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CALMS-D: Stress Management Among Latinos With Type 2 Diabetes

Sponsor
Yale University (Other)
Overall Status
Completed
CT.gov ID
NCT01578096
Collaborator
Hartford Hospital (Other), UConn Health (Other), Hispanic Health Council, Inc. (Other), National Institute on Minority Health and Health Disparities (NIMHD) (NIH)
107
Enrollment
1
Location
2
Arms
37
Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

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:
  1. 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
  • Behavioral: stress management
 N/A

Study Design

Study Type:
Interventional
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 1, 2012
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Diabetes education

Group-based diabetes education delivered to participants through community health workers
Experimental: Diabetes education plus stress management

Group-based diabetes education plus stress management delivered to participants through community health workers

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.

Outcome Measures

Primary Outcome Measures

  1. Hemoglobin A1c [Baseline]

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

  2. Hemoglobin A1c [9 weeks]

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

  3. Hemoglobin A1c [6 months]

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

Secondary Outcome Measures

  1. Diabetes specific distress [Baseline]

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

  2. Diabetes specific distress [9 weeks]

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

  3. Diabetes specific distress [6 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yale University New Haven Connecticut United States

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Rafael Pérez-Escamilla, Ph.D., Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT01578096
Other Study ID Numbers:
  • R01MD005879
  • R01MD005879
First Posted:
Apr 16, 2012
Last Update Posted:
Apr 1, 2020
Last Verified:
Mar 1, 2020
Keywords provided by Yale University
Type 2 Diabetes
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Apr 1, 2020