Diabetes MellitusPhase 2NCT00233142
Expressive Writing for Reducing Stress and Diabetic Symptoms in Diabetes Patients
A Phase 2 study testing Expressive writing and Neutral writing in people with Diabetes Mellitus and Stress, run by Syracuse University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Stress, Depression
- What is being tested?
- Expressive writing and Neutral writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 187 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2005to Feb 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of diabetes mellitus made after age 24
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Vanderbilt University
Nashville, Tennessee, 37235
State University of New York Medical University
Syracuse, New York, 13244
Syracuse University
Syracuse, New York, 13244
Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
Official title: Expressive Writing: Complementary Treatment for Diabetes
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Stress, Depression
- Being tested
- Expressive writing, Neutral writing
- Keywords
- Diabetes, Emotions, Blood glucose, Expressive Writing
- Medical subject headings
- Diabetes Mellitus, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive writingBehavioural
Writing as therapeutic intervention
Neutral writingBehavioural
Non-expressive writing
| Study group | Role | What they receive |
|---|---|---|
| Expressive writing | Experimental | Expressive writing Receives: Behavioral: Expressive writing |
| Neutral writing | Sham comparator | Non-expressive writing Receives: Behavioral: Neutral writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin A1C (indicator of blood glucose)
Measured: baseline, 4 months, 8 months, 12 months, and 16 months
Secondary outcomes (5)
Diabetes symptoms
Measured: baseline, 4 months, 8 months, 12 months, and 16 months
stress levels
Measured: baseline, 4 months, 8 months, 12 months, and 16 months
depression
Measured: baseline, 4 months, 8 months, 12 months, and 16 months
cognitive function
Measured: baseline, 4 months, 8 months, 12 months, and 16 months
quality of life
Measured: baseline, 4 months, 8 months, 12 months, and 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2005 (estimated)
- Study startSep 2005
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syracuse University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Joshua M. Smyth, PhD, Principal investigator, Syracuse University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233142
- Sponsor's protocol ID
- R01AT002477
- Other IDs
- R01AT002477
- Status last verified
- Nov 2009
- First submitted
- 13 Sep 2005
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expressive Writing: Complementary Treatment for Diabetes
- ClinicalTrials.gov ID
- NCT00233142
- Acronym / sponsor ID
- R01AT002477
- Conditions
- Diabetes Mellitus, Stress, Depression
- Keywords
- Diabetes, Emotions, Blood glucose, Expressive Writing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Syracuse UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Sep 2005
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 5 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expressive writing | Experimental | Behavioral: Expressive writingExpressive writing |
| Neutral writing | Sham comparator | Behavioral: Neutral writingNon-expressive writing |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of diabetes mellitus made after age 24
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expressive writingWriting as therapeutic intervention | Behavioural | Expressive writing |
| Neutral writingNon-expressive writing | Behavioural | Neutral writing |
Primary outcome
hemoglobin A1C (indicator of blood glucose)
Time frame: baseline, 4 months, 8 months, 12 months, and 16 months
5 secondary outcomes
Diabetes symptoms
Time frame: baseline, 4 months, 8 months, 12 months, and 16 months
stress levels
Time frame: baseline, 4 months, 8 months, 12 months, and 16 months
depression
Time frame: baseline, 4 months, 8 months, 12 months, and 16 months
cognitive function
Time frame: baseline, 4 months, 8 months, 12 months, and 16 months
quality of life
Time frame: baseline, 4 months, 8 months, 12 months, and 16 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua M. Smyth, PhD principal investigator
Syracuse University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Expressive writing and Neutral writing in people with Diabetes Mellitus and Stress, run by Syracuse University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemoglobin A1C (indicator of blood glucose) (time frame: baseline, 4 months, 8 months, 12 months, and 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2016.