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OpenTrials
Completed

NCT Number: NCT01764698

Delivery of Anxiety Disorder Treatment in Addictions Centers

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Matrix Institute on Addictions, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CALM-SUD

Behavioral

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

Behavioral

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

  1. Brief Symptom Inventory

    Time frame: baseline, 6 weeks, 6 months

    Change over time is being assessed.

  2. Timeline Follow Back

    Time frame: baseline, 6 week, 6 month

    Change over time is being assessed

  3. Overall Anxiety Severity and Impairment Scale

    Time frame: baseline, 6 week, 6 month

    Change over time is being assessed.

Secondary outcomes

  1. urine toxicology screen

    Time frame: baseline, 6 week, 6 month

    Change over time is being assessed.

  2. Patient Health Questionnaire-8

    Time frame: baseline, 6 week, 6 month

    brief depression measure; Change over time is being assessed.

  3. Anxiety Sensitivity Index

    Time frame: baseline, 6 week, 6 month

    Change over time is being assessed.

  4. Panic Disorder Severity Scale

    Time frame: baseline, 6 week, 6 month

    Change over time is being assessed.

  5. Social Phobia Inventory

    Time frame: baseline, 6 week, 6 month

    Change over time is being assessed.

  6. Penn State Worry Questionnaire

    Time frame: baseline, 6 week, 6 month

    Change over time is being assessed.

  7. Posttraumatic Stress Disorder Checklist

    Time frame: baseline, 6 week, 6 month

    Change over time is being assessed.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

Adaptation of CALM for Comorbid Anxiety and Substance Use Disorders

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 9, 2013
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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