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
  Purpose

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.


Condition Intervention Phase
HIV
AIDS
Substance Use Disorders
Behavioral: Resilient Affective Processing Therapy (RAPT)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Pilot RCT of Expressive Writing With HIV-Positive Methamphetamine Users

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 56
Study Start Date: September 2010
Estimated Study Completion Date: May 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reslient Affective Processing Therapy (RAPT) 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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01237366

Locations
United States, California
UCSF Center for AIDS Prevention Studies
San Francisco, California, United States, 94105
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Adam Carrico, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01237366     History of Changes
Other Study ID Numbers: R03-DA029423
Study First Received: November 1, 2010
Last Updated: August 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
HIV/AIDS
Methamphetamine
Trauma

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Substance-Related Disorders
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Chemically-Induced Disorders
Mental Disorders
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014