Anxiety Sensitivity Treatment for Heroin Users (ASTH-HR)
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anxiety sensitivity therapy
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring anxiety sensitivity, heroin
Eligibility Criteria
Inclusion Criteria:
- exhibit a score of 21 on a self-report measure of anxiety sensitivity
- be in 28 days of residential substance use treatment.
- meet criteria for current opioid dependence as determined by SCID interview administered at intake.
Exclusion Criteria:
- evidence of limited mental competency
- the inability to give informed, voluntary, written consent to participate
- current psychosis
- current bipolar disorder.
Sites / Locations
- Salvation Army Harbor Light Treatment Facilitiy
Outcomes
Primary Outcome Measures
Anxiety Sensitivity Index-3
Secondary Outcome Measures
Timeline Follow Back 90 days
Full Information
NCT ID
NCT01196312
First Posted
August 23, 2010
Last Updated
May 25, 2023
Sponsor
University of Maryland, College Park
1. Study Identification
Unique Protocol Identification Number
NCT01196312
Brief Title
Anxiety Sensitivity Treatment for Heroin Users
Acronym
ASTH-HR
Official Title
Novel Intervention for Drug Use and HIV Risk Among Anxiety Sensitive Heroin Users
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, College Park
4. Oversight
5. Study Description
Brief Summary
Anxiety Sensitivity Treatment for Heroin Users is a development project targeting mild and above levels of anxiety sensitivity that will involve the testing of a specialized protocol for improving treatment retention and outcomes for heroin dependent individuals in a residential substance use treatment. ASTH-HR will integrate established treatment modules such as Healthy Relationships, along with interoceptive exposure, affect management, and psycho-education exercises developed for anxiety prevention and treatment programs with standard substance use treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
anxiety sensitivity, heroin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Anxiety sensitivity therapy
Intervention Description
ASTH consists of 6 sessions of individual treatment, each lasting approximately 75 minutes over 3 weeks. In general, each session consists of the following components1) psychoeducation regarding the anxiety response, with a focus on increasing awareness of the ways in which the patient interprets or evaluates that response 2) assistance in developing healthy emotion regulation strategies that can be used to increase acceptance and tolerance of the anxiety response (including associated catastrophic thoughts), as well as understanding the consequences associated with avoidance or control of anxiety 3) a minimum of 3 interoceptive exercises tailored to activate feared anxiety-related sensations and 4) daily homework assignments (i.e., daily anxiety monitoring and interoceptive exercises).
Primary Outcome Measure Information:
Title
Anxiety Sensitivity Index-3
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Timeline Follow Back 90 days
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
exhibit a score of 21 on a self-report measure of anxiety sensitivity
be in 28 days of residential substance use treatment.
meet criteria for current opioid dependence as determined by SCID interview administered at intake.
Exclusion Criteria:
evidence of limited mental competency
the inability to give informed, voluntary, written consent to participate
current psychosis
current bipolar disorder.
Facility Information:
Facility Name
Salvation Army Harbor Light Treatment Facilitiy
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20002
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Anxiety Sensitivity Treatment for Heroin Users
We'll reach out to this number within 24 hrs