Study Targeting Affect Regulation (STAR)
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ClinicalTrials.gov Identifier: NCT01237366 |
Recruitment Status
:
Completed
First Posted
: November 9, 2010
Last Update Posted
: October 27, 2014
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Condition or disease | Intervention/treatment | Phase |
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HIV AIDS Substance Use Disorders | Behavioral: Resilient Affective Processing Therapy (RAPT) | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 56 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | A Pilot RCT of Expressive Writing With HIV-Positive Methamphetamine Users |
Study Start Date : | September 2010 |
Actual Primary Completion Date : | January 2013 |
Actual Study Completion Date : | May 2014 |
Arm | Intervention/treatment |
---|---|
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.
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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.
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- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01237366
United States, California | |
UCSF Center for AIDS Prevention Studies | |
San Francisco, California, United States, 94105 |
Principal Investigator: | Adam Carrico, PhD | University of California, San Francisco |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT01237366 History of Changes |
Other Study ID Numbers: |
R03DA029423 ( U.S. NIH Grant/Contract ) |
First Posted: | November 9, 2010 Key Record Dates |
Last Update Posted: | October 27, 2014 |
Last Verified: | October 2014 |
Keywords provided by University of California, San Francisco:
HIV/AIDS Methamphetamine Trauma |
Additional relevant MeSH terms:
Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Methamphetamine Central Nervous System Stimulants Physiological Effects of Drugs Sympathomimetics Autonomic Agents Peripheral Nervous System Agents |
Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Dopamine Uptake Inhibitors |