CBT Decoupling, CBT Anxiety Reduction, CBT Combined
Conditions
Keywords
alcohol, anxiety
Brief 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.
Interventions
BEHAVIORALDe-coupling
Six sessions of CBT for anxiety-alcohol de-coupling
BEHAVIORALAnxiety Reduction
Six sessions of CBT for anxiety reduction.
BEHAVIORALCombined
Three sessions devoted to anxiety reduction and to anxiety-alcohol de-coupling each.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Relapsed to Drinking at 4 Months | 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 | 4-months | Negative binomial regression with offset for possible drinking days exposure in 4 months post treatment |
| Number of Standard Drinks Per Drinking Day | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Met SCID-IV Criteria for Alcohol Dependence at 4 Months | 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 |
| Number of Participants Who Relapsed to Hazardous Drinking | 4 months | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| De-coupling Six sessions of CBT for anxiety-alcohol de-coupling
De-coupling: Six sessions of CBT for anxiety-alcohol de-coupling | 92 |
| Anxiety Reduction Six sessions of CBT for anxiety reduction.
Anxiety Reduction: Six sessions of CBT for anxiety reduction. | 94 |
| Combined Three sessions devoted to anxiety reduction and to anxiety-alcohol de-coupling each.
Combined: Three sessions devoted to anxiety reduction and to anxiety-alcohol de-coupling each. | 93 |
| Total | 279 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Dropped | 12 | 5 | 9 |
| Overall Study | Lost to Follow-up | 21 | 27 | 21 |
Baseline characteristics
| Characteristic | De-coupling | Total | Combined | Anxiety Reduction |
|---|---|---|---|---|
| Age, Continuous | 38.5 years | 40 years | 38 years | 43 years |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 11 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 17 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 15 Participants | 8 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 82 Participants | 234 Participants | 71 Participants | 81 Participants |
| Region of Enrollment United States | 92 participants | 279 participants | 93 participants | 94 participants |
| Sex: Female, Male Female | 34 Participants | 105 Participants | 35 Participants | 36 Participants |
| Sex: Female, Male Male | 58 Participants | 174 Participants | 58 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 92 | 1 / 94 | 1 / 93 |
| other Total, other adverse events | 0 / 92 | 0 / 94 | 0 / 93 |
| serious Total, serious adverse events | 0 / 92 | 0 / 94 | 0 / 93 |
Outcome results
Primary
Number of Drinking Days in 4 Months Post Treatment
Negative binomial regression with offset for possible drinking days exposure in 4 months post treatment
Time frame: 4-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| De-coupling | Number of Drinking Days in 4 Months Post Treatment | 8.44 drinking days | Standard Error 1.13 |
| Anxiety Reduction | Number of Drinking Days in 4 Months Post Treatment | 13.04 drinking days | Standard Error 1.53 |
| Combined | Number of Drinking Days in 4 Months Post Treatment | 11.34 drinking days | Standard Error 1.45 |
p-value: 0.13395% CI: [-0.64, 0.084]Wald Chi-squared
p-value: 0.56295% CI: [-0.24, 0.44]Wald Chi-squared
Primary
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
Time frame: 4 month follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| De-coupling | Number of Participants That Relapsed to Drinking at 4 Months | 30 Participants |
| Anxiety Reduction | Number of Participants That Relapsed to Drinking at 4 Months | 43 Participants |
| Combined | Number of Participants That Relapsed to Drinking at 4 Months | 35 Participants |
Comparison: Null hypothesis = no difference in frequency in relapse between groupsp-value: 0.673Chi-squared
Primary
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
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| De-coupling | Number of Standard Drinks Per Drinking Day | 17.17 drinks per drinking day | Standard Error 2.5 |
| Anxiety Reduction | Number of Standard Drinks Per Drinking Day | 17.72 drinks per drinking day | Standard Error 2.08 |
| Combined | Number of Standard Drinks Per Drinking Day | 17.67 drinks per drinking day | Standard Error 2.31 |
p-value: 0.982ANOVA
Secondary
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
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| De-coupling | Number of Participants Who Met SCID-IV Criteria for Alcohol Dependence at 4 Months | 13 Participants |
| Anxiety Reduction | Number of Participants Who Met SCID-IV Criteria for Alcohol Dependence at 4 Months | 21 Participants |
| Combined | Number of Participants Who Met SCID-IV Criteria for Alcohol Dependence at 4 Months | 16 Participants |
Comparison: Null hypothesis = no difference in proportion between the groupsp-value: 0.685Chi-squared
Secondary
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
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| De-coupling | Number of Participants Who Relapsed to Hazardous Drinking | 27 Participants |
| Anxiety Reduction | Number of Participants Who Relapsed to Hazardous Drinking | 39 Participants |
| Combined | Number of Participants Who Relapsed to Hazardous Drinking | 34 Participants |
Comparison: Null hypothesis = no significant difference in frequency of hazardous drinking between groupsp-value: 0.608Chi-squared