GMI-IHMDs: Impact of Group Motivational Interviewing and In-Home-Messaging-Devices for Dually Diagnosed Veterans

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00706901
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Arms: 3
• Actual Duration (Months): 40.9
• Patients Per Site Per Month: 4.4

Study Details

Study Description

Brief Summary

Two approaches for providing evidence-based substance abuse treatment (EBT), group motivational interviewing (GMI) and the In-Home-Messaging-Device (IHMD), are interventions that have the characteristic ability for increasing accessibility to evidence-based treatment among patients with substance use problems and are proposed for investigation. GMI is based on motivational interviewing, an intervention that has shown consistent significant effects in promoting treatment retention and reduced substance use among individuals with substance use disorders, and is delivered in a group format. IHMD is a user-friendly computerized Tele-mental Health communication tool that allows interaction through the telephone line between a Veteran and the health care provider in an individual's home or residential placement. The current proposal aims to determine whether GMI and IHMD lead to a significantly greater increase in treatment engagement and reduction in alcohol use compared to a treatment control condition (TCC) among Veterans with a substance use problem and a co-existing psychiatric disorder.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Dependence; Dual Diagnosis; Drug Dependence	Behavioral: Arm 1 GMI; Behavioral: Arm 2 IHMD; Behavioral: Arm 3 TCC	N/A

Detailed Description

Dually diagnosed Veterans (N = 178) will be recruited from the Charleston, SC VAMC Outpatient Substance Abuse Treatment Center (SATC) and block randomized to TAU, GMI, or IHMD. Patients with alcohol dependence or abuse (including drug abuse) and a nonsubstance-related major Axis I disorder (e.g., bipolar disorder, depression, psychotic disorder) will be eligible for the study. Participants, who were referred to the study at time of triage or during the orientation phase of SATC, will be evaluated at baseline and approximately at a 1 and 3-month follow-up. Primary outcome measures will be alcohol use and treatment utilization as measured by number of days of alcohol use, number of binge alcohol drinking days, and quantity of alcohol consumed (in standard drinks, or SECs), and treatment attendance sessions based on objective CPRS patient medical records (i.e., number of all substance abuse outpatient, other mental health [e.g., PTSD, depression], and other substance abuse treatment sessions), and self-reported 12-step (number of self-help AA/NA) sessions, including days consulting with a 12-step or mutual self-help sponsor. Exploratory outcomes measures include number of illicit drug use days (e.g., cocaine, crack, marijuana, opiates, and sedatives).

Primary questions:

1. Does GMI lead to a significantly greater reduction in alcohol use and an increase in treatment engagement outcomes in the 3-month follow-up period compared to participants assigned to TCC?

Hypothesis: Participants who receive GMI will consume less alcohol and will be engaged in and attend more continuous treatment than participants in TCC in the 3-month follow-up period.

1. Does IHMD lead to a significantly greater reduction in alcohol use and an increase in treatment engagement outcomes in the 3-month follow-up period compared to participants assigned to TCC?

Hypothesis: Participants who receive IHMD will consume less alcohol and will be engaged in and attend more continuous treatment than participants in TCC in the 3-month follow-up period.

Exploratory question:

Compared to TCC, will GMI and IHMD lead to significantly fewer days of illicit drug use by 3-month follow-up?

Hypothesis: Compared to TCC, GMI and IHMD will result in a significant reduction in days of illicit drug use by 3-month follow-up.

