Stress Disorders, Post-TraumaticNCT00611338
Efficacy of Group Intervention to Reduce Stress Symptoms
A study testing HIV Skills-based Prevention in people with Stress Disorders, Post-Traumatic and HIV Infections, run by Stanford University at 1 site in United States.
Trial summary
This research study will examine the usefulness of groups in reducing stress and helping individuals with HIV to stay healthy and avoid problems associated with sexually transmitted diseases. We hope to discover whether being in a group is effective in reducing stress-related symptoms and promoting healthy behaviors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic, HIV Infections
- What is being tested?
- HIV Skills-based Prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2006to 31 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:Must be 18 years or older, must be HIV-positive, report engaging in behavior that could put them at risk for HIV transmission in the past three months, report experiencing one or more trauma-related symptoms within the past three months.
Exclusion Criteria:Exclusion criteria include the presence of gross cognitive impairment, dementia, acute psychosis, or severe physical impairment that would preclude adequate comprehension of assessment material and participation in small group intervention.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
This research study will examine the usefulness of groups in reducing stress and helping individuals with HIV to stay healthy and avoid problems associated with sexually transmitted diseases. We hope to discover whether being in a group is effective in reducing stress-related symptoms and promoting healthy behaviors.
Read the detailed description
This is a risk reduction intervention for adults who are living with HIV, are experiencing trauma-related stress symptoms, and are at risk for HIV transmission. By first treating trauma symptoms, the effects of a skills-building HIV risk reduction intervention for adults experiencing trauma-related symptoms such as hyperarousal, dissociation, and avoidance will be enhanced. This is based on a model the proposes trauma-related symptoms have direct effects on HIV risk behavior. Therefore, the successful treatment of trauma-related symptoms will facilitate HIV risk behavior change.
- Conditions
- Stress Disorders, Post-Traumatic, HIV Infections
- Being tested
- HIV Skills-based Prevention
- Keywords
- Complementary Therapies
- Medical subject headings
- Stress Disorders, Post-Traumatic, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV Skills-based PreventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care, Wait-List Control | Active comparator | Participants received standard medical care, which in most clinics included informational brochures provided by physicians and clinic staff. Participants were given HIV prevention information and materials in English and Spanish and were provided referrals for services. Each individual completed assessments at immediate post intervention, 3-, 6-, and 12- months. At the end of the 12-month assessment, the wait-list control participants participated in the Trauma + HIV group arm. Receives: Behavioral: HIV Skills-based Prevention |
| HIV Prevention | Active comparator | Eight, 90 minute group sessions. Three of the sessions focused on health education (e.g., medication adherence, nutrition, exercise) and five focused on HIV prevention skills (e.g., condom skills, communication, social support). Each individual completed assessments at immediate post intervention, 3-, 6-, and 12- months. At the end of the 12-month assessment, the participants in this arm were given the option to receive the 3 trauma-focused sessions from the Trauma + HIV group arm. Receives: Behavioral: HIV Skills-based Prevention |
| HIV Prevention plus Trauma | Active comparator | The same format as the HIV Prevention arm with eight, 90 minute group sessions. The participants received the same five HIV prevention skills sessions along with three sessions that focused on reducing trauma-related stress (e.g., breathing training, relaxation exercises, grounding exercises, coping, trauma-related triggers). Each individual completed assessments at immediate post intervention, 3-, 6-, and 12- months. Receives: Behavioral: HIV Skills-based Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if decreasing trauma-related stress symptoms improves HIV risk reduction behavior above a standard HIV risk reduction intervention alone post -intervention 3, 6, and 12 months after the group intervention sessions.
unprotected insertive and receptive sexual intercourse
Measured: immediate post intervention, 3 months, 6 months, and 12 months
To determine if decreasing trauma-related stress symptoms improves HIV risk reduction behavior above a standard HIV risk reduction intervention alone
Mediation effect on trauma symptoms on HIV-related risk behavior
Measured: immediate post intervention, 3 months, 6 months, and 12 months
Secondary outcomes (1)
To determine whether key variables moderate the intervention's effects.
Gender, age, ethnicity, or psychological distress (e.g. , depression, anxiety) may interact with the intervention to affect risky sexual or drug-related behavior.
