Delivery of Anxiety Disorder Treatment in Addictions Centers
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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 |
- 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.
- 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 |
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| 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 |
| 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. | |
| 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 |
ClinicalTrials.gov processed this record on June 17, 2013