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Impact of Group Motivational Interviewing for Dually Diagnosed Veterans
• Actual Study Start Date: May 3, 2010
• Actual Primary Completion Date: Jun 30, 2013
• Actual Study Completion Date: Sep 30, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 GMI Patients randomized to GMI received four structured 75-minute sessions consistent with the central principles and style of motivational interviewing (Miller & Rollnick, 2012). The goal of MI is to develop a sense of discrepancy between personal goals and current behavior and enhance change talk among participants, particularly for taking responsibility of one's substance use and being proactive for remaining in treatment.	Behavioral: Arm 1 GMI; Participants randomized to GMI received four structured, back-to-back, 75-minute sessions in one week consistent with the central principles and spirit of MI (Miller & Rollnick 2013) and based on a manualized protocol (Martino & Santa Ana 2013; Santa Ana & Martino, 2009). Designed for dually diagnosed patients, a focus of the intervention is to examine the relationship between the substance use and the co-existing psychiatric disorder(s) and the importance of proactively treating both conditions.; Behavioral: Arm 3 TCC; TCC consisted of a 4-session psychoeducational group (75 minutes per session). Material was delivered using a power point presentation on topics
Experimental: Arm 2 IHMD Participants randomized to In-Home-Messaging Devices (IHMD) received a 27-day Care Coordination Home Telehealth (CCHT) program targeting their acute recovery from alcohol and other substance use disorder. Participants received their IHMD device through the Charleston VAMC CCHT program, including device accessories and a phone number to reach their CCHT provider. They were provided with specific instructions on how to set up their IHMD in their residence after discharge. The research associate followed-up with the patient one day after receiving the device to ensure that the device was successfully set up and to provide assistance as necessary. Participants received standard VA CCHT services.	Behavioral: Arm 2 IHMD; Participants randomized to IHMD received a 27 day VA Care Coordination Home Telehealth (CCHT) program targeting acute recovery from alcohol and other drug disorders. IHMD consisted of daily assessment combined with dialogues consisting of motivational interviewing, cognitive behavioral therapy, and 12-step (mutual self-help) facilitation.; Behavioral: Arm 3 TCC; TCC consisted of a 4-session psychoeducational group (75 minutes per session). Material was delivered using a power point presentation on topics
Active Comparator: Arm 3 TCC Participants randomized to the Treatment Control Condition (TCC) received a psycho-educational group (e.g., addiction as a chronic disease, relapse prevention, developing a plan to prevent relapse) that was delivered with the aid of sequential standardized PowerPoint presentations. Group members were encouraged to ask questions and make comments. Therapists were encouraged to conduct the sessions using an instructional quality that minimized the use of GMI strategies. TCC consisted of four sessions, lasting 75 minutes, and was conducted on four consecutive days within the course of one week.	Behavioral: Arm 3 TCC; TCC consisted of a 4-session psychoeducational group (75 minutes per session). Material was delivered using a power point presentation on topics

Outcome Measures

Primary Outcome Measures

1. Number of Alcohol Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days [One month follow-up and three month follow up in the previous 30 (one month follow up) and 60 (three month follow up) days]

   Number of alcohol drinking days is the number of days that that participant self-reported having at least 1 standard alcohol beverage during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).

2. Number of Alcohol Binge Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days [One and three-months post intervention in the previous 30 (one month follow up) and 60 (three month follow up) days]

   Number of alcohol binge drinking days is the number of days that that participant self-reported having at least 4 standard alcohol beverages on one occasion (for women) and at least 5 standard alcohol beverages on one occasion (for men) during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).

3. Standard Number of Alcohol Drinks in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days [One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days]

   Standard drinks, or SECs, is the number of drinks that the participant self-reported consuming (as measured by 0.5 oz ethanol alcohol per beverage) during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).

4. Treatment Utilization in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days [One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days]

   Treatment utilization is the number of treatment attendance sessions based on objective CPRS medical records, including number of all VA substance abuse outpatient, other mental health (e.g., PTSD, depression), and other substance abuse treatment sessions.

5. Treatment Attendance at 12-step or Mutual Self-help Sessions in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days [One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days]

   Number of self-reported 12-step (number of self-help alcoholics anonymous or narcotics anonymous [AA/NA]) sessions, including days of consulting with a 12-step sponsor for help with a substance use problem based on the Time Line Follow-Back (Sobell & Sobell, 1992).

Secondary Outcome Measures

1. Number of Illicit Drug Use Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days [One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days]

   Number of illicit drug use days is the number of days that that participant self-reported having used illicit drug (e.g., cocaine, crack, marijuana, opiates, sedatives, hallucinogens) during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ability to provide informed consent

• reading level at least at the 5th grade level

• ability to identify at least one collateral contact

• ability to be contacted by telephone at follow-up

• access to a working telephone line in the home or residential placement

• alcohol use or alcohol and drug use in the 28 days prior to hospitalization and current alcohol dependence (or abuse) or alcohol and drug abuse

Exclusion Criteria:

• auditory or visual impairment that would interfere with study procedures

• scheduled for discharge within 72 hours of initial screening

• diagnosis of dementia

• inability to speak or understand English

• unable to access a landline telephone for the IHMD treatment group

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ralph H. Johnson VA Medical Center, Charleston, SC	Charleston	South Carolina	United States	29401-5799

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Elizabeth J. Santa Ana, PhD MA BA, Ralph H. Johnson VA Medical Center, Charleston, SC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00706901
• Other Study ID Numbers: CDA-2-016-08S; IIR 13-317-2
• First Posted: Jun 30, 2008
• Last Update Posted: Aug 8, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: MI; IHMD
• Additional relevant MeSH terms: Alcoholism; Substance-Related Disorders

