Stress-Reducing Interventions in HIV+ Patients: Pilot

NCT00599599 | Unknown DMC

• 2 other identifiers: R34MH071201-01A1NIMH, 1 R34 MH071201-01A1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Stress Disorders, Post-Traumatic; HIV Infections

Keywords

Prolonged Exposure Therapy; Adherence to HIV Medications; Complementary Therapies

Outcome Measures

Primary Outcomes (1)

• PTSD symptoms

  pre- & post-intervention, 3-month post, & 6-month post

Secondary Outcomes (2)

• 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

Study Arms (2)

1

EXPERIMENTAL

Prolonged Exposure Therapy.

Behavioral: Prolonged Exposure Therapy

2

NO INTERVENTION

Weekly monitoring/Waitlist Control Group.

Interventions

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kent State University: lead
• National Institute of Mental Health (NIMH): collaborator
• Summa Health System: collaborator

Study Sites (2)

Violet's Cupboard

Akron, Ohio, 44310, United States

Location

AIDS Taskforce of Greater Cleveland

Cleveland, Ohio, 44115, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; HIV Infections

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Douglas L Delahanty, PhD

  Kent State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: January 24, 2008
• Study Start: April 1, 2005
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2010
• Last Updated: March 5, 2009

Record last verified: 2009-03

Locations

US (2)