Anxiety Sensitivity Treatment for Heroin Users (ASTH-HR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Maryland.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT01196312
First received: August 23, 2010
Last updated: September 3, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Anxiety
Behavioral: Anxiety sensitivity therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Novel Intervention for Drug Use and HIV Risk Among Anxiety Sensitive Heroin Users

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Anxiety Sensitivity Index-3 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Timeline Follow Back 90 days [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Anxiety sensitivity therapy
    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).
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT01196312

Contacts
Contact: Carl W Lejuez, PhD (301)405-5932 clejuez@psyc.umd.edu

Locations
United States, District of Columbia
Salvation Army Harbor Light Treatment Facilitiy Recruiting
Washington, District of Columbia, United States, 20002
Contact    202-269-6333      
Principal Investigator: Carl Lejuez, PhD         
Sponsors and Collaborators
University of Maryland
  More Information

No publications provided

Responsible Party: Dr. Carl W. Lejuez, Department of Psychology University Of Maryland, College Park
ClinicalTrials.gov Identifier: NCT01196312     History of Changes
Other Study ID Numbers: DA023384
Study First Received: August 23, 2010
Last Updated: September 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
anxiety sensitivity
heroin

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Heroin
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on July 26, 2014