Study Results

Participant Flow

Arm/Group Title	Arm 1 GMI	Arm 2 IHMD	Arm 3 TCC
Arm/Group Description	Participants in GMI first completed a baseline assessment, then returned 1 week later to attend four GMI sessions, each session lasting 75 minutes, administered on four consecutive days within the same week period. One and three months after the day of IRB consent, participants were provided 1 one-month and a 3-month follow-up, respectively.	Participants in IHMD first completed a baseline assessment, then received within a 1 week period their IHMD CCHT device to be used on a daily basis for 27 days in their home. One and three months after the day of IRB consent, participants were provided 1 one-month and a 3-month follow-up, respectively.	Participants in TCC first completed a baseline assessment, then returned 1 week later to attend four TCC sessions, each session lasting 75 minutes, administered on four consecutive days within the same week period. One and three months after the day of IRB consent, participants were provided 1 one-month and a 3-month follow-up, respectively.
Period Title: Overall Study
STARTED	59	62	59
COMPLETED	51	57	51
NOT COMPLETED	8	5	8

Baseline Characteristics

Arm/Group Title	Arm 1 GMI	Arm 2 IHMD	Arm 3 TCC	Total
Arm/Group Description	Group Motivational Interviewing	In-Home-Messaging Device	Treatment Control condition	Total of all reporting groups
Overall Participants	59	62	59	180
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.9 (8.8)	52.3 (10.3)	51.1 (10.6)	52.1 (9.9)
Sex: Female, Male (Count of Participants)
Female	5 8.5%	4 6.5%	5 8.5%	14 7.8%
Male	54 91.5%	58 93.5%	54 91.5%	166 92.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	32 54.2%	36 58.1%	36 61%	104 57.8%
White	27 45.8%	25 40.3%	22 37.3%	74 41.1%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 1.6%	1 1.7%	2 1.1%
Region of Enrollment (participants) [Number]
United States	59 100%	62 100%	59 100%	180 100%

Outcome Measures

1. Primary Outcome

Title	Number of Alcohol Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Description	Number of alcohol drinking days is the number of days that that participant self-reported having at least 1 standard alcohol beverage during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).
Time Frame	One month follow-up and three month follow up in the previous 30 (one month follow up) and 60 (three month follow up) days

Outcome Measure Data

Analysis Population Description

Intent to treat population (at least one GMI session attended)

Arm/Group Title	Arm 1 GMI	Arm 2 IHMD	Arm 3 TCC
Arm/Group Description	Group Motivational Interviewing	In Home Messaging Device	Treatment Control Condition
Measure Participants	59	62	59
One month follow up	5.1 (7.6)	6.5 (9.5)	6.7 (10.3)
Three month follow up	8.8 (13.3)	10.9 (16.3)	9.9 (18.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1 GMI, Arm 3 TCC
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Zero-inflated Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Zero inflated Poisson model
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Arm 2 IHMD, Arm 3 TCC
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	zero-hurdle Poisson model
	Comments

2. Primary Outcome

Title	Number of Alcohol Binge Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Description	Number of alcohol binge drinking days is the number of days that that participant self-reported having at least 4 standard alcohol beverages on one occasion (for women) and at least 5 standard alcohol beverages on one occasion (for men) during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).
Time Frame	One and three-months post intervention in the previous 30 (one month follow up) and 60 (three month follow up) days

Outcome Measure Data

Analysis Population Description

Intent to treat population (at least one GMI session attended)

Arm/Group Title	Arm 1 GMI	Arm 2 (IHMD)	Arm 3 TCC
Arm/Group Description	Group Motivational Interviewing	In-Home-Messaging-Device	Treatment Control Condition
Measure Participants	59	62	59
One month follow up	3.1 (6.5)	2.7 (6.5)	6.1 (10.5)
Three month follow up	5.1 (10.8)	4.0 (10.5)	7.9 (17.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1 GMI, Arm 3 TCC
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Zero-inflated Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Zero inflated Poisson model
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Arm 2 IHMD, Arm 3 TCC
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.
Statistical Test of Hypothesis	p-Value	.0002
	Comments
	Method	Zero-hurdle Poisson model
	Comments

3. Primary Outcome

Title	Standard Number of Alcohol Drinks in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Description	Standard drinks, or SECs, is the number of drinks that the participant self-reported consuming (as measured by 0.5 oz ethanol alcohol per beverage) during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).
Time Frame	One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days

Outcome Measure Data

Analysis Population Description

Intent to treat population (at least one GMI session attended)

Arm/Group Title	Arm 1 GMI	Arm 2 (IHMD)	Arm 3 TCC
Arm/Group Description	Group Motivational Interviewing	In-Home-Messaging-Device	Treatment Control Condition
Measure Participants	59	62	59
One month follow up	45.1 (98.1)	45.8 (100.7)	70.0 (131.1)
Three month follow up	66.5 (156.6)	64.6 (129.7)	112.3 (251.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1 GMI, Arm 3 TCC
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	To examine differences between GMI and TCC on SECs, a two-component Weibull mixture model for effectively dealing with zero-heavy continuous data was conducted.
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	Weibull mixture model
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Arm 2 IHMD, Arm 3 TCC
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A generalized linear mixed model with correlated errors to account for correlation between repeated measurements of the response within subjects was conducted.
Statistical Test of Hypothesis	p-Value	0.47
	Comments
	Method	Mixed Models Analysis
	Comments

