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Completed

NCT Number: NCT00288886

Reinforcement of Abstinence and Continuing Care in Substance Abuse Treatment

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS, Jackson, Mississippi, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Contracting, Prompting and Reinforcement arm

Behavioral

Contracting, prompting and reinforcement of continuing care and abstinence.

Control arm

Behavioral

Routine residential treatment and orientation to continuing care.

Primary outcomes

  1. 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

    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 outcomes

  1. 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

    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.

  2. Days Until First Use of Alcohol or Drugs

    Time frame: Baseline to 12 months

  3. Aftercare Attendance

    Time frame: Assessed at 3-, 6-, 9-, and 12-months

    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)

  4. Self-help Support Group Attendance

    Time frame: Assessed over the past 90 days at 3, 6 and 12 months, and cumulative over 1 year

  5. Days of Substance Abuse (Across the Prior 90 Days)

    Time frame: Assessed at Baseline, 3-, 6-, and 12-month follow-up

  6. Rates of Hospitalization (Across the Prior 90 Days)

    Time frame: Assessed at Baseline, 3-, 6-, and 12-months

    Number of days hospitalized for any reason per the previous 90 days

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Official study title

Reinforcement of Abstinence and Attendance in Substance Abuse Treatment

Important dates

Study start
2007
Primary completion
2009
Study completion
2011
First posted
Feb 8, 2006
Registry last updated
Apr 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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