Expressive Writing for Reducing Stress and Diabetic Symptoms in Diabetes Patients

Phase 2

Completed

• Conditions: Diabetes Mellitus; Stress; Depression
• Interventions: Behavioral: Neutral writing; Behavioral: Expressive writing

• Registration Number: NCT00233142
• Lead Sponsor: Syracuse University

Brief Summary

This study will determine whether the psychological benefits of expressive writing extend to diabetic patients, how long the benefits will last, and whether additional expressive writing "booster" sessions will lead to greater and more sustained improvement in diabetes symptoms and well-being.

Detailed Description

Diabetes is one of the leading causes of blindness, kidney failure, and nontraumatic lower extremity amputation in the United States. Conditions such as stress and depression have been shown to worsen diabetic symptoms. Data indicate that expressive writing (an activity during which individuals deal with stressful experiences by writing about them on paper) has beneficial effects on psychological and physiological outcomes. This study will determine whether diabetes patients can benefit from expressive writing. This study will also determine the duration of the benefits and the effectiveness of booster sessions in improving their diabetic symptoms.

Participants will be randomly assigned to engage in expressive writing or neutral writing for 18 months. Participants in the expressive writing group will write about traumatic or stressful events; participants in the neutral writing group will write about neutral topics that do not affect them emotionally. Some participants in the expressive writing group will receive an additional 4 months of booster sessions of expressive writing. All participants will undergo interviews, blood collection, physical exams and complete clinical scales on their disease status, quality of life, and psychological well-being; these assessments will occur at study entry, every 4 months during the study, and at the end of the study.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-10-03
• Study First Posted: 2005-10-05
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2009-11
• Last Update Submitted: 2016-04-13
• Last Update Posted: 2016-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

Inclusion Criteria

• Diagnosis of diabetes mellitus made after age 24

Exclusion Criteria

• Diabetes-related emergency room visit within 3 months prior to study entry
• Use of psychiatric medication within 3 months prior to study entry
• Visual or manual limitations that preclude reading and writing
• Use of insulin within the first year of diabetes diagnosis
• Pregnancy or plan to become pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neutral writing	Neutral writing	Non-expressive writing
Expressive writing	Expressive writing	Expressive writing

Primary Outcome Measures

Name	Time	Method
hemoglobin A1C (indicator of blood glucose)	baseline, 4 months, 8 months, 12 months, and 16 months

Secondary Outcome Measures

Name	Time	Method
depression	baseline, 4 months, 8 months, 12 months, and 16 months
Diabetes symptoms	baseline, 4 months, 8 months, 12 months, and 16 months
quality of life	baseline, 4 months, 8 months, 12 months, and 16 months
cognitive function	baseline, 4 months, 8 months, 12 months, and 16 months
stress levels	baseline, 4 months, 8 months, 12 months, and 16 months

Trial Locations

Locations (4)

State University of New York Medical University; 🇺🇸 Syracuse, New York, United States

Pennsylvania State University; 🇺🇸 University Park, Pennsylvania, United States

Syracuse University; 🇺🇸 Syracuse, New York, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States