Trial Outcomes & Findings for Zambia Common Elements Treatment Approach Pilot Study (NCT NCT03966885)

Last Updated: 2022-09-23

Results Overview

AUDIT is a 10-item measure of hazardous alcohol use with possible range of 0-40 (total scale score). Higher scores are associated with more hazardous use.

Recruitment status

TERMINATED

Study phase

Target enrollment

160 participants

Primary outcome timeframe

Baseline and 6 months post-baseline

Results posted on

2022-09-23

Participant Flow

Participant milestones

Participant milestones
Measure	Brief Intervention (BI) 30 minute alcohol brief intervention delivered by lay provider during HIV clinic visit. Brief Intervention: The BI used in the trial combines motivational interviewing skills with cognitive behavioral therapy elements in order to assist clients with self identified substance misuse to begin to consider changing their rates of drinking and drug use. The intervention lasts 30 to 40 minutes and consists of 5 components including: 1) screening 2) identification and information on the impacts of substance misuse 3) talking about change and goal setting 4) understanding the primary reason for drinking 5) skill building with practice and 6) referral for services.	Brief Intervention + CETA 30 minute alcohol brief intervention delivered by lay provider during clinic visit followed by 6-12 weekly sessions of CETA. Brief Intervention: The BI used in the trial combines motivational interviewing skills with cognitive behavioral therapy elements in order to assist clients with self identified substance misuse to begin to consider changing their rates of drinking and drug use. The intervention lasts 30 to 40 minutes and consists of 5 components including: 1) screening 2) identification and information on the impacts of substance misuse 3) talking about change and goal setting 4) understanding the primary reason for drinking 5) skill building with practice and 6) referral for services. Common Elements Treatment Approach (CETA): The Common Elements Treatment Approach, or CETA, is a transdiagnostic psychotherapy based on cognitive behavioral elements for mood, anxiety and trauma related problems, and for alcohol and substance misuse. CETA is based on the fact that most evidence-based mental health treatments (EBTs) consist of similar components. The objective of CETA is to provide a single training in a range of therapy components that are similar across EBTs and to then teach counselors how to design a specific course of treatment for each client based on the client's presenting problems.
Overall Study STARTED	78	82
Overall Study COMPLETED	56	62
Overall Study NOT COMPLETED	22	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Brief Intervention (BI) 30 minute alcohol brief intervention delivered by lay provider during HIV clinic visit. Brief Intervention: The BI used in the trial combines motivational interviewing skills with cognitive behavioral therapy elements in order to assist clients with self identified substance misuse to begin to consider changing their rates of drinking and drug use. The intervention lasts 30 to 40 minutes and consists of 5 components including: 1) screening 2) identification and information on the impacts of substance misuse 3) talking about change and goal setting 4) understanding the primary reason for drinking 5) skill building with practice and 6) referral for services.	Brief Intervention + CETA 30 minute alcohol brief intervention delivered by lay provider during clinic visit followed by 6-12 weekly sessions of CETA. Brief Intervention: The BI used in the trial combines motivational interviewing skills with cognitive behavioral therapy elements in order to assist clients with self identified substance misuse to begin to consider changing their rates of drinking and drug use. The intervention lasts 30 to 40 minutes and consists of 5 components including: 1) screening 2) identification and information on the impacts of substance misuse 3) talking about change and goal setting 4) understanding the primary reason for drinking 5) skill building with practice and 6) referral for services. Common Elements Treatment Approach (CETA): The Common Elements Treatment Approach, or CETA, is a transdiagnostic psychotherapy based on cognitive behavioral elements for mood, anxiety and trauma related problems, and for alcohol and substance misuse. CETA is based on the fact that most evidence-based mental health treatments (EBTs) consist of similar components. The objective of CETA is to provide a single training in a range of therapy components that are similar across EBTs and to then teach counselors how to design a specific course of treatment for each client based on the client's presenting problems.
Overall Study Death	1	0
Overall Study Lost to Follow-up	1	2
Overall Study Not post-assessed. Study ended early due to COVID-19	20	16
Overall Study Moved from study area.	0	2

