Overview

This trial is active, not recruiting.

Conditions anxiety disorders, substance use disorders
Treatments calm-sud, treatment as usual
Sponsor University of California, Los Angeles
Start date November 2013
End date October 2017
Trial size 98 participants
Trial identifier NCT01764698, 7K23DA031677

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
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)
Participants in this arm receive the standard Intensive Outpatient treatment for their substance use disorder at a community addictions treatment facility.
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.

Primary Outcomes

Measure
Brief Symptom Inventory
time frame: baseline, 6 weeks, 6 months
Timeline Follow Back
time frame: baseline, 6 week, 6 month
Overall Anxiety Severity and Impairment Scale
time frame: baseline, 6 week, 6 month

Secondary Outcomes

Measure
urine toxicology screen
time frame: baseline, 6 week, 6 month
Patient Health Questionnaire-8
time frame: baseline, 6 week, 6 month
Anxiety Sensitivity Index
time frame: baseline, 6 week, 6 month
Panic Disorder Severity Scale
time frame: baseline, 6 week, 6 month
Social Phobia Inventory
time frame: baseline, 6 week, 6 month
Penn State Worry Questionnaire
time frame: baseline, 6 week, 6 month
Posttraumatic Stress Disorder Checklist
time frame: baseline, 6 week, 6 month

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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.

Additional Information

Official title Adaptation of CALM for Comorbid Anxiety and Substance Use Disorders
Principal investigator Kate B Taylor, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of California, Los Angeles.