Expressive Writing for Reducing Stress and Diabetic Symptoms in Diabetes Patients

Sponsor

Syracuse University (Other)

Overall Status

Completed

CT.gov ID

NCT00233142

Collaborator

National Center for Complementary and Integrative Health (NCCIH) (NIH)

187

Enrollment

Locations

Arms

Duration (Months)

46.8

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Stress Depression	Behavioral: Expressive writing Behavioral: Neutral writing	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

187 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Expressive Writing: Complementary Treatment for Diabetes

Study Start Date :

Sep 1, 2005

Actual Primary Completion Date :

Feb 1, 2009

Actual Study Completion Date :

Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Expressive writing Expressive writing	Behavioral: Expressive writing Writing as therapeutic intervention
Sham Comparator: Neutral writing Non-expressive writing	Behavioral: Neutral writing Non-expressive writing

Arm

Intervention/Treatment

Experimental: Expressive writing

Expressive writing

Behavioral: Expressive writing

Writing as therapeutic intervention

Sham Comparator: Neutral writing

Non-expressive writing

Behavioral: Neutral writing

Non-expressive writing

Outcome Measures

Primary Outcome Measures

hemoglobin A1C (indicator of blood glucose) [baseline, 4 months, 8 months, 12 months, and 16 months]

Secondary Outcome Measures

Diabetes symptoms [baseline, 4 months, 8 months, 12 months, and 16 months]
stress levels [baseline, 4 months, 8 months, 12 months, and 16 months]
depression [baseline, 4 months, 8 months, 12 months, and 16 months]
cognitive function [baseline, 4 months, 8 months, 12 months, and 16 months]
quality of life [baseline, 4 months, 8 months, 12 months, and 16 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	State University of New York Medical University	Syracuse	New York	United States	13244
2	Syracuse University	Syracuse	New York	United States	13244
3	Pennsylvania State University	University Park	Pennsylvania	United States	16802
4	Vanderbilt University	Nashville	Tennessee	United States	37235