Baseline Characteristics

Zambia Common Elements Treatment Approach Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brief Intervention (BI) n=78 Participants 30 minute alcohol brief intervention delivered by lay provider during HIV clinic visit. Brief Intervention: The BI used in the trial combines motivational interviewing skills with cognitive behavioral therapy elements in order to assist clients with self identified substance misuse to begin to consider changing their rates of drinking and drug use. The intervention lasts 30 to 40 minutes and consists of 5 components including: 1) screening 2) identification and information on the impacts of substance misuse 3) talking about change and goal setting 4) understanding the primary reason for drinking 5) skill building with practice and 6) referral for services.	Brief Intervention + CETA n=82 Participants 30 minute alcohol brief intervention delivered by lay provider during clinic visit followed by 6-12 weekly sessions of CETA. Brief Intervention: The BI used in the trial combines motivational interviewing skills with cognitive behavioral therapy elements in order to assist clients with self identified substance misuse to begin to consider changing their rates of drinking and drug use. The intervention lasts 30 to 40 minutes and consists of 5 components including: 1) screening 2) identification and information on the impacts of substance misuse 3) talking about change and goal setting 4) understanding the primary reason for drinking 5) skill building with practice and 6) referral for services. Common Elements Treatment Approach (CETA): The Common Elements Treatment Approach, or CETA, is a transdiagnostic psychotherapy based on cognitive behavioral elements for mood, anxiety and trauma related problems, and for alcohol and substance misuse. CETA is based on the fact that most evidence-based mental health treatments (EBTs) consist of similar components. The objective of CETA is to provide a single training in a range of therapy components that are similar across EBTs and to then teach counselors how to design a specific course of treatment for each client based on the client's presenting problems.	Total n=160 Participants Total of all reporting groups
Age, Continuous	41.8 Years STANDARD_DEVIATION 9 • n=5 Participants	38.6 Years STANDARD_DEVIATION 9.4 • n=7 Participants	40.2 Years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	36 Participants n=7 Participants	70 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	46 Participants n=7 Participants	90 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	78 Participants n=5 Participants	82 Participants n=7 Participants	160 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Zambia	78 participants n=5 Participants	82 participants n=7 Participants	160 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months post-baseline

Population: Analysis conducted only among participants with complete data at 6-month follow-up, which include 56 completers out of 78 participants in BI group and 62 completers out of 82 participants in BI + CETA group.

AUDIT is a 10-item measure of hazardous alcohol use with possible range of 0-40 (total scale score). Higher scores are associated with more hazardous use.

Outcome measures

Outcome measures
Measure	Brief Intervention (BI) n=56 Participants 30 minute alcohol brief intervention delivered by lay provider during HIV clinic visit. Brief Intervention (BI): The BI used in the trial combines motivational interviewing skills with cognitive behavioral therapy elements in order to assist clients with self identified substance misuse to begin to consider changing their rates of drinking and drug use. The intervention lasts 30 to 40 minutes and consists of 5 components including: 1) screening 2) identification and information on the impacts of substance misuse 3) talking about change and goal setting 4) understanding the primary reason for drinking 5) skill building with practice and 6) referral for services.	Brief Intervention + CETA n=62 Participants 30 minute alcohol brief intervention delivered by lay provider during clinic visit followed by 6-12 weekly sessions of CETA. Brief Intervention: The BI used in the trial combines motivational interviewing skills with cognitive behavioral therapy elements in order to assist clients with self identified substance misuse to begin to consider changing their rates of drinking and drug use. The intervention lasts 30 to 40 minutes and consists of 5 components including: 1) screening 2) identification and information on the impacts of substance misuse 3) talking about change and goal setting 4) understanding the primary reason for drinking 5) skill building with practice and 6) referral for services. Common Elements Treatment Approach (CETA): The Common Elements Treatment Approach, or CETA, is a transdiagnostic psychotherapy based on cognitive behavioral elements for mood, anxiety and trauma related problems, and for alcohol and substance misuse. CETA is based on the fact that most evidence-based mental health treatments (EBTs) consist of similar components. The objective of CETA is to provide a single training in a range of therapy components that are similar across EBTs and to then teach counselors how to design a specific course of treatment for each client based on the client's presenting problems.
Change in Alcohol Use Disorders Identification Test (AUDIT) Scale Score From Baseline to 6-month Post-baseline.	-10.5 Score on a scale Interval -12.8 to -8.3	-13.7 Score on a scale Interval -15.8 to -11.6

SECONDARY outcome

Timeframe: Baseline and 6 months post-baseline

CES-D is a 20-item scale of depression with a possible range of 0-60 (total scale score). Higher scores are associated with greater depression symptom severity.

