Stress Disorders, Post-TraumaticPEACHNCT00599599
Stress-Reducing Interventions in HIV+ Patients: Pilot
A study testing Prolonged Exposure Therapy in people with Stress Disorders, Post-Traumatic and HIV Infections, run by Kent State University at 2 sites in United States.
Trial summary
The primary aim of this project is to examine the efficacy of prolonged exposure (PE) therapy at reducing HIV-related PTSD symptoms, increasing adherence to antiretroviral medication regimens, and increasing health-related quality of life (QOL) in HIV+ patients. 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?
- Prolonged Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2005to Feb 2010
- 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
Who may be able to join
- Must be HIV+
- Must meet PTSD diagnostic criteria
- Must be taking HIV medications
- Must be able to read and write in English
Who cannot join
- Current or previous diagnosis of schizophrenia, any current diagnosis with psychotic features, or current suicidal ideation
- Being in a current abusive relationship or ongoing intimate relationship with one's assailant
- Mental retardation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Violet's Cupboard
Akron, Ohio, 44310
AIDS Taskforce of Greater Cleveland
Cleveland, Ohio, 44115
About this study
Official title: Pilot Intervention for PTSD, Nonadherence, and HIV Risk
The primary aim of this project is to examine the efficacy of prolonged exposure (PE) therapy at reducing HIV-related PTSD symptoms, increasing adherence to antiretroviral medication regimens, and increasing health-related quality of life (QOL) in HIV+ patients.
Read the detailed description
HIV+ patients will be randomized to receive either PE therapy (up to 18 possible sessions) or weekly symptom monitoring (described below) and will complete measures of PTSD, adherence, and QOL pre- and post-intervention and at 3- and 6-month follow-up assessments. Secondary analyses will examine the impact of the intervention on disorders commonly comorbid with PTSD (i.e., anxiety, mood, and substance abuse/dependence disorders).
- Conditions
- Stress Disorders, Post-Traumatic, HIV Infections
- Being tested
- Prolonged Exposure Therapy
- Keywords
- Prolonged Exposure Therapy, Adherence to HIV Medications, 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.
Prolonged Exposure TherapyBehavioural
Participants will meet with a therapist twice a week for 5 weeks to complete the therapy. If the therapist and participant feel more sessions are needed, an additional 8 sessions will be provided.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Prolonged Exposure Therapy. Receives: Behavioral: Prolonged Exposure Therapy |
| 2 | No intervention | Weekly monitoring/Waitlist Control Group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD symptoms
Measured: pre- & post-intervention, 3-month post, & 6-month post
Secondary outcomes (2)
Adherence to HIV medications
Measured: pre- & post-intervention, 3-month post, & 6-month post
Health-related Quality of Life
Measured: pre- & post-intervention, 3-month post, & 6-month post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startApr 2005
- Primary completionFeb 2009 (estimated)
- Study completionFeb 2010 (estimated)
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.
- 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
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kent State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Summa Health System
- Investigators
- Douglas L Delahanty, PhD, Principal investigator, Kent State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599599
- Sponsor's protocol ID
- R34MH071201-01A1
- Other IDs
- NIMH, 1 R34 MH071201-01A1
- Acronym
- PEACH
- Status last verified
- Mar 2009
- First submitted
- 11 Jan 2008
- Last updated
- 5 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Intervention for PTSD, Nonadherence, and HIV Risk
- ClinicalTrials.gov ID
- NCT00599599
- Acronym / sponsor ID
- PEACH / R34MH071201-01A1
- Conditions
- Stress Disorders, Post-Traumatic, HIV Infections
- Keywords
- Prolonged Exposure Therapy, Adherence to HIV Medications, Complementary Therapies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Kent State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Summa Health System
- Study start
- Apr 2005
- Primary completion
- Feb 2009 (estimated)
- Study completion
- Feb 2010 (estimated)
- First posted
- 24 Jan 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.
The primary aim of this project is to examine the efficacy of prolonged exposure (PE) therapy at reducing HIV-related PTSD symptoms, increasing adherence to antiretroviral medication regimens, and increasing health-related quality of life (QOL) in HIV+ patients.
Detailed description
HIV+ patients will be randomized to receive either PE therapy (up to 18 possible sessions) or weekly symptom monitoring (described below) and will complete measures of PTSD, adherence, and QOL pre- and post-intervention and at 3- and 6-month follow-up assessments. Secondary analyses will examine the impact of the intervention on disorders commonly comorbid with PTSD (i.e., anxiety, mood, and substance abuse/dependence disorders).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Prolonged Exposure TherapyProlonged Exposure Therapy. |
| 2 | No intervention | –Weekly monitoring/Waitlist Control Group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be HIV+
- Must meet PTSD diagnostic criteria
- Must be taking HIV medications
- Must be able to read and write in English
Key exclusion criteria (3 listed)
- Current or previous diagnosis of schizophrenia, any current diagnosis with psychotic features, or current suicidal ideation
- Being in a current abusive relationship or ongoing intimate relationship with one's assailant
- Mental retardation
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 |
|---|---|---|
| Prolonged Exposure TherapyParticipants will meet with a therapist twice a week for 5 weeks to complete the therapy. If the therapist and participant feel more sessions are needed, an additional 8 sessions will be provided. | Behavioural | 1 |
Primary outcome
PTSD symptoms
Time frame: pre- & post-intervention, 3-month post, & 6-month post
2 secondary outcomes
Adherence to HIV medications
Time frame: pre- & post-intervention, 3-month post, & 6-month post
Health-related Quality of Life
Time frame: pre- & post-intervention, 3-month post, & 6-month post
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 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.
Douglas L Delahanty, PhD principal investigator
Kent State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Exposure Therapy in people with Stress Disorders, Post-Traumatic and HIV Infections, run by Kent State University at 2 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
Results are not available in the source record.
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?
PTSD symptoms (time frame: pre- & post-intervention, 3-month post, & 6-month post). 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 5 Mar 2009.