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Reinforcement of Abstinence and Continuing Care in Substance Abuse Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00288886
First received: February 6, 2006
Last updated: October 28, 2014
Last verified: October 2014
  Purpose

The Contracts, Prompts, and Social Reinforcement (CPR) intervention was designed to address the continuing care adherence needs of veterans presenting for substance use disorder (SUD) treatment. Final results of our recently completed HSR&D clinical trial suggest CPR meaningfully impacts aftercare adherence and abstinence rates. However, CPR did not impact abstinence rates at earlier follow-up points, other important measures of treatment outcome, or AA/NA support group attendance. Furthermore, the generalizability of CPR to other sites has not been established. Thus, the intervention has been modified and pilot testing of this improved version of CPR, which includes contingent reinforcement of abstinence and improved prompting of AA/NA attendance (CPR+), shows promising results. We are conducting a multi-site randomized clinical trial to examine the effectiveness of CPR+. We recruited 183 veterans seeking residential treatment at the Salem and Jackson VAMCs. Our primary hypothesis is that the CPR group will have higher 1-year abstinence rates compared to the STX group. Our secondary hypotheses are that the CPR will be particularly effective for individuals with co-morbid psychiatric disorders, and that the CPR+ group will remain in AA/NA and in aftercare for a longer duration, have fewer days of substance use, fewer hospitalizations, and lower costs of care. Treatment outcome will be measured 3-, 6-, and 12-months after participants enter treatment and compared to baseline levels. The current study will seek to extend past findings to show longer-term effectiveness of the CPR+ intervention on continuing care adherence and greater impact on treatment outcome. Dissemination and implementation efforts will be ongoing for this brief, inexpensive intervention, which offers an important means to improve participation and outcome for individuals seeking SUD treatment within the VAMC. Data collection and analysis has been completed.


Condition Intervention Phase
Substance Use Disorders
Alcohol Abuse
Alcoholism
Substance Dependence
Substance Abuse
Behavioral: Contracting, Prompting and Reinforcement arm
Behavioral: Control arm
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reinforcement of Abstinence and Attendance in Substance Abuse Treatment

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Abstinence Rate (During the Preceding 90 Days) at 12 Months Follow-up Point as Assessed by the Form-90 [ Time Frame: Assessed at 12 months ] [ Designated as safety issue: No ]
    Participants who were abstinent was assessed via Form-90 Interview (Form 90I) is a structured interview that assesses substance use and related behaviors over the previous 90 days employing a calendar-based follow-back method that provides continuous measures of substance use, and has good reliability. Measures include days abstinent, days using alcohol, days using drugs, total number of standard drinks, and days of self help meeting attendance. Briefer versions were constructed to collect data via telephone in instances when participants did not return for in-person interviews. As a reliability check on participants' self-report, a collateral interview was employed when contacting informants. Participants who denied use on the Form-90, but had a positive substance use screen were considered to be not abstinent for that follow-up point.


Secondary Outcome Measures:
  • Abstinence Rate (During the Preceding 90 Days) at 3- and 6-months Follow-up Point as Assessed by the Form-90 [ Time Frame: Assessed at 3 and 6 months ] [ Designated as safety issue: No ]
    Participants who were abstinent was assessed via Form-90 Interview (Form 90I) is a structured interview that assesses substance use and related behaviors over the previous 90 days employing a calendar-based follow-back method that provides continuous measures of substance use, and has good reliability. Measures include days abstinent, days using alcohol, days using drugs, total number of standard drinks, and days of self help meeting attendance. Briefer versions were constructed to collect data via telephone in instances when participants did not return for in-person interviews. As a reliability check on participants' self-report, a collateral interview was employed when contacting informants. Participants who denied use on the Form-90, but had a positive substance use screen were considered to be not abstinent for that follow-up point.

  • Days Until First Use of Alcohol or Drugs [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
  • Aftercare Attendance [ Time Frame: Assessed at 3-, 6-, 9-, and 12-months ] [ Designated as safety issue: No ]
    Measures of aftercare attendance include: Percentage of participants who attended at least 1 aftercare session; percentage of participants who attended at least 2 aftercare sessions/month for at least 3, 6, 9 and 12 months; and percentage of participants who passed the VAMC's SUD continuity of care performance measure (a benchmark for retention of clients in aftercare for at least two visits each month for 3 months following initial treatment)