Outcome measures

Outcome measures
Measure	Brief Intervention (BI) n=56 Participants 30 minute alcohol brief intervention delivered by lay provider during HIV clinic visit. Brief Intervention (BI): The BI used in the trial combines motivational interviewing skills with cognitive behavioral therapy elements in order to assist clients with self identified substance misuse to begin to consider changing their rates of drinking and drug use. The intervention lasts 30 to 40 minutes and consists of 5 components including: 1) screening 2) identification and information on the impacts of substance misuse 3) talking about change and goal setting 4) understanding the primary reason for drinking 5) skill building with practice and 6) referral for services.	Brief Intervention + CETA n=62 Participants 30 minute alcohol brief intervention delivered by lay provider during clinic visit followed by 6-12 weekly sessions of CETA. Brief Intervention: The BI used in the trial combines motivational interviewing skills with cognitive behavioral therapy elements in order to assist clients with self identified substance misuse to begin to consider changing their rates of drinking and drug use. The intervention lasts 30 to 40 minutes and consists of 5 components including: 1) screening 2) identification and information on the impacts of substance misuse 3) talking about change and goal setting 4) understanding the primary reason for drinking 5) skill building with practice and 6) referral for services. Common Elements Treatment Approach (CETA): The Common Elements Treatment Approach, or CETA, is a transdiagnostic psychotherapy based on cognitive behavioral elements for mood, anxiety and trauma related problems, and for alcohol and substance misuse. CETA is based on the fact that most evidence-based mental health treatments (EBTs) consist of similar components. The objective of CETA is to provide a single training in a range of therapy components that are similar across EBTs and to then teach counselors how to design a specific course of treatment for each client based on the client's presenting problems.
Change in Center for Epidemiological Studies-Depression (CES-D) Scale Score From Baseline to 6-month Post-baseline.	-4.2 Score on a scale Interval -7.2 to -1.1	-8.9 Score on a scale Interval -11.8 to -6.0

SECONDARY outcome

Timeframe: Baseline and 6 months post-baseline

The HTQ is a 39-item PTSD symptom scale with possible range of 1-4 (average scale score). Higher scores are associated with greater PTSD symptom severity.

Outcome measures

Outcome measures
Measure	Brief Intervention (BI) n=56 Participants 30 minute alcohol brief intervention delivered by lay provider during HIV clinic visit. Brief Intervention (BI): The BI used in the trial combines motivational interviewing skills with cognitive behavioral therapy elements in order to assist clients with self identified substance misuse to begin to consider changing their rates of drinking and drug use. The intervention lasts 30 to 40 minutes and consists of 5 components including: 1) screening 2) identification and information on the impacts of substance misuse 3) talking about change and goal setting 4) understanding the primary reason for drinking 5) skill building with practice and 6) referral for services.	Brief Intervention + CETA n=62 Participants 30 minute alcohol brief intervention delivered by lay provider during clinic visit followed by 6-12 weekly sessions of CETA. Brief Intervention: The BI used in the trial combines motivational interviewing skills with cognitive behavioral therapy elements in order to assist clients with self identified substance misuse to begin to consider changing their rates of drinking and drug use. The intervention lasts 30 to 40 minutes and consists of 5 components including: 1) screening 2) identification and information on the impacts of substance misuse 3) talking about change and goal setting 4) understanding the primary reason for drinking 5) skill building with practice and 6) referral for services. Common Elements Treatment Approach (CETA): The Common Elements Treatment Approach, or CETA, is a transdiagnostic psychotherapy based on cognitive behavioral elements for mood, anxiety and trauma related problems, and for alcohol and substance misuse. CETA is based on the fact that most evidence-based mental health treatments (EBTs) consist of similar components. The objective of CETA is to provide a single training in a range of therapy components that are similar across EBTs and to then teach counselors how to design a specific course of treatment for each client based on the client's presenting problems.
Change in Harvard Trauma Questionnaire (HTQ) Post-traumatic Stress Disorder (PTSD) Symptom Scale Score From Baseline to 6-month Post-baseline.	-0.3 Score on a scale Interval -0.5 to -0.1	-0.5 Score on a scale Interval -0.7 to -0.4

SECONDARY outcome

Timeframe: 6 months post-baseline

Any recent substance use will be defined as any use of the following substance types in the past 3 months: inhalants, marijuana, cocaine, amphetamines, sedatives, hallucinogens, opioids.

