Trial Outcomes & Findings for Dismantling the Components and Dosing of CBT for Co-Occurring Disorders (NCT NCT02161211)
NCT ID: NCT02161211
Last Updated: 2023-02-15
Results Overview
Relapse status will be assessed using categorical relapse status (yes vs. no). Count is of those who relapsed
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
300 participants
Primary outcome timeframe
4 month follow-up
Results posted on
2023-02-15
Participant Flow
Participant milestones
| Measure |
De-coupling
Six sessions of CBT for anxiety-alcohol de-coupling
De-coupling: Six sessions of CBT for anxiety-alcohol de-coupling
|
Anxiety Reduction
Six sessions of CBT for anxiety reduction.
Anxiety Reduction: Six sessions of CBT for anxiety reduction.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
92
|
94
|
93
|
|
Overall Study
COMPLETED
|
59
|
62
|
63
|
|
Overall Study
NOT COMPLETED
|
33
|
32
|
30
|
Reasons for withdrawal
| Measure |
De-coupling
Six sessions of CBT for anxiety-alcohol de-coupling
De-coupling: Six sessions of CBT for anxiety-alcohol de-coupling
|
Anxiety Reduction
Six sessions of CBT for anxiety reduction.
Anxiety Reduction: Six sessions of CBT for anxiety reduction.
|
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
21
|
27
|
21
|
|
Overall Study
Dropped
|
12
|
5
|
9
|
Baseline Characteristics
Dismantling the Components and Dosing of CBT for Co-Occurring Disorders
Baseline characteristics by cohort
| Measure |
De-coupling
n=92 Participants
Six sessions of CBT for anxiety-alcohol de-coupling
De-coupling: Six sessions of CBT for anxiety-alcohol de-coupling
|
Anxiety Reduction
n=94 Participants
Six sessions of CBT for anxiety reduction.
Anxiety Reduction: Six sessions of CBT for anxiety reduction.
|
Combined
n=93 Participants
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.
|
Total
n=279 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.5 years
n=93 Participants
|
43 years
n=4 Participants
|
38 years
n=27 Participants
|
40 years
n=483 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
105 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=93 Participants
|
58 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
174 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=93 Participants
|
81 Participants
n=4 Participants
|
71 Participants
n=27 Participants
|
234 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
92 participants
n=93 Participants
|
94 participants
n=4 Participants
|
93 participants
n=27 Participants
|
279 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 4 month follow-upRelapse status will be assessed using categorical relapse status (yes vs. no). Count is of those who relapsed
Outcome measures
| Measure |
De-coupling
n=63 Participants
Six sessions of CBT for anxiety-alcohol de-coupling
De-coupling: Six sessions of CBT for anxiety-alcohol de-coupling
|
Anxiety Reduction
n=78 Participants
Six sessions of CBT for anxiety reduction.
Anxiety Reduction: Six sessions of CBT for anxiety reduction.
|
Combined
n=67 Participants
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.
|
|---|---|---|---|
|
Number of Participants That Relapsed to Drinking at 4 Months
|
30 Participants
|
43 Participants
|
35 Participants
|
PRIMARY outcome
Timeframe: 4-monthsNegative binomial regression with offset for possible drinking days exposure in 4 months post treatment
Outcome measures
| Measure |
De-coupling
n=63 Participants
Six sessions of CBT for anxiety-alcohol de-coupling
De-coupling: Six sessions of CBT for anxiety-alcohol de-coupling
|
Anxiety Reduction
n=78 Participants
Six sessions of CBT for anxiety reduction.
Anxiety Reduction: Six sessions of CBT for anxiety reduction.
|
Combined
n=67 Participants
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.
|
|---|---|---|---|
|
Number of Drinking Days in 4 Months Post Treatment
|
8.44 drinking days
Standard Error 1.13
|
13.04 drinking days
Standard Error 1.53
|
11.34 drinking days
Standard Error 1.45
|
PRIMARY outcome
Timeframe: 4 monthsDrinks 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
Outcome measures
| Measure |
De-coupling
n=30 Participants
Six sessions of CBT for anxiety-alcohol de-coupling
De-coupling: Six sessions of CBT for anxiety-alcohol de-coupling
|
Anxiety Reduction
n=43 Participants
Six sessions of CBT for anxiety reduction.
Anxiety Reduction: Six sessions of CBT for anxiety reduction.
|
Combined
n=35 Participants
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.
|
|---|---|---|---|
|
Number of Standard Drinks Per Drinking Day
|
17.17 drinks per drinking day
Standard Error 2.50
|
17.72 drinks per drinking day
Standard Error 2.08
|
17.67 drinks per drinking day
Standard Error 2.31
|
SECONDARY outcome
Timeframe: 4 monthsRelapse to Diagnostic and Statistical Manual (DSM)-IV alcohol dependence criteria based on Structured Clinical Interview for DSM-IV (SCID) at 4 months
Outcome measures
| Measure |
De-coupling
n=63 Participants
Six sessions of CBT for anxiety-alcohol de-coupling
De-coupling: Six sessions of CBT for anxiety-alcohol de-coupling
|
Anxiety Reduction
n=78 Participants
Six sessions of CBT for anxiety reduction.
Anxiety Reduction: Six sessions of CBT for anxiety reduction.
|
Combined
n=67 Participants
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.
|
|---|---|---|---|
|
Number of Participants Who Met SCID-IV Criteria for Alcohol Dependence at 4 Months
|
13 Participants
|
21 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 4 monthsRelapse 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
Outcome measures
| Measure |
De-coupling
n=63 Participants
Six sessions of CBT for anxiety-alcohol de-coupling
De-coupling: Six sessions of CBT for anxiety-alcohol de-coupling
|
Anxiety Reduction
n=78 Participants
Six sessions of CBT for anxiety reduction.
Anxiety Reduction: Six sessions of CBT for anxiety reduction.
|
Combined
n=67 Participants
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.
|
|---|---|---|---|
|
Number of Participants Who Relapsed to Hazardous Drinking
|
27 Participants
|
39 Participants
|
34 Participants
|
Adverse Events
De-coupling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Anxiety Reduction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Combined
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place