Network Support for Alcohol Treatment 2

• Sponsor: UConn Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT01129804
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 193
• Location: 1
• Arms: 2
• Duration (Months): 78
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

The Network Support project is part of an ongoing effort to improve treatment for alcohol dependent patients. The Network Support Project is designed to help patients change their social network from one that reinforces drinking behavior to one that reinforces sobriety.

160 patients will be assigned to one of two treatments. Each of the treatments will last 12 weeks. The first is a Network Support (NS) treatment designed to help patients develop new acquaintances and social networks. It is expected that alcohol dependent patients will benefit from increasing their contact with non-drinking people. This NS condition will be compared to a packaged CBT program for alcoholics (PCBT) that is designed to teach a number of skills to help people stop drinking, but does not address social networks per se.

In order to better understand what is happening to the investigators patients, the investigators will be using daily computerized telephone calls to ask about people's experiences. This will be done both before and after treatment. Patients will also be asked to participate in follow-up interviews every 3 months for 2 years following the end of treatment.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Consumption	Behavioral: Coping Skills Training	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 193 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Network Support for Alcohol Treatment: Mechanisms and Effectiveness
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Network Support Network Support treatment is aimed at helping patients change their social support network so that it supports abstinence. In this treatment patients will be encouraged to attend AA meetings and engage in other activities that would involve non-drinkers. These activities would be determined by the patient, with help from the therapist. Patients would learn about methods of avoiding drinking, making new friends, and getting enjoyment from activities other than drinking. In addition patients will learn specific skills intended to help them make new acquaintances and change their circle of friends.	Behavioral: Coping Skills Training; Patients in both treatments will be taught skills to help them keep from drinking.
Active Comparator: Packaged Cognitive-Behavioral Treatment The purpose of Packaged Cognitive-Behavioral Treatment (PCBT) is to train patients in a variety of skills that they can use to keep themselves from drinking.	Behavioral: Coping Skills Training; Patients in both treatments will be taught skills to help them keep from drinking.

Outcome Measures

Primary Outcome Measures

1. Proportion Days Abstinent (PDA) [Every 3 months out to 2 years]

   PDA is based on data collected in each 90-day timeline follow-back assessment of daily drinking. PDA is calculated as the number of days out of 90 in which the patient reported 0 drinks.

Secondary Outcome Measures

1. Social Network Change [assessed every 6 months out to 2 years, mean change over 2 years reported]

   Network Support for Abstinence. Minimum score=0; Maximum score =1. Higher scores indicate greater support for abstinence.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 yo

• meets Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for alcohol dependence

Exclusion Criteria:

• acute medical or psychiatric problems that require inpatient treatment (e.g., acute psychosis, or suicide/homicide risk)

• reading ability below the fifth grade level

• lack of reliable transportation to the treatment site, or excessive commuting distance

• inability to understand English

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Connecticut Health Center	Farmington	Connecticut	United States	06030

Sponsors and Collaborators

• UConn Health
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Mark D Litt, Ph.D., UConn Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mark Litt, Professor, UConn Health
• ClinicalTrials.gov Identifier: NCT01129804
• Other Study ID Numbers: 09-050; R01AA012827
• First Posted: May 25, 2010
• Last Update Posted: Nov 2, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by Mark Litt, Professor, UConn Health: Alcohol dependence; Network Support; Cognitive-behavioral treatment; Relapse prevention; Consequences of drinking; Social network development
• Additional relevant MeSH terms: Alcohol Drinking

Study Results

Participant Flow

Arm/Group Title	Network Support	Packaged Cognitive-Behavioral Treatment
Arm/Group Description	Network Support treatment is aimed at helping patients change their social support network so that it supports abstinence. In this treatment patients will be encouraged to attend AA meetings and engage in other activities that would involve non-drinkers. These activities would be determined by the patient, with help from the therapist. Patients would learn about methods of avoiding drinking, making new friends, and getting enjoyment from activities other than drinking. In addition patients will learn specific skills intended to help them make new acquaintances and change their circle of friends. Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.	The purpose of Packaged Cognitive-Behavioral Treatment (PCBT) is to train patients in a variety of skills that they can use to keep themselves from drinking. Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.
Period Title: Overall Study
STARTED	96	97
COMPLETED	64	66
NOT COMPLETED	32	31

Baseline Characteristics

Arm/Group Title	Network Support	Packaged Cognitive-Behavioral Treatment	Total
Arm/Group Description	Network Support treatment is aimed at helping patients change their social support network so that it supports abstinence. In this treatment patients will be encouraged to attend AA meetings and engage in other activities that would involve non-drinkers. These activities would be determined by the patient, with help from the therapist. Patients would learn about methods of avoiding drinking, making new friends, and getting enjoyment from activities other than drinking. In addition patients will learn specific skills intended to help them make new acquaintances and change their circle of friends. Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.	The purpose of Packaged Cognitive-Behavioral Treatment (PCBT) is to train patients in a variety of skills that they can use to keep themselves from drinking. Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.	Total of all reporting groups
Overall Participants	96	97	193
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	96 100%	97 100%	193 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.2 (11.2)	45.1 (9.8)	46.01 (10.5)
Sex: Female, Male (Count of Participants)
Female	37 38.5%	29 29.9%	66 34.2%
Male	59 61.5%	68 70.1%	127 65.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 3.1%	3 3.1%	6 3.1%
Not Hispanic or Latino	93 96.9%	94 96.9%	187 96.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1%	1 1%	2 1%
Asian	0 0%	1 1%	1 0.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 3.1%	2 2.1%	5 2.6%
White	92 95.8%	93 95.9%	185 95.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	96 100%	97 100%	193 100%

