Trial Outcomes & Findings for Transdiagnostic CBT for Comorbid Alcohol Use and Anxiety Disorders (NCT NCT03230006)
NCT ID: NCT03230006
Last Updated: 2025-04-09
Results Overview
The Timeline Followback (TLFB) was used to estimate participants' daily drinking during the 90-day period preceding the baseline assessment and was subsequently administered at the beginning of each psychotherapy session and during the follow-up sessions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
Change from baseline following 12-sessions (Take Control Arm), up to 16 weeks, or 16-sessions (Unified Protocol Arm), up to 21 weeks, of treatment.
Results posted on
2025-04-09
Participant Flow
Participant milestones
| Measure |
Unified Protocol
The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) consists of 5 core skills modules based on cognitive behavioral treatment elements of proven effectiveness. As noted above, these core skills modules were designed to target (and have been shown to address) negative emotionality and aversive reactivity to emotional experiences when they occur. These modules are preceded by an introductory session that reviews the patient's presenting symptoms and provides a therapeutic rationale, as well as a module on motivational enhancement. A final module consists of relapse prevention. As the treatment proceeds, the domains of thoughts, feelings, and behaviors are each explored in detail, focusing specifically on elucidating dysfunctional emotion regulation strategies that the patient has developed over time within each of these domains, and teaching patients more adaptive emotion regulation skills.
The UP will be conducted in a standardized fashion, over 16 sessions, following the published therapist guide with minor refinements for application in the proposed comorbid population.
|
Take Control
TC is a psychotherapy platform derived from the National Institute on Alcohol Abuse and Alcoholism's (NIAAA) self-help approach, Rethinking Drinking. In this study, TC, originally designed as a computerized treatment has been modified to be administered by the therapist to control for effects that may be related to patient-therapist interaction (as opposed to elements of the treatment itself). Specifically, over 12 sessions on a weekly basis, therapists will review material from TC and offer general advice on implementation of the alcohol reduction skills in daily life.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
24
|
|
Overall Study
COMPLETED
|
38
|
21
|
|
Overall Study
NOT COMPLETED
|
13
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transdiagnostic CBT for Comorbid Alcohol Use and Anxiety Disorders
Baseline characteristics by cohort
| Measure |
Unified Protocol
n=51 Participants
The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) consists of 5 core skills modules based on cognitive behavioral treatment elements of proven effectiveness. As noted above, these core skills modules were designed to target (and have been shown to address) negative emotionality and aversive reactivity to emotional experiences when they occur. These modules are preceded by an introductory session that reviews the patient's presenting symptoms and provides a therapeutic rationale, as well as a module on motivational enhancement. A final module consists of relapse prevention. As the treatment proceeds, the domains of thoughts, feelings, and behaviors are each explored in detail, focusing specifically on elucidating dysfunctional emotion regulation strategies that the patient has developed over time within each of these domains, and teaching patients more adaptive emotion regulation skills.
The UP will be conducted in a standardized fashion, over 16 sessions, following the published therapist guide with minor refinements for application in the proposed comorbid population.
|
Take Control
n=24 Participants
Take Control (TC) is a psychotherapy platform derived from the National Institute on Alcohol Abuse and Alcoholism's (NIAAA) self-help approach, Rethinking Drinking. In this study, TC, originally designed as a computerized treatment has been modified to be administered by the therapist to control for effects that may be related to patient-therapist interaction (as opposed to elements of the treatment itself). Specifically, on a weekly basis for 12 sessions, therapists will review material from TC and offer general advice on implementation of the alcohol reduction skills in daily life.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.71 Years
n=5 Participants
|
41.83 Years
n=7 Participants
|
43.11 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
24 participants
n=7 Participants
|
75 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline following 12-sessions (Take Control Arm), up to 16 weeks, or 16-sessions (Unified Protocol Arm), up to 21 weeks, of treatment.Population: Analyses were carried out using one-way repeated measures ANOVAs. This type of analysis only includes data from participants who completed treatment, and excludes non-completers.
The Timeline Followback (TLFB) was used to estimate participants' daily drinking during the 90-day period preceding the baseline assessment and was subsequently administered at the beginning of each psychotherapy session and during the follow-up sessions.
Outcome measures
| Measure |
Unified Protocol
n=51 Participants
The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) consists of 5 core skills modules based on cognitive behavioral treatment elements of proven effectiveness. As noted above, these core skills modules were designed to target (and have been shown to address) negative emotionality and aversive reactivity to emotional experiences when they occur (Boswell et al., 2013; Carl et al., 2014; Sauer-Zavala et al., 2012). These modules are preceded by an introductory session that reviews the patient's presenting symptoms and provides a therapeutic rationale, as well as a module on motivational enhancement. A final module consists of relapse prevention. As the treatment proceeds, the domains of thoughts, feelings, and behaviors are each explored in detail, focusing specifically on elucidating dysfunctional emotion regulation strategies that the patient has developed over time within each of these domains, and teaching patients more adaptive emotion regulation skills.
The UP will be conducted in a standardized fashion, over 16 sessions, following the published therapist guide with minor refinements for application in the proposed comorbid population.
|
Take Control
n=24 Participants
TC is a psychotherapy platform derived from the National Institute on Alcohol Abuse and Alcoholism's (NIAAA) self-help approach, Rethinking Drinking. In this study, TC, originally designed as a computerized treatment has been modified to be administered by the therapist to control for effects that may be related to patient-therapist interaction (as opposed to elements of the treatment itself). Specifically, on a weekly basis, for 12 sessions, therapists will review material from TC and offer general advice on implementation of the alcohol reduction skills in daily life.
|
|---|---|---|
|
Mean Number of Drinks Consumed Per Week
Weekly Average Drinks at Baseline
|
40.82 Standard Drinking Units per Week
Standard Deviation 49.07
|
29.62 Standard Drinking Units per Week
Standard Deviation 20.09
|
|
Mean Number of Drinks Consumed Per Week
Weekly Average Drinks at Post-Treatment
|
12.12 Standard Drinking Units per Week
Standard Deviation 10.89
|
23.86 Standard Drinking Units per Week
Standard Deviation 21.54
|
Adverse Events
Unified Protocol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Take Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Todd Farchione
Center for Anxiety and Related Disorders, Boston University
Phone: 6173539610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place