Study Targeting Affect Regulation

Phase 1

Completed

• Conditions: Substance Use Disorders; HIV; AIDS
• Interventions: Behavioral: Resilient Affective Processing Therapy (RAPT)

• Registration Number: NCT01237366
• Lead Sponsor: University of California, San Francisco

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 HIV/AIDS; 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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-11-01
• Study First Submitted QC: 2010-11-05
• Study First Posted: 2010-11-09
• Primary Completion: 2013-01
• Study Completion: 2014-05
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-23
• Last Update Posted: 2014-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 56

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

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Exclusion Criteria

• Do not have the capacity to provide informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reslient Affective Processing Therapy (RAPT)	Resilient Affective Processing Therapy (RAPT)	-

Primary Outcome Measures

Name	Time	Method
Traumatic stress symptom severity	3-month follow-up	Our team will use the Impact of Event Scale to measure the self-reported severity of traumatic stress symptoms related to HIV/AIDS.

Secondary Outcome Measures

Name	Time	Method
Psychological reactivity to expressive writing	1-month follow-up	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.

Trial Locations

Locations (1)

UCSF Center for AIDS Prevention Studies; 🇺🇸 San Francisco, California, United States