Measured: immediate post intervention, 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study start1 Aug 2006
- Primary completion31 Jul 2012
- Study completion31 Jul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheryl Gore-Felton, Stanford University
- Investigators
- Cheryl Gore-Felton Ph.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611338
- Sponsor's protocol ID
- SU-12192007-944
- Status last verified
- Mar 2020
- First submitted
- 25 Jan 2008
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Group Intervention to Reduce Stress Symptoms
- ClinicalTrials.gov ID
- NCT00611338
- Acronym / sponsor ID
- SU-12192007-944
- Conditions
- Stress Disorders, Post-Traumatic, HIV Infections
- Keywords
- Complementary Therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Aug 2006 (actual)
- Primary completion
- 31 Jul 2012 (actual)
- Study completion
- 31 Jul 2012 (actual)
- First posted
- 8 Feb 2008 (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 research study will examine the usefulness of groups in reducing stress and helping individuals with HIV to stay healthy and avoid problems associated with sexually transmitted diseases. We hope to discover whether being in a group is effective in reducing stress-related symptoms and promoting healthy behaviors.
Detailed description
This is a risk reduction intervention for adults who are living with HIV, are experiencing trauma-related stress symptoms, and are at risk for HIV transmission. By first treating trauma symptoms, the effects of a skills-building HIV risk reduction intervention for adults experiencing trauma-related symptoms such as hyperarousal, dissociation, and avoidance will be enhanced. This is based on a model the proposes trauma-related symptoms have direct effects on HIV risk behavior. Therefore, the successful treatment of trauma-related symptoms will facilitate HIV risk behavior change.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care, Wait-List Control | Active comparator | Behavioral: HIV Skills-based PreventionParticipants received standard medical care, which in most clinics included informational brochures provided by physicians and clinic staff. Participants were given HIV prevention information and materials in English and Spanish and were provided referrals for services. Each individual completed assessments at immediate post intervention, 3-, 6-, and 12- months. At the end of the 12-month assessment, the wait-list control participants participated in the Trauma + HIV group arm. |
| HIV Prevention | Active comparator | Behavioral: HIV Skills-based PreventionEight, 90 minute group sessions. Three of the sessions focused on health education (e.g., medication adherence, nutrition, exercise) and five focused on HIV prevention skills (e.g., condom skills, communication, social support). Each individual completed assessments at immediate post intervention, 3-, 6-, and 12- months. At the end of the 12-month assessment, the participants in this arm were given the option to receive the 3 trauma-focused sessions from the Trauma + HIV group arm. |
| HIV Prevention plus Trauma | Active comparator | Behavioral: HIV Skills-based PreventionThe same format as the HIV Prevention arm with eight, 90 minute group sessions. The participants received the same five HIV prevention skills sessions along with three sessions that focused on reducing trauma-related stress (e.g., breathing training, relaxation exercises, grounding exercises, coping, trauma-related triggers). Each individual completed assessments at immediate post intervention, 3-, 6-, and 12- months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| HIV Skills-based Prevention | Behavioural | HIV Prevention, HIV Prevention plus Trauma, Standard of Care, Wait-List Control |
Primary outcome
To determine if decreasing trauma-related stress symptoms improves HIV risk reduction behavior above a standard HIV risk reduction intervention alone post -intervention 3, 6, and 12 months after the group intervention sessions.
Time frame: immediate post intervention, 3 months, 6 months, and 12 months
unprotected insertive and receptive sexual intercourse
To determine if decreasing trauma-related stress symptoms improves HIV risk reduction behavior above a standard HIV risk reduction intervention alone
Time frame: immediate post intervention, 3 months, 6 months, and 12 months
Mediation effect on trauma symptoms on HIV-related risk behavior
1 secondary outcome
To determine whether key variables moderate the intervention's effects.
Time frame: immediate post intervention, 3 months, 6 months and 12 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 18 Mar 2020.
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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.
Cheryl Gore-Felton Ph.D. principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV Skills-based Prevention in people with Stress Disorders, Post-Traumatic and HIV Infections, run by Stanford University 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?
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 18 Mar 2020. 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. 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?
To determine if decreasing trauma-related stress symptoms improves HIV risk reduction behavior above a standard HIV risk reduction intervention alone post -intervention 3, 6, and 12 months after the group intervention sessions. (time frame: immediate post intervention, 3 months, 6 months, and 12 months). The study lists 2 primary outcomes in all. 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 18 Mar 2020.