Study Targeting Affect Regulation (STAR)
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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 |
- 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.
- 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: | December 2013 |
| Estimated Primary Completion Date: | May 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 |
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| Contact: Walter Gomez, M.A. | 415-597-9388 | walter.gomez@ucsf.edu |
| United States, California | |
| UCSF Center for AIDS Prevention Studies | Recruiting |
| San Francisco, California, United States, 94105 | |
| Principal Investigator: | Adam Carrico, PhD | University of California, San Francisco |
More Information
Additional 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: | October 8, 2012 |
| 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 Mental Disorders Methamphetamine Amphetamine |
Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013