Group Psychotherapy for People With HIV | NCT00186550

Studies
Group Psychotherapy for People With HIV

NCT00186550

Sponsor

Stanford University

Status

Completed

Last Update Posted

Dec 4, 2013Estimated

Enrollment

186Actual

Phase

Not Applicable

Conditions

HIV
Depression
Risk-taking
Pain

Interventions

Supportive Expressive Group Psychotherapy
Education

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01MH054930-04	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Nov 2000Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 16, 2005Estimated

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

Dec 3, 2013

Last Update Posted Date

Dec 4, 2013Estimated

Name	Class
National Institute of Mental Health (NIMH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study will examine the effectiveness of supportive-expressive group therapy plus education compared with an educational intervention in improving the quality of life and promoting health-enhancing behavior of men and women living with HIV or AIDS.

Detailed Description

The major goal of this project is to examine the effectiveness of supportive-expressive group therapy plus education in comparison to an educationally intervention in improving the quality of life and promoting health-enhancing behavior of men and women living with HIV/AIDS.

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

186Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1) a positive HIV diagnosis (either symptomatic or asymptomatic), 2) at least eighteen years of age, 3) English language skill (to complete questionnaires and participate, if assigned, to the group psychotherapy condition) and, 4) geographical proximity to groups in order to attend if assigned.

Exclusion Criteria:

1) severe psychiatric disorders (i.e. schizophrenia or other psychotic disorders)who would not be appropriate for participating in the group intervention, 2) active tuberculosis, 3) acute intoxication, 4) participation in an ongoing HIV/AIDS support group or 5) suicidal/homicidal ideation.

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
David Spiegel, M.D.	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University		Stanford	California	94305	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12391716	Background	Power R, Gore-Felton C, Vosvick M, Israelski DM, Spiegel D. HIV: effectiveness of complementary and alternative medicine. Prim Care. 2002 Jun;29(2):361-78. doi: 10.1016/s0095-4543(01)00013-6.
15581649	Result	Vosvick M, Gore-Felton C, Ashton E, Koopman C, Fluery T, Israelski D, Spiegel D. Sleep disturbances among HIV-positive adults: the role of pain, stress, and social support. J Psychosom Res. 2004 Nov;57(5):459-63. doi: 10.1016/j.jpsychores.2004.03.003.

ID	Term
D003863	Depression
D012309	Risk-Taking
D010146	Pain

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

ID	Term
D012959	Socioeconomic Factors
D011154	Population Characteristics

Name	Type	Description	Arm Group Labels	Other Names
Supportive Expressive Group Psychotherapy	Behavioral
Education	Behavioral