Study Targeting Affect Regulation
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS, Psychiatric |
| Therapuetic Areas: | Immunology / Infectious Diseases, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/30/-0001 |
| Start Date: | September 2010 |
| End Date: | December 2013 |
| Contact: | Walter Gomez, M.A. |
| Email: | walter.gomez@ucsf.edu |
| Phone: | 415-597-9388 |
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.
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
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