Study Targeting Affect Regulation (STAR)

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 2; Phase 1

Conditions: AIDS; HIV; Substance Use Disorders

Treatments: Behavioral: Resilient Affective Processing Therapy (RAPT)

Study type: Interventional

Funder types: Other

Identifiers

NCT01237366

R03DA029423

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Reslient Affective Processing Therapy (RAPT)

Experimental group

Treatment:

Behavioral: Resilient Affective Processing Therapy (RAPT)

Attention-Control

No Intervention group

Description:

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.