Ignite Creation Date:
2024-05-05 @ 11:02 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01237366
Status:
COMPLETED
Last Update Posted:
2014-10-27
First Post:
2010-11-01
Brief Title:
Study Targeting Affect Regulation
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Pilot RCT of Expressive Writing With HIV-Positive Methamphetamine Users
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR
Brief Summary:
This Phase Ib pilot RCT will examine the safety feasibility and acceptability of a multi-component intervention to address traumatic stress symptoms among HIV-positive methamphetamine-using men who have sex with men MSM Following a baseline assessment 56 participants will be randomized to receive either 1 a 7-session intervention to address traumatic stress related to living with HIVAIDS or 2 a 7-session attention-control condition Follow-up assessments will be administered at 1 and 3 months post-randomization
Detailed Description:
In the multi-component intervention protocol participants will complete expressive writing exercises where they will be asked to write about difficult life experiences Following expressive writing participants will receive stress management skills training to assist them with managing any acute increases in distress that arise from the writing experience Participants in the attention-control condition will write about neutral topics and complete psychological measures The overarching goals of this Phase Ib RCT will be to 1 examine the feasibility and acceptability of the intervention and attention-control and 2 determine whether intervention participants report reductions in traumatic stress symptoms over the 3 months following randomization Findings from this Phase Ib trial will inform our efforts to implement a more definitive RCT of this intervention with HIV-positive methamphetamine-using MSM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None