Stress-Reducing Interventions in HIV+ Patients: Pilot | NCT00599599

Studies
Stress-Reducing Interventions in HIV+ Patients: Pilot

NCT00599599

Sponsor

Kent State University

Status

Unknown status

Last Update Posted

Mar 5, 2009Estimated

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Stress Disorders, Post-Traumatic
HIV Infections

Interventions

Prolonged Exposure Therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NIMH, 1 R34 MH071201-01A1

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2005

Primary Completion Date

Feb 2009Estimated

Completion Date

Feb 2010Estimated

First Submitted Date

Jan 11, 2008

First Submission Date that Met QC Criteria

Jan 23, 2008

First Posted Date

Jan 24, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2009

Last Update Posted Date

Mar 5, 2009Estimated

Name	Class
National Institute of Mental Health (NIMH)	NIH
Summa Health System	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Prolonged Exposure Therapy.	Behavioral: Prolonged Exposure Therapy
2	No Intervention	Weekly monitoring/Waitlist Control Group.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prolonged Exposure Therapy	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PTSD symptoms		pre- & post-intervention, 3-month post, & 6-month post

Secondary Outcomes

Measure	Description	Time Frame
Adherence to HIV medications		pre- & post-intervention, 3-month post, & 6-month post
Health-related Quality of Life		pre- & post-intervention, 3-month post, & 6-month post

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be HIV+
Must meet PTSD diagnostic criteria
Must be taking HIV medications
Must be able to read and write in English

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Douglas L Delahanty, PhD	Kent State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Violet's Cupboard		Akron	Ohio	44310	United States
AIDS Taskforce of Greater Cleveland

Type	Date	Date Unknown
Release	Apr 9, 2014
Reset	May 8, 2014

Submission Tracking

Estimated Results First Submitted Date

Apr 9, 2014

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 9, 2014			May 8, 2014

Condition Browse Module

MeSH Terms

ID	Term
D013313	Stress Disorders, Post-Traumatic
D015658	HIV Infections

Ancestor Terms

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders
D000086982	Blood-Borne Infections

Browse Leaves

Not provided

Browse Branches

Not provided