NCT01764698

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2012

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
10 months until next milestone

Study Start

First participant enrolled

November 15, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2016

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

3 years

First QC Date

December 17, 2012

Last Update Submit

October 24, 2017

Conditions

Anxiety DisordersSubstance Use Disorders

Keywords

anxiety disorderssubstance use disorderstreatment effectivenesscognitive behavioral therapy

Outcome Measures

Primary Outcomes (3)

  • Brief Symptom Inventory

    Change over time is being assessed.

    baseline, 6 weeks, 6 months

  • Timeline Follow Back

    Change over time is being assessed

    baseline, 6 week, 6 month

  • Overall Anxiety Severity and Impairment Scale

    Change over time is being assessed.

    baseline, 6 week, 6 month

Secondary Outcomes (7)

  • urine toxicology screen

    baseline, 6 week, 6 month

  • Patient Health Questionnaire-8

    baseline, 6 week, 6 month

  • Anxiety Sensitivity Index

    baseline, 6 week, 6 month

  • Panic Disorder Severity Scale

    baseline, 6 week, 6 month

  • Social Phobia Inventory

    baseline, 6 week, 6 month

  • +2 more secondary outcomes

Study Arms (2)

CALM-SUD

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.

Behavioral: CALM-SUD

Treatment as usual

ACTIVE COMPARATOR

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

Interventions

CALM-SUDBEHAVIORAL

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.

CALM-SUD
Treatment as usualBEHAVIORAL

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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • have unstable medical conditions
  • marked cognitive impairment
  • active suicidal intent or plan
  • active psychosis
  • unstable Bipolar I disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Matrix Institute on Addictions

Los Angeles, California, 90025, United States

Location

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

Los Angeles, California, 90025, United States

Location

Related Publications (2)

  • 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.

    PMID: 29852309DERIVED

  • 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.

    PMID: 29300100DERIVED

MeSH Terms

Conditions

Anxiety DisordersSubstance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental DisordersChemically-Induced Disorders

Study Officials

  • Kate B Taylor, Ph.D.

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 17, 2012

First Posted

January 9, 2013

Study Start

November 15, 2013

Primary Completion

November 15, 2016

Study Completion

November 15, 2016

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations

US(2)