Expressive Writing for Reducing Stress and Diabetic Sympt... | NCT00233142

Studies
Expressive Writing for Reducing Stress and Diabetic Symptoms in Diabetes Patients

NCT00233142

Sponsor

Syracuse University

Status

Completed

Last Update Posted

Apr 15, 2016Estimated

Enrollment

187Actual

Phase

Phase 2

Conditions

Diabetes Mellitus
Stress
Depression

Interventions

Expressive writing
Neutral writing

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01AT002477	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Feb 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Oct 3, 2005

First Posted Date

Oct 5, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2016

Last Update Posted Date

Apr 15, 2016Estimated

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

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

187Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Expressive writing	Experimental	Expressive writing	Behavioral: Expressive writing
Neutral writing	Sham Comparator	Non-expressive writing	Behavioral: Neutral writing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Expressive writing	Behavioral	Writing as therapeutic intervention	Expressive writing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hemoglobin A1C (indicator of blood glucose)		baseline, 4 months, 8 months, 12 months, and 16 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joshua M. Smyth, PhD	Syracuse University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
State University of New York Medical University		Syracuse	New York	13244	United States
Syracuse University

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D003863	Depression

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

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