NCT02382042

Brief Summary

Background Participation in continuing care is one of the two most significant factors in preventing relapse after intensive Substance Use Disorder (SUD) treatment.1 A primary component of continuing care, social support, is a protective factor for SUD treatment relapse.2 Social support provided by community self-help groups (e.g. 12-step programs such as Alcoholics Anonymous) improves Substance Use Disorder (SUD) treatment outcomes.1,4 Post-treatment referral to self-help groups was recently described as "an effective, low-cost option,"3 but counselors vary in their referral methods, often simply telling patients to find and attend meetings in their community. In a study of urban veterans leaving treatment, researchers increased 1-year SUD abstinence rates by more than 24% through a three-step intensive referral intervention.5 First, counselors discussed the importance of social support and meeting attendance. Second, counselors identified accessible self-help meetings near the SUD treatment site and arranged for a meeting liaison to accompany the patient to a meeting. Third, counselors followed up on attendance and addressed obstacles. A follow-up study found patients with co-morbid SUD and psychiatric problems significantly benefitted from the intervention.6 The investigators have adapted this intervention so that it can be utilized in a rural as well as urban setting. The investigators have trained clinical staff, measured their fidelity to the intervention and successfully implemented it across three Veteran's Affairs (VA) Substance Use Disorder (SUD) treatment programs (Omaha, Lincoln and Grand Island). In 2012 an intriguing study showed that peer referral to 12-step support groups was significantly more effective than clinician referral.7 This is of particular interest given the scarcity of addiction counselors in rural communities and enhances the intervention's applicability to rural settings and other disciplines. Specific Aim The investigators propose implementing this intervention in a correction population (Intervention Group) and comparing outcomes between the Intervention Group and a group who are receiving standard correction services (Standard Group). Methods Phase I: Adapt Intensive Referral Intervention for correction population Phase II: Train correction staff in Intervention Research staff will train and continue to monitor trained correction staff to ensure fidelity to intervention and provide feedback to staff and leadership regularly. Phase III: Comparison between Intervention Group and Standard Group The two groups will be compared on measures of interest to the Nebraska Department of Correctional Services and on measures of substance use, support group attendance and involvement at standard time points.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

1.8 years

First QC Date

February 23, 2015

Last Update Submit

March 2, 2015

Conditions

Substance Use Disorders

Keywords

Rural HealthVeteransSubstance Abuse

Outcome Measures

Primary Outcomes (1)

  • Sobriety

    Levels of sobriety will be measured by utilizing a time line fall back calendar.This measure outlines when the amount and timeline that a participant has used a particular substance.

    6 months

Study Arms (2)

Intensive Referral Intervention

ACTIVE COMPARATOR
Behavioral: Intensive Referral Intervention

Standard Care

NO INTERVENTION

Interventions

Intensive Referral InterventionBEHAVIORAL
Intensive Referral Intervention

Eligibility Criteria

Age19 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All Veterans in SUD residential and outpatient treatment facilities in Grand Island, Lincoln and Omaha VA sites who are able to provide informed consent will be eligible for this research study.
  • Eligibility to provide informed consent will be determined by completing the MINI-COG, a brief 3-minute instrument to screen for cognitive impairment.

You may not qualify if:

  • If the patient is cognitively impaired, as determined by the MINI-COG, he/she will not be eligible for study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 23, 2015

First Posted

March 6, 2015

Study Start

September 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

March 6, 2015

Record last verified: 2015-03