- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01237366
Study Targeting Affect Regulation (STAR)
October 23, 2014 updated by: University of California, San Francisco
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94105
- UCSF Center for AIDS Prevention Studies
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Reslient 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Adam Carrico, PhD, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
November 1, 2010
First Submitted That Met QC Criteria
November 5, 2010
First Posted (Estimate)
November 9, 2010
Study Record Updates
Last Update Posted (Estimate)
October 27, 2014
Last Update Submitted That Met QC Criteria
October 23, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R03DA029423 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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