CBT DecouplingCBTNCT02161211

Dismantling the Components and Dosing of CBT for Co-Occurring Disorders

A study testing De-coupling, Anxiety Reduction and Combined in people with CBT Decoupling and CBT Anxiety Reduction, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to establish a brief CBT intervention that can largely, if not fully eliminate the deleterious effect of common co-occurring anxiety disorders on alcohol use disorder treatment outcomes. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: CBT Decoupling, CBT Anxiety Reduction, CBT Combined
What is being tested?: De-coupling, Anxiety Reduction and Combined
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 1 siteUnited States
Study dates: Jul 2014to 19 Jun 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

diagnostic and Statistical Manual IV diagnosis of panic disorder, generalized anxiety disorder, and/or social anxiety disorder within the past 30 days;
inpatient treatment at Lodging Plus primarily for alcohol (vs. other drug) dependence
alcohol use in the 30 days preceding the study
ability to provide informed consent
minimum of a sixth grade reading level (deemed necessary to complete study materials);
willingness to provide contact information to confirm study follow-up appointments
lives within proximity to the Twin Cities (e.g., within about an hour's drive) for the purpose attending follow-up visits

Who cannot join

lifetime history of psychosis or mania by history
cognitive or physical impairment that precludes study participation
currently and seriously suicidal (i.e., plan and intent)

Trial locations and contacts

1 site in 1 country.

United States1 site

Lodging Plus Program, Fairview Hospital
Minneapolis, Minnesota, 55454

Other trials in United States

About this study

Conditions: CBT Decoupling, CBT Anxiety Reduction, CBT Combined
Being tested: De-coupling, Anxiety Reduction, Combined
Keywords: alcohol, anxiety
Medical subject headings: Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

De-couplingBehavioural
Six sessions of CBT for anxiety-alcohol de-coupling
Anxiety ReductionBehavioural
Six sessions of CBT for anxiety reduction.
CombinedBehavioural
Three sessions devoted to anxiety reduction and to anxiety-alcohol de-coupling each.

Study groups in NCT02161211
Study group	Role	What they receive
De-coupling	Experimental	Six sessions of CBT for anxiety-alcohol de-coupling Receives: Behavioral: De-coupling
Anxiety Reduction	Experimental	Six sessions of CBT for anxiety reduction. Receives: Behavioral: Anxiety Reduction
Combined	Experimental	Three sessions devoted to anxiety reduction and to anxiety-alcohol de-coupling each. Receives: Behavioral: Combined

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants That Relapsed to Drinking at 4 Months
Relapse status will be assessed using categorical relapse status (yes vs. no). Count is of those who relapsed
Measured: 4 month follow-up
Number of Drinking Days in 4 Months Post Treatment
Negative binomial regression with offset for possible drinking days exposure in 4 months post treatment
Measured: 4-months
Number of Standard Drinks Per Drinking Day
Drinks per drinking day among those who relapsed by 4 months. Standard Drink is defined as 12oz beer, 4ox wine, 3oz fortified wine, 1oz hard liquor
Measured: 4 months

Secondary outcomes (2)

Number of Participants Who Met SCID-IV Criteria for Alcohol Dependence at 4 Months
Relapse to Diagnostic and Statistical Manual (DSM)-IV alcohol dependence criteria based on Structured Clinical Interview for DSM-IV (SCID) at 4 months
Measured: 4 months
Number of Participants Who Relapsed to Hazardous Drinking
Relapse to hazardous drinking (hazardous drinking is defined as 3 or more per occasion for women or more than 7 drinks per week, 4 or more per occasion for men or more than 14 drinks per week) at 4 months
Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 201419 Jun 2020

First posted11 Jun 2014 (estimated)
Study startJul 2014
Primary completion19 Feb 2020
Study completion19 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CBT DecouplingStudies of the same condition, open and under way.
More trials run by University of MinnesotaThe 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: Participant
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02161211
Sponsor's protocol ID: PSYCH-2016-22016
Acronym: CBT
Status last verified: May 2022
First submitted: 9 Jun 2014
Last updated: 15 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dismantling the Components and Dosing of CBT for Co-Occurring Disorders
ClinicalTrials.gov ID: NCT02161211
Acronym / sponsor ID: CBT / PSYCH-2016-22016
Conditions: CBT Decoupling, CBT Anxiety Reduction, CBT Combined
Keywords: alcohol, anxiety
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Study start: Jul 2014 (actual)
Primary completion: 19 Feb 2020 (actual)
Study completion: 19 Jun 2020 (actual)
First posted: 11 Jun 2014 (estimated)
Results: Posted 15 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
De-coupling	Experimental	Behavioral: De-couplingSix sessions of CBT for anxiety-alcohol de-coupling
Anxiety Reduction	Experimental	Behavioral: Anxiety ReductionSix sessions of CBT for anxiety reduction.
Combined	Experimental	Behavioral: CombinedThree sessions devoted to anxiety reduction and to anxiety-alcohol de-coupling each.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

