaselineParticipants will be asked questions assessing their perspective of emotional distress from living with diabetes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026