Delivery of Anxiety Disorder Treatment in Addictions Centers

Anxiety Disorders Clinical Trial

Official title:

Adaptation of CALM for Comorbid Anxiety and Substance Use Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764698
• Other study ID #: 7K23DA031677
• Status: Completed
• Phase: N/A
• First received: December 17, 2012
• Last updated: October 24, 2017
• Start date: November 15, 2013
• Est. completion date: November 15, 2016

Study information

• Verified date: October 2017
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: November 15, 2016
• Est. primary completion date: November 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 18-60 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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Matrix Institute on Addictions	Los Angeles	California
United States	University of California-Los Angeles, Department of Psychiatry and Biobehavioral Sciences	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Symptom Inventory	Change over time is being assessed.	baseline, 6 weeks, 6 months
Primary	Timeline Follow Back	Change over time is being assessed	baseline, 6 week, 6 month
Primary	Overall Anxiety Severity and Impairment Scale	Change over time is being assessed.	baseline, 6 week, 6 month
Secondary	urine toxicology screen	Change over time is being assessed.	baseline, 6 week, 6 month
Secondary	Patient Health Questionnaire-8	brief depression measure; Change over time is being assessed.	baseline, 6 week, 6 month
Secondary	Anxiety Sensitivity Index	Change over time is being assessed.	baseline, 6 week, 6 month
Secondary	Panic Disorder Severity Scale	Change over time is being assessed.	baseline, 6 week, 6 month
Secondary	Social Phobia Inventory	Change over time is being assessed.	baseline, 6 week, 6 month
Secondary	Penn State Worry Questionnaire	Change over time is being assessed.	baseline, 6 week, 6 month
Secondary	Posttraumatic Stress Disorder Checklist	Change over time is being assessed.	baseline, 6 week, 6 month