Study Targeting Affect Regulation (STAR)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01237366
First received: November 1, 2010
Last updated: August 19, 2013
Last verified: August 2013

November 1, 2010
August 19, 2013
September 2010
January 2013   (final data collection date for primary outcome measure)
Traumatic stress symptom severity [ Time Frame: 3-month follow-up ] [ Designated as safety issue: No ]
Our team will use the Impact of Event Scale to measure the self-reported severity of traumatic stress symptoms related to HIV/AIDS.
Traumatic stress symptom severity [ Time Frame: 1-month follow-up ] [ Designated as safety issue: No ]
Our team will use the Impact of Event Scale to measure the self-reported severity of traumatic stress symptoms related to HIV/AIDS.
Complete list of historical versions of study NCT01237366 on ClinicalTrials.gov Archive Site
Psychological reactivity to expressive writing [ Time Frame: 1-month follow-up ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Study Targeting Affect Regulation
A Pilot RCT of Expressive Writing With HIV-Positive Methamphetamine Users

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • HIV
  • AIDS
  • Substance Use Disorders
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.
  • Experimental: Reslient Affective Processing Therapy (RAPT)
    Intervention: Behavioral: Resilient Affective Processing Therapy (RAPT)
  • No Intervention: Attention-Control
    Participants will complete 7 sessions where they will be asked to write about neutral topics and complete psychological measures for the purposes of matching for attention and reimbursement.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
56
May 2014
January 2013   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01237366
R03-DA029423
Yes
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Adam Carrico, PhD University of California, San Francisco
University of California, San Francisco
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP