Study Targeting Affect Regulation

NCT01237366 | Completed Phase 1 DMC

• 1 other identifier: R03DA029423
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV; AIDS; Substance Use Disorders

Keywords

HIV/AIDS; Methamphetamine; Trauma

Outcome Measures

Primary Outcomes (1)

• Traumatic stress symptom severity

  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 Outcomes (1)

• Psychological reactivity to expressive writing

  1-month follow-up

Study Arms (2)

Reslient Affective Processing Therapy (RAPT)

EXPERIMENTAL

Behavioral: Resilient Affective Processing Therapy (RAPT)

Attention-Control

NO INTERVENTION

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.

Interventions

Resilient Affective Processing Therapy (RAPT) BEHAVIORAL

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.

Reslient Affective Processing Therapy (RAPT)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Do not have the capacity to provide informed consent

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Center for AIDS Prevention Studies

San Francisco, California, 94105, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Substance-Related Disorders; Wounds and Injuries

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Adam Carrico, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2010
• First Posted: November 9, 2010
• Study Start: September 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: May 1, 2014
• Last Updated: October 27, 2014

Record last verified: 2014-10

Locations

US (1)