NCT01196312

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2010

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 8, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

1.4 years

First QC Date

August 23, 2010

Last Update Submit

May 25, 2023

Conditions

Keywords

anxiety sensitivityheroin

Outcome Measures

Primary Outcomes (1)

  • Anxiety Sensitivity Index-3

    24 weeks

Secondary Outcomes (1)

  • Timeline Follow Back 90 days

    24 weeks

Interventions

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 Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • evidence of limited mental competency
  • the inability to give informed, voluntary, written consent to participate
  • current psychosis
  • current bipolar disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salvation Army Harbor Light Treatment Facilitiy

Washington D.C., District of Columbia, 20002, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director - HRPP (C. Lejuez is no longer at UMD)

Study Record Dates

First Submitted

August 23, 2010

First Posted

September 8, 2010

Study Start

October 1, 2009

Primary Completion

March 1, 2011

Study Completion

September 1, 2011

Last Updated

May 30, 2023

Record last verified: 2023-05

Locations