Anxiety DisordersNCT01764698
Delivery of Anxiety Disorder Treatment in Addictions Centers
A study testing CALM-SUD and Treatment as usual in people with Anxiety Disorders and Substance Use Disorders, run by University of California, Los Angeles at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anxiety Disorders, Substance Use Disorders
- What is being tested?
- CALM-SUD and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Nov 2013to 15 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- have unstable medical conditions
- marked cognitive impairment
- active suicidal intent or plan
- active psychosis
- unstable Bipolar I disorder.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Matrix Institute on Addictions
Los Angeles, California, 90025
University of California-Los Angeles, Department of Psychiatry and Biobehavioral Sciences
Los Angeles, California, 90025
About this study
Official title: Adaptation of CALM for Comorbid Anxiety and Substance Use Disorders
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.
- Conditions
- Anxiety Disorders, Substance Use Disorders
- Being tested
- CALM-SUD, Treatment as usual
- Keywords
- anxiety disorders, substance use disorders, treatment effectiveness, cognitive behavioral therapy
- Medical subject headings
- Anxiety Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CALM-SUDBehavioural
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 usualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Symptom Inventory
Change over time is being assessed.
Measured: baseline, 6 weeks, 6 months
Timeline Follow Back
Change over time is being assessed
Measured: baseline, 6 week, 6 month
Overall Anxiety Severity and Impairment Scale
Change over time is being assessed.
Measured: baseline, 6 week, 6 month
Secondary outcomes (7)
urine toxicology screen
Change over time is being assessed.
Measured: baseline, 6 week, 6 month
Patient Health Questionnaire-8
brief depression measure; Change over time is being assessed.
Measured: baseline, 6 week, 6 month
Anxiety Sensitivity Index
Change over time is being assessed.
Measured: baseline, 6 week, 6 month
Panic Disorder Severity Scale
Change over time is being assessed.
Measured: baseline, 6 week, 6 month
Social Phobia Inventory
Change over time is being assessed.
Measured: baseline, 6 week, 6 month
Penn State Worry Questionnaire
Change over time is being assessed.
Measured: baseline, 6 week, 6 month
Posttraumatic Stress Disorder Checklist
Change over time is being assessed.
Measured: baseline, 6 week, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study start15 Nov 2013
- Primary completion15 Nov 2016
- Study completion15 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kate Taylor, University of California, Los Angeles
- Investigators
- Kate B Taylor, Ph.D., Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764698
- Sponsor's protocol ID
- 7K23DA031677
- Status last verified
- Oct 2017
- First submitted
- 17 Dec 2012
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29852309Wolitzky-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.
PubMed 29300100
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of CALM for Comorbid Anxiety and Substance Use Disorders
- ClinicalTrials.gov ID
- NCT01764698
- Acronym / sponsor ID
- 7K23DA031677
- Conditions
- Anxiety Disorders, Substance Use Disorders
- Keywords
- anxiety disorders, substance use disorders, treatment effectiveness, cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 15 Nov 2013 (actual)
- Primary completion
- 15 Nov 2016 (actual)
- Study completion
- 15 Nov 2016 (actual)
- First posted
- 9 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CALM-SUD | Experimental | Behavioral: CALM-SUDParticipants 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. |
| Treatment as usual | Active comparator | Behavioral: Treatment as usualParticipants in this arm receive the standard Intensive Outpatient treatment for their substance use disorder at a community addictions treatment facility. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- have unstable medical conditions
- marked cognitive impairment
- active suicidal intent or plan
- active psychosis
- unstable Bipolar I disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CALM-SUD6-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. | Behavioural | CALM-SUD |
| Treatment as usualThe 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. | Behavioural | Treatment as usual |
Primary outcome
Brief Symptom Inventory
Time frame: baseline, 6 weeks, 6 months
Change over time is being assessed.
Timeline Follow Back
Time frame: baseline, 6 week, 6 month
Change over time is being assessed
Overall Anxiety Severity and Impairment Scale
Time frame: baseline, 6 week, 6 month
Change over time is being assessed.
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Derived from this study: PubMed 29852309Wolitzky-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.
- Derived from this study: PubMed 29300100Wolitzky-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate B Taylor, Ph.D. principal investigator
University of Southern California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CALM-SUD and Treatment as usual in people with Anxiety Disorders and Substance Use Disorders, run by University of California, Los Angeles at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Symptom Inventory (time frame: baseline, 6 weeks, 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01764698, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.