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OpenTrials
Completed

NCT Number: NCT01237366

Study Targeting Affect Regulation

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resilient Affective Processing Therapy (RAPT)

Behavioral

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.

Primary outcomes

  1. Traumatic stress symptom severity

    Time frame: 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 outcomes

  1. Psychological reactivity to expressive writing

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Acronym: STAR

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Nov 9, 2010
Registry last updated
Oct 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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