Delivery of Anxiety Disorder Treatment in Addictions Centers

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by University of Southern California
Sponsor:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT01764698
First received: December 17, 2012
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

Anxiety disorders are highly prevalent among those with substance use disorders, but the majority of addictions treatment centers provide little to no evidence-based treatment for anxiety disorders. Furthermore, tension reduction models suggest that treating anxiety should also improve substance use outcomes. This study is aimed at improving symptoms for people who have substance use and anxiety problems. The study is comparing regular Intensive Outpatient treatment for addiction to Intensive Outpatient treatment for addiction plus treatment for anxiety disorders. Clinicians at a community addictions clinic will participate by receiving training in delivering cognitive behavioral therapy for anxiety disorders and will deliver the treatment to the patient participants. They will also complete some questionnaires. Patient participants will be asked to complete a baseline assessment. Those who are eligible will be randomly assigned to one of the two treatment groups. Those who are assigned to addiction treatment as usual will continue their regular care at the Matrix Institute. Participants who are assigned to also receive the anxiety treatment will be asked to participate in 6, 90-min treatment sessions and an orientation session. All participants will be asked to complete post-treatment and follow-up assessments. The assessments should take approximately 1 hour, and the follow-up assessment will be completed 6 months after treatment is over. It is hypothesized that those who get the additional anxiety disorder treatment will show greater improvement in anxiety and substance use outcomes than those who get Intensive Outpatient Program without the anxiety disorder treatment.


Condition Intervention
Anxiety Disorders
Substance Use Disorders
Behavioral: CALM-SUD
Behavioral: Treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adaptation of CALM for Comorbid Anxiety and Substance Use Disorders

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Brief Symptom Inventory [ Time Frame: baseline, 6 weeks, 6 months ] [ Designated as safety issue: No ]
    Change over time is being assessed.

  • Timeline Follow Back [ Time Frame: baseline, 6 week, 6 month ] [ Designated as safety issue: No ]
    Change over time is being assessed

  • Overall Anxiety Severity and Impairment Scale [ Time Frame: baseline, 6 week, 6 month ] [ Designated as safety issue: No ]
    Change over time is being assessed.


Secondary Outcome Measures:
  • urine toxicology screen [ Time Frame: baseline, 6 week, 6 month ] [ Designated as safety issue: No ]
    Change over time is being assessed.

  • Patient Health Questionnaire-8 [ Time Frame: baseline, 6 week, 6 month ] [ Designated as safety issue: No ]
    brief depression measure; Change over time is being assessed.

  • Anxiety Sensitivity Index [ Time Frame: baseline, 6 week, 6 month ] [ Designated as safety issue: No ]
    Change over time is being assessed.

  • Panic Disorder Severity Scale [ Time Frame: baseline, 6 week, 6 month ] [ Designated as safety issue: No ]
    Change over time is being assessed.

  • Social Phobia Inventory [ Time Frame: baseline, 6 week, 6 month ] [ Designated as safety issue: No ]
    Change over time is being assessed.

  • Penn State Worry Questionnaire [ Time Frame: baseline, 6 week, 6 month ] [ Designated as safety issue: No ]
    Change over time is being assessed.

  • Posttraumatic Stress Disorder Checklist [ Time Frame: baseline, 6 week, 6 month ] [ Designated as safety issue: No ]
    Change over time is being assessed.


Estimated Enrollment: 80
Study Start Date: November 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CALM-SUD
Participants receive the adaptation of the Coordinated Anxiety Learning and Management (CALM) protocol that demonstrated effectiveness in a large primary care sample. CALM will be adapted for those with anxiety and substance use disorder comorbidity, and will consist of an orientation session and 6 group treatment sessions. These participants will also receive substance abuse treatment as usual at a community Intensive Outpatient Program.
Behavioral: CALM-SUD
6-session group for anxiety disorders. Cognitive behavioral therapy including self-monitoring, relaxation, cognitive restructuring, exposure therapy, and relapse prevention. In addition, participants in this arm are also enrolled in an Intensive Outpatient Program for their substance use disorder. The program is run by an outpatient addictions facility and includes up to 16 weeks of groups that meet 3 to 4 times per week in addition to up to 10 individual sessions of therapy. The group model includes motivational interviewing, cognitive behavioral therapy, contingency management, and relapse prevention skills.
Active Comparator: Treatment as usual
Participants in this arm receive the standard Intensive Outpatient treatment for their substance use disorder at a community addictions treatment facility.
Behavioral: Treatment as usual
The program is run by an outpatient addictions facility and includes up to 16 weeks of groups that meet 3 to 4 times per week in addition to up to 10 individual sessions of therapy. The group model includes motivational interviewing, cognitive behavioral therapy, contingency management, and relapse prevention skills.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-55 years old
  • speak English
  • meet diagnostic criteria for at least one anxiety disorder
  • score at least an 8 on the OASIS (see Assessments), indicating at least moderate but clinically significant anxiety symptoms
  • be enrolled in the Intensive Outpatient Program (IOP) at the Matrix Institute (community partner)
  • meet diagnostic criteria for substance abuse or dependence

Exclusion Criteria:

  • have unstable medical conditions
  • marked cognitive impairment
  • active suicidal intent or plan
  • active psychosis
  • unstable Bipolar I 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: NCT01764698

Contacts
Contact: Kate B Taylor, Ph.D. 323-442-4024 kbtaylor@usc.edu
Contact: Michelle G Craske, Ph.D. 310-825-8403 craske@psych.ucla.edu

Locations
United States, California
University of Southern California, Department of Psychiatry and Behavioral Sciences Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Kate B Taylor, Ph.D.    323-442-4024    kbtaylor@usc.edu   
Principal Investigator: Kate B Taylor, Ph.D.         
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Kate B Taylor, Ph.D. University of Southern California
  More Information

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT01764698     History of Changes
Other Study ID Numbers: 7K23DA031677
Study First Received: December 17, 2012
Last Updated: January 7, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Southern California:
anxiety disorders
substance use disorders
treatment effectiveness
cognitive behavioral therapy

Additional relevant MeSH terms:
Anxiety Disorders
Substance-Related Disorders
Mental Disorders
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on August 21, 2014