Clinical trial NCT01764698: Delivery of Anxiety Disorder Treatment in Addictions Centers
Official title: Adaptation of CALM for Comorbid Anxiety and Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Substance Use Disorders
Keywords: anxiety disorders
substance use disorders
treatment effectiveness
cognitive behavioral therapy
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2013-01-09
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Brief Symptom Inventory
timeFrame: baseline, 6 weeks, 6 months
measure: Timeline Follow Back
timeFrame: baseline, 6 week, 6 month
measure: Overall Anxiety Severity and Impairment Scale
timeFrame: baseline, 6 week, 6 month
Secondary outcomes:
measure: urine toxicology screen
timeFrame: baseline, 6 week, 6 month
measure: Patient Health Questionnaire-8
timeFrame: baseline, 6 week, 6 month
measure: Anxiety Sensitivity Index
timeFrame: baseline, 6 week, 6 month
measure: Panic Disorder Severity Scale
timeFrame: baseline, 6 week, 6 month
measure: Social Phobia Inventory
timeFrame: baseline, 6 week, 6 month
measure: Penn State Worry Questionnaire
timeFrame: baseline, 6 week, 6 month
measure: Posttraumatic Stress Disorder Checklist
timeFrame: baseline, 6 week, 6 month
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Matrix Institute on Addictions
state: California
city: Los Angeles
country: United States
facility: University of California-Los Angeles, Department of Psychiatry and Biobehavioral Sciences
state: California
Study officials:
affiliation: University of Southern California
name: Kate B Taylor, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wolitzky-Taylor K, Drazdowski TK, Niles A, Roy-Byrne P, Ries R, Rawson R, Craske MG. Change in anxiety sensitivity and substance use coping motives as putative mediators of treatment efficacy among substance users. Behav Res Ther. 2018 Aug;107:34-41. doi: 10.1016/j.brat.2018.05.010. Epub 2018 May 24.
citation: Wolitzky-Taylor K, Krull J, Rawson R, Roy-Byrne P, Ries R, Craske MG. Randomized clinical trial evaluating the preliminary effectiveness of an integrated anxiety disorder treatment in substance use disorder specialty clinics. J Consult Clin Psychol. 2018 Jan;86(1):81-88. doi: 10.1037/ccp0000276.