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Expressive Writing for Reducing Stress and Diabetic Symptoms in Diabetes Patients

Expressive Writing: Complementary Treatment for Diabetes

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00233142
Enrollment
187
Registered
2005-10-05
Start date
2005-09-30
Completion date
2009-02-28
Last updated
2016-04-15

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

Conditions

Depression, Diabetes Mellitus, Stress

Keywords

Diabetes, Emotions, Blood glucose, Expressive Writing

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.

Interventions

BEHAVIORALExpressive writing

Writing as therapeutic intervention

BEHAVIORALNeutral writing

Non-expressive writing

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
Syracuse University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Diabetes symptomsbaseline, 4 months, 8 months, 12 months, and 16 months
stress levelsbaseline, 4 months, 8 months, 12 months, and 16 months
depressionbaseline, 4 months, 8 months, 12 months, and 16 months
cognitive functionbaseline, 4 months, 8 months, 12 months, and 16 months
quality of lifebaseline, 4 months, 8 months, 12 months, and 16 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026