4. Primary Outcome

Title	Treatment Utilization in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Description	Treatment utilization is the number of treatment attendance sessions based on objective CPRS medical records, including number of all VA substance abuse outpatient, other mental health (e.g., PTSD, depression), and other substance abuse treatment sessions.
Time Frame	One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days

Outcome Measure Data

Analysis Population Description

Intent to treat population (at least one GMI session attended)

Arm/Group Title	Arm 1 GMI	Arm 2 (IHMD)	Arm 3 TCC
Arm/Group Description	Group Motivational Interviewing	In-Home-Messaging-Device	Treatment Control Condition
Measure Participants	59	62	59
One month follow up	8.7 (8.7)	7.0 (9.6)	8.8 (9.0)
Three month follow up	11.3 (13.2)	6.4 (9.8)	8.3 (11.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1 GMI, Arm 3 TCC
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Zero inflated Poisson model with random intercept to account for correlation between repeated measurement of the responses within subjects was conducted.
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Zero inflated Poisson model
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Arm 2 IHMD, Arm 3 TCC
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	Zero-hurdle Poisson model
	Comments

5. Primary Outcome

Title	Treatment Attendance at 12-step or Mutual Self-help Sessions in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Description	Number of self-reported 12-step (number of self-help alcoholics anonymous or narcotics anonymous [AA/NA]) sessions, including days of consulting with a 12-step sponsor for help with a substance use problem based on the Time Line Follow-Back (Sobell & Sobell, 1992).
Time Frame	One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days

Outcome Measure Data

Analysis Population Description

Intent to treat population (at least one GMI session attended)

Arm/Group Title	Arm 1 GMI	Arm 2 (IHMD)	Arm 3 TCC
Arm/Group Description	Group Motivational Interviewing	In-Home-Messaging-Device	Treatment Control Condition
Measure Participants	59	62	59
One month follow up	8.0 (12.0)	5.1 (8.8)	7.1 (29.6)
Three month follow up	16.2 (22.4)	10.6 (16.6)	16.2 (22.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1 GMI, Arm 3 TCC
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Zero inflated Poisson model with random intercept to account for correlation between repeated measurement of the responses within subjects was conducted.
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	Zero inflated Poisson model
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Arm 2 IHMD, Arm 3 TCC
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	Zero-hurdle Poisson model
	Comments

6. Secondary Outcome

Title	Number of Illicit Drug Use Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Description	Number of illicit drug use days is the number of days that that participant self-reported having used illicit drug (e.g., cocaine, crack, marijuana, opiates, sedatives, hallucinogens) during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).
Time Frame	One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days

Outcome Measure Data

Analysis Population Description

Intent to treat population (at least one GMI session attended)

Arm/Group Title	Arm 1 GMI	Arm 2 (IHMD)	Arm 3 TCC
Arm/Group Description	Group Motivational Interviewing	In-Home-Messaging-Device	Treatment Control Condition
Measure Participants	59	62	59
One month follow up	0.74 (1.6)	0.62 (2.3)	0.7 (1.6)
Three month follow up	0.9 (2.0)	0.51 (1.6)	0.7 (2.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1 GMI, Arm 3 TCC
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Zero inflated Poisson model with random intercept to account for correlation between repeated measurement of the responses within subjects was conducted.
Statistical Test of Hypothesis	p-Value	0.17
	Comments
	Method	Zero inflated Poisson model
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Arm 2 IHMD, Arm 3 TCC
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.
Statistical Test of Hypothesis	p-Value	0.67
	Comments
	Method	Zero-hurdle Poisson model
	Comments

Adverse Events

Arm/Group Title	Arm 1 GMI		Arm 2 IHMD		Arm 3 TCC
Arm/Group Description	Group Motivational Interviewing		In Home Messaging Device		Treatment Control Condition
All Cause Mortality
	Arm 1 GMI		Arm 2 IHMD		Arm 3 TCC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1 GMI		Arm 2 IHMD		Arm 3 TCC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/59 (3.4%)		0/62 (0%)		0/59 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death due to throat cancer	1/59 (1.7%)	59	0/62 (0%)	0	0/59 (0%)	0
Psychiatric disorders
Suicidal Ideation	1/59 (1.7%)	59	0/62 (0%)	0	0/59 (0%)	0
Other (Not Including Serious) Adverse Events
	Arm 1 GMI		Arm 2 IHMD		Arm 3 TCC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.