Study Targeting Affect Regulation - Full Text View

Purpose

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.

Condition	Intervention	Phase
HIV AIDS Substance Use Disorders	Behavioral: Resilient Affective Processing Therapy (RAPT)	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	A Pilot RCT of Expressive Writing With HIV-Positive Methamphetamine Users

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Methamphetamine

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Traumatic stress symptom severity [ Time Frame: 3-month follow-up ] [ Designated as safety issue: No ]
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 [ Time Frame: 1-month follow-up ] [ Designated as safety issue: No ]
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.


Enrollment:	56
Study Start Date:	September 2010
Study Completion Date:	May 2014
Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Reslient Affective Processing Therapy (RAPT)	Behavioral: Resilient 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.

Arms

Assigned Interventions

Experimental: Reslient Affective Processing Therapy (RAPT)

Behavioral: Resilient 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.

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01237366

Locations


United States, California
UCSF Center for AIDS Prevention Studies
San Francisco, California, United States, 94105

Sponsors and Collaborators

University of California, San Francisco

Investigators


Principal Investigator:	Adam Carrico, PhD	University of California, San Francisco

More Information


Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT01237366 History of Changes
Other Study ID Numbers:	R03DA029423
Study First Received:	November 1, 2010
Last Updated:	October 23, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:


HIV/AIDS Methamphetamine Trauma

Additional relevant MeSH terms:


Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Methamphetamine Central Nervous System Stimulants Physiological Effects of Drugs Sympathomimetics Autonomic Agents Peripheral Nervous System Agents	Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on September 27, 2016

Study Targeting Affect Regulation (STAR)