  • Self-help Support Group Attendance [ Time Frame: Assessed over the past 90 days at 3, 6 and 12 months, and cumulative over 1 year ] [ Designated as safety issue: No ]
  • Days of Substance Abuse (Across the Prior 90 Days) [ Time Frame: Assessed at Baseline, 3-, 6-, and 12-month follow-up ] [ Designated as safety issue: No ]
  • Rates of Hospitalization (Across the Prior 90 Days) [ Time Frame: Assessed at Baseline, 3-, 6-, and 12-months ] [ Designated as safety issue: No ]
    Number of days hospitalized for any reason per the previous 90 days


Enrollment: 183
Study Start Date: March 2007
Study Completion Date: June 2011
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Contracts, Prompts and Reinforcement arm
Participants were provided with contracting, prompting and reinforcement of continuing care attendance and substance use abstinence.
Behavioral: Contracting, Prompting and Reinforcement arm
Contracting, prompting and reinforcement of continuing care and abstinence.
Active Comparator: Control Arm
Participants were provided with routine care- they did not receive contracting, prompting and reinforcement of continuing care attendance and substance use abstinence.
Behavioral: Control arm
Routine residential treatment and orientation to continuing care.

Detailed Description:

The Contracts, Prompts, and Social Reinforcement (CPR) intervention was designed to address the continuing care adherence needs of veterans presenting for substance use disorder (SUD) treatment. Final results of our recently completed HSR&D clinical trial suggest CPR meaningfully impacts aftercare adherence and abstinence rates. Among CPR participants, 55% met the VA's SUD continuity of care performance measure (attending at least 2 therapy sessions each month for 3 months), compared to 36% of those in standard treatment (STX). On the primary outcome variable, 57% of the participants in the CPR condition were abstinent at the 1-year follow-up compared to 37% of those in STX. Post hoc moderator analyses also indicate that the intervention was particularly effective for participants with co-morbid psychiatric disorders. However, CPR did not impact abstinence rates at earlier follow-up points, other important measures of treatment outcome, or AA/NA support group attendance. Furthermore, the generalizability of CPR to other sites has not been established. Thus, the intervention has been modified and pilot testing of this improved version of CPR, which includes contingent reinforcement of abstinence and improved prompting of AA/NA attendance (CPR+), shows promising results. We conducted a multi-site randomized clinical trial to examine the effectiveness of CPR+ with 2 specific goals: 1) to compare CPR+ to STX on adherence to continuing care (i.e., AA/NA participation and aftercare therapy) and 2) to assess its effect on treatment outcome. We recruited 183 veterans seeking residential treatment at the Salem and Jackson VAMCs. Our primary hypothesis is that the CPR group will have higher 1-year abstinence rates compared to the STX group. Our secondary hypotheses are that the CPR will be particularly effective for individuals with co-morbid psychiatric disorders, and that the CPR+ group will remain in AA/NA and in aftercare for a longer duration, have fewer days of substance use, fewer hospitalizations, and lower costs of care. Treatment outcome will be measured 3-, 6-, and 12-months after participants enter treatment and compared to baseline levels using the Form-90 Interview, the Addiction Severity Index (ASI), questionnaire responses, and substance use screens. Treatment adherence will be measured using VA databases, medical records, therapist ratings, and questionnaire responses. Abstinence rates will be analyzed using a logistic regression model in which the parameters of interest are estimated using Generalized Estimating Equations. Secondary outcomes will be analyzed using both marginal and linear mixed-effects models as appropriate. The current study sought to extend past findings to show longer-term effectiveness of the CPR+ intervention on continuing care adherence and greater impact on treatment outcome. Dissemination and implementation efforts are ongoing for this brief, inexpensive intervention, which offers an important means to improve participation and outcome for individuals seeking SUD treatment within the VAMC.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participants were recruited from consecutive veterans who successful complete the 28-day SARRTP at the Salem VAMC and the 21-day SARRTP at the Jackson VAMC. Participants who are uninterested in aftercare, who have unstable housing or other factors that made aftercare participation difficult, will be included to maximize the generalizability of our results.

Exclusion Criteria:

Individuals who did not live within a 60-minute drive, and those who did not have transportation and a work schedule allowing attendance of aftercare were ineligible.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288886

Locations
United States, Mississippi
G.V. (Sonny) Montgomery VA Medical Center
Jackson, Mississippi, United States, 39216
United States, Virginia
VA Medical Center
Salem, Virginia, United States, 24153
Sponsors and Collaborators
Investigators
Principal Investigator: Steven J Lash, PhD Department of Veterans Affairs
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00288886     History of Changes
Other Study ID Numbers: IIR 03-267
Study First Received: February 6, 2006
Results First Received: October 17, 2014
Last Updated: October 28, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Compliance
Aftercare
Reinforcement, social
Alcoholics Anonymous
Support Groups
Treatment Outcome

Additional relevant MeSH terms:
Alcoholism
Substance-Related Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 19, 2014