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
Recruitment status was Recruiting
Sponsor:
University of Maryland
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT01196312
First received: August 23, 2010
Last updated: September 3, 2010
Last verified: September 2010
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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
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 May 16, 2013