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Study Targeting Affect Regulation (STAR)

Primary Purpose

HIV, AIDS, Substance Use Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Resilient Affective Processing Therapy (RAPT)
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV focused on measuring HIV/AIDS, Methamphetamine, Trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • UCSF Center for AIDS Prevention Studies

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Reslient Affective Processing Therapy (RAPT)

Attention-Control

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Psychological reactivity to expressive writing
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.

Full Information

First Posted
November 1, 2010
Last Updated
October 23, 2014
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01237366
Brief Title
Study Targeting Affect Regulation
Acronym
STAR
Official Title
A Pilot RCT of Expressive Writing With HIV-Positive Methamphetamine Users
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, AIDS, Substance Use Disorders
Keywords
HIV/AIDS, Methamphetamine, Trauma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reslient Affective Processing Therapy (RAPT)
Arm Type
Experimental
Arm Title
Attention-Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Resilient Affective Processing Therapy (RAPT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Traumatic stress symptom severity
Description
Our team will use the Impact of Event Scale to measure the self-reported severity of traumatic stress symptoms related to HIV/AIDS.
Time Frame
3-month follow-up
Secondary Outcome Measure Information:
Title
Psychological reactivity to expressive writing
Description
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.
Time Frame
1-month follow-up

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Carrico, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Center for AIDS Prevention Studies
City
San Francisco
State/Province
California
ZIP/Postal Code
94105
Country
United States

12. IPD Sharing Statement

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Study Targeting Affect Regulation

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