Delivery of Anxiety Disorder Treatment in Addictions Centers

NCT ID: NCT01764698

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-15

Study Completion Date

2016-11-15

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.

Detailed Description

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Conditions

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Anxiety Disorders Substance Use Disorders

Keywords

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anxiety disorders substance use disorders treatment effectiveness cognitive behavioral therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

CALM-SUD

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Kate Taylor

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kate B Taylor, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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Matrix Institute on Addictions

Los Angeles, California, United States

Site Status

University of California-Los Angeles, Department of Psychiatry and Biobehavioral Sciences

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29852309 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29300100 (View on PubMed)

Other Identifiers

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7K23DA031677

Identifier Type: NIH

Identifier Source: org_study_id

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