NCT05489068

Brief Summary

This K23 study is an effectiveness-implementation hybrid type I design to determine the effectiveness of Motivational Interviewing at Intake (MII), relative to intake-as-usual on client engagement and mechanisms of engagement among adults seeking outpatient addiction treatment. We also will obtain personnel feedback on the feasibility of implementing MII into standard practice by having personnel from the addiction treatment study sites complete implementation climate measures before Motivational Interviewing (MI) training and post-clinical trial, as well as an individual interview on implementation feasibility post-trial.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress88%
Mar 2022Dec 2026

Study Start

First participant enrolled

March 16, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 5, 2022

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

4.5 years

First QC Date

July 26, 2022

Last Update Submit

March 5, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Number of participants who attended the first outpatient treatment program session based on electronic medical record review

    Treatment entry is determined by review of electronic medical record of whether clients attended their first scheduled treatment session

    up to 36 weeks

  • Number of treatment sessions attended during the three-month outpatient treatment program based on electronic medical record review

    Number of treatment sessions that clients attend is determined by review of electronic medical record and calculating number of treatment sessions attended.

    up to 36 weeks

  • Number of participants who completed the three-month outpatient treatment program based on electronic medical record review

    Completion of the three-month outpatient treatment program is determined by review of electronic medical record

    up to 36 weeks

Secondary Outcomes (2)

  • Change from baseline in client readiness to enter treatment on the University of Rhode Island Change Assessment Scale (URICA) at 1 hour post-intake

    baseline and 1 hour post-intake

  • Score on therapeutic alliance on the Working Alliance Inventory (WAI) at 1-hour post-intake

    1 hour post-intake

Other Outcomes (3)

  • Change from baseline in organizational readiness to change on the Texas Christian University-Organizational Readiness to Change (TCU-ORC) at 1 year

    baseline and 1 year

  • Change from baseline in organizational readiness to change on the Readiness for Organizational Change (ROC) at 1 year

    baseline and 1 year

  • Change from baseline in organizational capability to change on the Change Process Capability Questionnaire (CPCQ) at Year 1

    baseline and 1 year

Study Arms (2)

Motivational Interviewing at Intake (MII)

EXPERIMENTAL

Clients allocated to the MII condition will receive a 90-minute pure Motivational Interviewing (MI) session.

Behavioral: Motivational Interviewing at Intake (MII)

Intake as Usual (IAU)

ACTIVE COMPARATOR

Clients allocated to the IAU condition will receive the 90-minute standard assessment that is delivered to all clients entering intensive outpatient program (IOP)/outpatient program (OP).

Behavioral: Intake as Usual (IAU)

Interventions

The MII will involve a goal-oriented and collaborative conversation about why the client wants treatment now, and how treatment might fit with his/her most important values. The provider will use open questions, reflective listening and autonomy support in a flexible, non-authoritative manner. Rather than asking specific questions in different life domains, the provider will explore with the client their desires, abilities, reasons, and needs for treatment, how treatment fits with their values, and what successful treatment looks like to them. The client's language about change will be strategically reinforced to increase its frequency and strength across the session.

Motivational Interviewing at Intake (MII)

In line with the American Society of Addiction Medicine (ASAM) guidelines, the IAU condition involves a semi-structured interview of the client's psychosocial history and clients answer a series of questions in the following domains: support system, living situation, educational, occupational, family, and medical history.

Intake as Usual (IAU)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English-speaking adults seeking treatment for alcohol or other drug use at one of two outpatient addiction treatment programs
  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures
  • Physically withdrawn from alcohol or other drugs
  • English-speaking adults currently employed at one of the two outpatient addiction treatment programs
  • Provision of electronic informed consent

You may not qualify if:

  • Experiencing severe withdrawal symptoms
  • Actively psychotic, manic, and/or suicidal
  • current position: facility owner or clinical director

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNM Psychology Clinic

Albuquerque, New Mexico, 87131, United States

RECRUITING

Related Publications (1)

  • Hurlocker MC, Moyers TB, Hatch M, Curran G, McCrady B, Venner KL, Witkiewitz K. Effectiveness and feasibility of a motivational interviewing intake (MII) intervention for increasing client engagement in outpatient addiction treatment: an effectiveness-implementation hybrid design protocol. Addict Sci Clin Pract. 2023 Oct 21;18(1):63. doi: 10.1186/s13722-023-00412-y.

MeSH Terms

Conditions

Substance-Related DisordersTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersHealth BehaviorBehavior

Study Officials

  • Margo Hurlocker, PhD

    University of New Mexico

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Margo Hurlocker, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Effectiveness-Implementation Hybrid Type 1 Design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2022

First Posted

August 5, 2022

Study Start

March 16, 2022

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie results reported in a peer-reviewed publication, after deidentification (text, tables, figures, and appendices). Session audio recordings will not be shared.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will become available starting in January 2025
Access Criteria
Researchers who provide a methodologically sound proposal will have access to the data. A data use agreement will be required, signed by the requesting investigator and their Authorized Organization Representation (AOR)/Signing Official (SO)

Locations