HealthyNCT00896844
A Trial on the Effect of Emotional Disclosure of Traumatic Life Events on Physical Health
A study testing emotional disclosure in people with Healthy, run by University Hospital Birmingham at 1 site in United Kingdom.
Trial summary
This is a randomized, controlled trial on the effect of emotional disclosure of traumatic life events on physical health. The hypothesis is that expression of emotions could possibly improve physical health. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- emotional disclosure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2001to May 2004
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy
Who cannot join
- any mental or physical illnesses in the last three months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Birmingham
Birmingham, West Midlands, B15 2TT
About this study
Official title: A Randomised Controlled Trial on the Effect of Emotional Disclosure of Traumatic Life Events on Physical Health
This is a randomized, controlled trial on the effect of emotional disclosure of traumatic life events on physical health. The hypothesis is that expression of emotions could possibly improve physical health.
- Conditions
- Healthy
- Being tested
- emotional disclosure, placebo writing
- Keywords
- emotional disclosure, expressive writing, students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emotional disclosureBehavioural
writing about emotional events from the past
placebo writingBehavioural
writing about how they spent their time the previous day
| Study group | Role | What they receive |
|---|---|---|
| emotional disclosure | Experimental | writing about emotional events from the past Receives: Behavioral: emotional disclosure |
| placebo writing | Placebo comparator | writing about how they spent their time the previous day Receives: Behavioral: placebo writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
health centre visits
Measured: within 3 months
Secondary outcomes (1)
respiratory infections
Measured: within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startSep 2001
- Primary completionMay 2004
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896844
- Sponsor's protocol ID
- 1-Meads
- Status last verified
- May 2009
- First submitted
- 11 May 2009
- Last updated
- 12 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial on the Effect of Emotional Disclosure of Traumatic Life Events on Physical Health
- ClinicalTrials.gov ID
- NCT00896844
- Acronym / sponsor ID
- 1-Meads
- Conditions
- Healthy
- Keywords
- emotional disclosure, expressive writing, students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital BirminghamUniversity, hospital or other
- Collaborators
- University of Birmingham
- Study start
- Sep 2001
- Primary completion
- May 2004 (actual)
- Study completion
- May 2004 (actual)
- First posted
- 12 May 2009 (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 is a randomized, controlled trial on the effect of emotional disclosure of traumatic life events on physical health. The hypothesis is that expression of emotions could possibly improve physical health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| emotional disclosure | Experimental | Behavioral: emotional disclosurewriting about emotional events from the past |
| placebo writing | Placebo comparator | Behavioral: placebo writingwriting about how they spent their time the previous day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy
Key exclusion criteria (1 listed)
- any mental or physical illnesses in the last three months
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 |
|---|---|---|
| emotional disclosurewriting about emotional events from the past | Behavioural | emotional disclosure |
| placebo writingwriting about how they spent their time the previous day | Behavioural | placebo writing |
Primary outcome
health centre visits
Time frame: within 3 months
1 secondary outcome
respiratory infections
Time frame: within 3 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 12 May 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing emotional disclosure in people with Healthy, run by University Hospital Birmingham at 1 site in United Kingdom.
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 1 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 12 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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.
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?
health centre visits (time frame: within 3 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 12 May 2009.