Study Targeting Affect Regulation

HIV Clinical Trial

— STAR  

Official title:

A Pilot RCT of Expressive Writing With HIV-Positive Methamphetamine Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01237366
• Other study ID #: R03DA029423
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 1, 2010
• Last updated: October 23, 2014
• Start date: September 2010
• Est. completion date: May 2014

Study information

• Verified date: October 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 HIV/AIDS; or 2) a 7-session, attention-control condition. Follow-up assessments will be administered at 1 and 3 months post-randomization.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Speak English

• Self-identify as a man who has sex with men

• Have been diagnosed with HIV for at least 3 months

• Provide evidence of HIV-positive serostatus

• Report using methamphetamine during the past 30 days

Exclusion Criteria:

• Do not have the capacity to provide informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• AIDS
• HIV
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Resilient Affective Processing Therapy (RAPT)
Participants will be asked to complete 7 intervention sessions which include: 1) expressive writing exercises that focus on exploring thoughts and feelings surrounding a difficult life experience; and 2) stress management skills training to assist participants with managing any acute increases in distress that arise following the writing experience.

Locations

Country	Name	City	State
United States	UCSF Center for AIDS Prevention Studies	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Traumatic stress symptom severity	Our team will use the Impact of Event Scale to measure the self-reported severity of traumatic stress symptoms related to HIV/AIDS.	3-month follow-up	No
Secondary	Psychological reactivity to expressive writing	Participants will complete measures of subjective distress and craving of stimulants (i.e., methamphetamine, cocaine, and crack) before and after each expressive writing exercise to provide an index of habituation. Habituation is defined as a 50% reduction in the psychological reactivity to the expressive writing experience using these self-report measures.	1-month follow-up	No