Outcome measures

Outcome measures
Measure	Brief Intervention (BI) n=56 Participants 30 minute alcohol brief intervention delivered by lay provider during HIV clinic visit. Brief Intervention (BI): The BI used in the trial combines motivational interviewing skills with cognitive behavioral therapy elements in order to assist clients with self identified substance misuse to begin to consider changing their rates of drinking and drug use. The intervention lasts 30 to 40 minutes and consists of 5 components including: 1) screening 2) identification and information on the impacts of substance misuse 3) talking about change and goal setting 4) understanding the primary reason for drinking 5) skill building with practice and 6) referral for services.	Brief Intervention + CETA n=62 Participants 30 minute alcohol brief intervention delivered by lay provider during clinic visit followed by 6-12 weekly sessions of CETA. Brief Intervention: The BI used in the trial combines motivational interviewing skills with cognitive behavioral therapy elements in order to assist clients with self identified substance misuse to begin to consider changing their rates of drinking and drug use. The intervention lasts 30 to 40 minutes and consists of 5 components including: 1) screening 2) identification and information on the impacts of substance misuse 3) talking about change and goal setting 4) understanding the primary reason for drinking 5) skill building with practice and 6) referral for services. Common Elements Treatment Approach (CETA): The Common Elements Treatment Approach, or CETA, is a transdiagnostic psychotherapy based on cognitive behavioral elements for mood, anxiety and trauma related problems, and for alcohol and substance misuse. CETA is based on the fact that most evidence-based mental health treatments (EBTs) consist of similar components. The objective of CETA is to provide a single training in a range of therapy components that are similar across EBTs and to then teach counselors how to design a specific course of treatment for each client based on the client's presenting problems.
Number of Participants With Any Recent Substance Use.	14 Participants	16 Participants

Adverse Events

Brief Intervention (BI)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Brief Intervention + CETA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Brief Intervention (BI) n=78 participants at risk 30 minute alcohol brief intervention delivered by lay provider during HIV clinic visit. Brief Intervention: The BI used in the trial combines motivational interviewing skills with cognitive behavioral therapy elements in order to assist clients with self identified substance misuse to begin to consider changing their rates of drinking and drug use. The intervention lasts 30 to 40 minutes and consists of 5 components including: 1) screening 2) identification and information on the impacts of substance misuse 3) talking about change and goal setting 4) understanding the primary reason for drinking 5) skill building with practice and 6) referral for services.	Brief Intervention + CETA n=82 participants at risk 30 minute alcohol brief intervention delivered by lay provider during clinic visit followed by 6-12 weekly sessions of CETA. Brief Intervention: The BI used in the trial combines motivational interviewing skills with cognitive behavioral therapy elements in order to assist clients with self identified substance misuse to begin to consider changing their rates of drinking and drug use. The intervention lasts 30 to 40 minutes and consists of 5 components including: 1) screening 2) identification and information on the impacts of substance misuse 3) talking about change and goal setting 4) understanding the primary reason for drinking 5) skill building with practice and 6) referral for services. Common Elements Treatment Approach (CETA): The Common Elements Treatment Approach, or CETA, is a transdiagnostic psychotherapy based on cognitive behavioral elements for mood, anxiety and trauma related problems, and for alcohol and substance misuse. CETA is based on the fact that most evidence-based mental health treatments (EBTs) consist of similar components. The objective of CETA is to provide a single training in a range of therapy components that are similar across EBTs and to then teach counselors how to design a specific course of treatment for each client based on the client's presenting problems.
Blood and lymphatic system disorders Anemia	1.3% 1/78 • Number of events 1 • 6 months	0.00% 0/82 • 6 months

Other adverse events

Adverse event data not reported

Additional Information

Jeremy Kane, PhD, MPH

Columbia University

Phone: 7179914098

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place