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Delivery of Anxiety Disorder Treatment in Addictions Centers

Primary Purpose

Anxiety Disorders, Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CALM-SUD
Treatment as usual
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring anxiety disorders, substance use disorders, treatment effectiveness, cognitive behavioral therapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Matrix Institute on Addictions
  • University of California-Los Angeles, Department of Psychiatry and Biobehavioral Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CALM-SUD

Treatment as usual

Arm Description

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.

Participants in this arm receive the standard Intensive Outpatient treatment for their substance use disorder at a community addictions treatment facility.

Outcomes

Primary Outcome Measures

Brief Symptom Inventory
Change over time is being assessed.
Timeline Follow Back
Change over time is being assessed
Overall Anxiety Severity and Impairment Scale
Change over time is being assessed.

Secondary Outcome Measures

urine toxicology screen
Change over time is being assessed.
Patient Health Questionnaire-8
brief depression measure; Change over time is being assessed.
Anxiety Sensitivity Index
Change over time is being assessed.
Panic Disorder Severity Scale
Change over time is being assessed.
Social Phobia Inventory
Change over time is being assessed.
Penn State Worry Questionnaire
Change over time is being assessed.
Posttraumatic Stress Disorder Checklist
Change over time is being assessed.

Full Information

First Posted
December 17, 2012
Last Updated
October 24, 2017
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT01764698
Brief Title
Delivery of Anxiety Disorder Treatment in Addictions Centers
Official Title
Adaptation of CALM for Comorbid Anxiety and Substance Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 15, 2013 (Actual)
Primary Completion Date
November 15, 2016 (Actual)
Study Completion Date
November 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Substance Use Disorders
Keywords
anxiety disorders, substance use disorders, treatment effectiveness, cognitive behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CALM-SUD
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Participants in this arm receive the standard Intensive Outpatient treatment for their substance use disorder at a community addictions treatment facility.
Intervention Type
Behavioral
Intervention Name(s)
CALM-SUD
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
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 Outcome Measure Information:
Title
Brief Symptom Inventory
Description
Change over time is being assessed.
Time Frame
baseline, 6 weeks, 6 months
Title
Timeline Follow Back
Description
Change over time is being assessed
Time Frame
baseline, 6 week, 6 month
Title
Overall Anxiety Severity and Impairment Scale
Description
Change over time is being assessed.
Time Frame
baseline, 6 week, 6 month
Secondary Outcome Measure Information:
Title
urine toxicology screen
Description
Change over time is being assessed.
Time Frame
baseline, 6 week, 6 month
Title
Patient Health Questionnaire-8
Description
brief depression measure; Change over time is being assessed.
Time Frame
baseline, 6 week, 6 month
Title
Anxiety Sensitivity Index
Description
Change over time is being assessed.
Time Frame
baseline, 6 week, 6 month
Title
Panic Disorder Severity Scale
Description
Change over time is being assessed.
Time Frame
baseline, 6 week, 6 month
Title
Social Phobia Inventory
Description
Change over time is being assessed.
Time Frame
baseline, 6 week, 6 month
Title
Penn State Worry Questionnaire
Description
Change over time is being assessed.
Time Frame
baseline, 6 week, 6 month
Title
Posttraumatic Stress Disorder Checklist
Description
Change over time is being assessed.
Time Frame
baseline, 6 week, 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate B Taylor, Ph.D.
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Matrix Institute on Addictions
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
University of California-Los Angeles, Department of Psychiatry and Biobehavioral Sciences
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29852309
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.
Results Reference
derived
PubMed Identifier
29300100
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.
Results Reference
derived

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Delivery of Anxiety Disorder Treatment in Addictions Centers

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