Outcome Measures

1. Primary Outcome

Title	Proportion Days Abstinent (PDA)
Description	PDA is based on data collected in each 90-day timeline follow-back assessment of daily drinking. PDA is calculated as the number of days out of 90 in which the patient reported 0 drinks.
Time Frame	Every 3 months out to 2 years

Outcome Measure Data

Analysis Population Description

Men and women aged 18-65 diagnosed with alcohol use disorder, moderate to severe.

Arm/Group Title	Network Support	Packaged Cognitive-Behavioral Treatment
Arm/Group Description	Network Support treatment is aimed at helping patients change their social support network so that it supports abstinence. In this treatment patients will be encouraged to attend AA meetings and engage in other activities that would involve non-drinkers. These activities would be determined by the patient, with help from the therapist. Patients would learn about methods of avoiding drinking, making new friends, and getting enjoyment from activities other than drinking. In addition patients will learn specific skills intended to help them make new acquaintances and change their circle of friends. Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.	The purpose of Packaged Cognitive-Behavioral Treatment (PCBT) is to train patients in a variety of skills that they can use to keep themselves from drinking. Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.
Measure Participants	96	97
Mean (Standard Deviation) [proportion of days abstinent]	.67 (.33)	.73 (.33)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Network Support, Packaged Cognitive-Behavioral Treatment
	Comments
	Type of Statistical Test	Superiority
	Comments	Longitudinal Linear mixed modeling
Statistical Test of Hypothesis	p-Value	<.04
	Comments	Tested the null hypothesis that slopes of PDA over time would not differ between treatment conditions, as indicated by the significance of the Treatment main effect and Treatment X Time interaction effect, at the level of p < .05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.1
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments
Other Statistical Analysis		Multilevel longitudinal modeling (MLM) with random effects and maximum likelihood estimation (Proc MIXED; SAS Institute, 1999) was used to evaluate the effects of treatment over time for each of the continuously scaled outcome variables described above. The MLM approach was used because it employs maximum likelihood estimation of covariance matrices rather than raw data, allowing us to take advantage of all data collected for anyone randomized to treatment. Each repeated dependent variable was analyzed as a unction of treatment condition, time since intake (in months), and the interaction of treatment condition by time.

2. Secondary Outcome

Title	Social Network Change
Description	Network Support for Abstinence. Minimum score=0; Maximum score =1. Higher scores indicate greater support for abstinence.
Time Frame	assessed every 6 months out to 2 years, mean change over 2 years reported

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Network Support	Packaged Cognitive-Behavioral Treatment
Arm/Group Description	Network Support treatment is aimed at helping patients change their social support network so that it supports abstinence. In this treatment patients will be encouraged to attend AA meetings and engage in other activities that would involve non-drinkers. These activities would be determined by the patient, with help from the therapist. Patients would learn about methods of avoiding drinking, making new friends, and getting enjoyment from activities other than drinking. In addition patients will learn specific skills intended to help them make new acquaintances and change their circle of friends. Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.	The purpose of Packaged Cognitive-Behavioral Treatment (PCBT) is to train patients in a variety of skills that they can use to keep themselves from drinking. Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.
Measure Participants	96	97
Mean (Standard Error) [score on a scale]	.35 (.05)	.30 (.05)

Adverse Events

Time Frame	27 months
Arm/Group Title	Network Support		Packaged Cognitive-Behavioral Treatment
Arm/Group Description	Network Support treatment is aimed at helping patients change their social support network so that it supports abstinence. In this treatment patients will be encouraged to attend AA meetings and engage in other activities that would involve non-drinkers. These activities would be determined by the patient, with help from the therapist. Patients would learn about methods of avoiding drinking, making new friends, and getting enjoyment from activities other than drinking. In addition patients will learn specific skills intended to help them make new acquaintances and change their circle of friends. Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.		The purpose of Packaged Cognitive-Behavioral Treatment (PCBT) is to train patients in a variety of skills that they can use to keep themselves from drinking. Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.
All Cause Mortality
	Network Support		Packaged Cognitive-Behavioral Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/96 (2.1%)		2/97 (2.1%)
Serious Adverse Events
	Network Support		Packaged Cognitive-Behavioral Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	30/96 (31.3%)		35/97 (36.1%)
Nervous system disorders
Increased drinking from baseline	30/96 (31.3%)	30	35/97 (36.1%)	35
Other (Not Including Serious) Adverse Events
	Network Support		Packaged Cognitive-Behavioral Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/96 (5.2%)		5/97 (5.2%)
Psychiatric disorders
Suicidal Ideation	5/96 (5.2%)	5	5/97 (5.2%)	5

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.