Delivery of Anxiety Disorder Treatment in Addictions Centers

Study Overview
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Brief Summary
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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.

Official Title
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Adaptation of CALM for Comorbid Anxiety and Substance Use Disorders

Conditions
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Anxiety Disorders, Substance Use Disorders

Intervention / Treatment
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* Behavioral: CALM-SUD
* Behavioral: Treatment as usual


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CALM-SUD<br>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<br>* 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.<br>|
| Active Comparator: Treatment as usual<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Symptom Inventory | Change over time is being assessed. | baseline, 6 weeks, 6 months | 
| Timeline Follow Back | Change over time is being assessed | baseline, 6 week, 6 month | 
| Overall Anxiety Severity and Impairment Scale | Change over time is being assessed. | baseline, 6 week, 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urine toxicology screen | Change over time is being assessed. | baseline, 6 week, 6 month | 
| Patient Health Questionnaire-8 | brief depression measure; Change over time is being assessed. | baseline, 6 week, 6 month | 
| Anxiety Sensitivity Index | Change over time is being assessed. | baseline, 6 week, 6 month | 
| Panic Disorder Severity Scale | Change over time is being assessed. | baseline, 6 week, 6 month | 
| Social Phobia Inventory | Change over time is being assessed. | baseline, 6 week, 6 month | 
| Penn State Worry Questionnaire | Change over time is being assessed. | baseline, 6 week, 6 month | 
| Posttraumatic Stress Disorder Checklist | Change over time is being assessed. | baseline, 6 week, 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety disorders, substance use disorders, treatment effectiveness, cognitive behavioral therapy