diagnostic and Statistical Manual IV diagnosis of panic disorder, generalized anxiety disorder, and/or social anxiety disorder within the past 30 days;
inpatient treatment at Lodging Plus primarily for alcohol (vs. other drug) dependence
alcohol use in the 30 days preceding the study
ability to provide informed consent
minimum of a sixth grade reading level (deemed necessary to complete study materials);

Key exclusion criteria (3 listed)

lifetime history of psychosis or mania by history
cognitive or physical impairment that precludes study participation
currently and seriously suicidal (i.e., plan and intent)

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
De-couplingSix sessions of CBT for anxiety-alcohol de-coupling	Behavioural	De-coupling
Anxiety ReductionSix sessions of CBT for anxiety reduction.	Behavioural	Anxiety Reduction
CombinedThree sessions devoted to anxiety reduction and to anxiety-alcohol de-coupling each.	Behavioural	Combined

Primary outcome

Number of Participants That Relapsed to Drinking at 4 Months
Time frame: 4 month follow-up
Relapse status will be assessed using categorical relapse status (yes vs. no). Count is of those who relapsed
Number of Drinking Days in 4 Months Post Treatment
Time frame: 4-months
Negative binomial regression with offset for possible drinking days exposure in 4 months post treatment
Number of Standard Drinks Per Drinking Day
Time frame: 4 months
Drinks per drinking day among those who relapsed by 4 months. Standard Drink is defined as 12oz beer, 4ox wine, 3oz fortified wine, 1oz hard liquor

2 secondary outcomes

Number of Participants Who Met SCID-IV Criteria for Alcohol Dependence at 4 Months
Time frame: 4 months
Number of Participants Who Relapsed to Hazardous Drinking
Time frame: 4 months

Results and safety

Results posted to the registry on 15 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
De-coupling	92	59
Anxiety Reduction	94	62
Combined	93	63

Primary outcome: Number of Participants That Relapsed to Drinking at 4 Months

Time frame: 4 month follow-up. Count of participants. Unit: Participants

Measure	De-coupling n = 63	Anxiety Reduction n = 78	Combined n = 67
Value	30	43	35

De-coupling vs Anxiety Reduction vs Combined: p = .673, Chi-squared

Primary outcome: Number of Drinking Days in 4 Months Post Treatment

Time frame: 4-months. Mean (Standard Error). Unit: drinking days

Measure	De-coupling n = 63	Anxiety Reduction n = 78	Combined n = 67
Value	8.44 (1.13)	13.04 (1.53)	11.34 (1.45)

De-coupling vs Combined: Wald Chi-squared: -.278 (95% CI -.64 to .084), p = .133, Wald Chi-squared
Anxiety Reduction vs Combined: Wald Chi-squared: .101 (95% CI -.24 to .44), p = .562, Wald Chi-squared

Primary outcome: Number of Standard Drinks Per Drinking Day

Time frame: 4 months. Mean (Standard Error). Unit: drinks per drinking day

Measure	De-coupling n = 30	Anxiety Reduction n = 43	Combined n = 35
Value	17.17 (2.50)	17.72 (2.08)	17.67 (2.31)

De-coupling vs Combined: p = .982, ANOVA

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through 8 month follow-up. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
De-coupling	0 of 92 (0%)	0 of 92 (0%)	0 of 92
Anxiety Reduction	0 of 94 (0%)	0 of 94 (0%)	1 of 94
Combined	0 of 93 (0%)	0 of 93 (0%)	1 of 93

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Matt Kushner, PhD principal investigator

University of Minnesota

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing De-coupling, Anxiety Reduction and Combined in people with CBT Decoupling and CBT Anxiety Reduction, run by University of Minnesota at 1 site 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 7 inclusion and 3 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 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 15 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants That Relapsed to Drinking at 4 Months (time frame: 4 month follow-up). 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 NCT02161211.

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 15 Feb 2023.