HIV InfectionsNCT00067704
Emotional Disclosure in HIV
A study testing Trauma writing and Writing about daily events in people with HIV Infections, run by University of Miami at 1 site in United States.
Trial summary
The specific objective of this study are to examine whether or not a treatment aimed at emotional disclosure may have beneficial psychological, health and immune effects for HIV infected individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Trauma writing and Writing about daily events
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 283 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Nov 2012
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years of age inclusive
- At least 8 years of formal education
- Literate
- Fluent in English
- All of the following three must apply:
- No active Category C HIV AIDS-defining symptoms
- CD4 T-lymphocyte count between 150-499
- Viral load >1000
Who cannot join
- Less than 8 years formal education
- Illiterate or non-English speaking
- Active systemic diseases that would interfere with participation
- Current alcohol or substance dependence
- Planned change in HIV medication in the next 6 months, or recent change in past 2 months
- Introduction of antidepressant medication within 30 days of study start
Show all 9Show fewer
- Current psychological counseling, cognitive behavior therapy, support group or other psychological therapy, or plans to start any of the above
- Diagnosis of PTSD or major depression
- Unable to attend at least 4 treatment sessions
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Dept. of Psychology & Behavioral Medicine
Coral Gables, Florida, 33124-2070
About this study
Official title: Efficacy of an Emotional Disclosure Intervention in HIV
The specific objective of this study are to examine whether or not a treatment aimed at emotional disclosure may have beneficial psychological, health and immune effects for HIV infected individuals. The goal of the current study is to test the efficacy of emotional disclosure through writing in patients with HIV infection. We will compare emotional disclosure through writing about traumatic experiences (experimental intervention) to a control intervention (writing about emotionally neutral topics). [Note that HIV RNA viral load, CD4 T cells, urinary cortisol, health related dysfunction, psychological distress, and medication adherence are the 6 primary outcome variables.
- Conditions
- HIV Infections
- Being tested
- Trauma writing, Writing about daily events
- Keywords
- Complementary Therapies
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma writingBehavioural
Writing about daily eventsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Trauma writing | Experimental | Four sessions of writing about traumatic experiences. Receives: Behavioral: Trauma writing |
| Writing about daily events | Sham comparator | Four sessions of writing about their daily experiences. Receives: Behavioral: Writing about daily events |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in psychological distress
Measured: 1 year
Secondary outcomes (2)
Increase in CD4 T-lymphocytes
Measured: 1 year
Decrease in the number of HIV symptoms
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2003 (estimated)
- Study startFeb 2004
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Gail Ironson, University of Miami
- Investigators
- Gail Ironson, MD, Principal investigator, University of Miami Dept. of Psychology & Behavioral Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067704
- Sponsor's protocol ID
- 20020511
- Other IDs
- R01AT002035
- Status last verified
- Oct 2015
- First submitted
- 25 Aug 2003
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Emotional Disclosure Intervention in HIV
- ClinicalTrials.gov ID
- NCT00067704
- Acronym / sponsor ID
- 20020511
- Conditions
- HIV Infections
- Keywords
- Complementary Therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Feb 2004
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 27 Aug 2003 (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.
The specific objective of this study are to examine whether or not a treatment aimed at emotional disclosure may have beneficial psychological, health and immune effects for HIV infected individuals. The goal of the current study is to test the efficacy of emotional disclosure through writing in patients with HIV infection. We will compare emotional disclosure through writing about traumatic experiences (experimental intervention) to a control intervention (writing about emotionally neutral topics). [Note that HIV RNA viral load, CD4 T cells, urinary cortisol, health related dysfunction, psychological distress, and medication adherence are the 6 primary outcome variables.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trauma writing | Experimental | Behavioral: Trauma writingFour sessions of writing about traumatic experiences. |
| Writing about daily events | Sham comparator | Behavioral: Writing about daily eventsFour sessions of writing about their daily experiences. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-65 years of age inclusive
- At least 8 years of formal education
- Literate
- Fluent in English
- No active Category C HIV AIDS-defining symptoms
Key exclusion criteria (9 listed)
- Less than 8 years formal education
- Illiterate or non-English speaking
- Active systemic diseases that would interfere with participation
- Current alcohol or substance dependence
- Planned change in HIV medication in the next 6 months, or recent change in past 2 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 |
|---|---|---|
| Trauma writing | Behavioural | Trauma writing |
| Writing about daily events | Behavioural | Writing about daily events |
Primary outcome
Decrease in psychological distress
Time frame: 1 year
2 secondary outcomes
Increase in CD4 T-lymphocytes
Time frame: 1 year
Decrease in the number of HIV symptoms
Time frame: 1 year
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 14 Oct 2015.
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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.
Gail Ironson, MD principal investigator
University of Miami Dept. of Psychology & Behavioral Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma writing and Writing about daily events in people with HIV Infections, run by University of Miami at 1 site 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 8 inclusion and 9 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 14 Oct 2015. 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 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.
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?
Decrease in psychological distress (time frame: 1 year). 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 14 Oct 2015; AzTrials last refreshed its copy on 3 Nov 2026.