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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01128140
Other study ID # 37278-C
Secondary ID
Status Completed
Phase Phase 2
First received May 14, 2010
Last updated May 26, 2015
Start date October 2010
Est. completion date September 2014

Study information

Verified date May 2015
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This study will develop and test a brief telephone-delivered motivational enhancement intervention for substance abusing military personnel who are not currently in treatment. The hypotheses being tested are that this intervention will prompt a willingness to participate voluntarily in a self-appraisal of substance abuse behavior and consequences, self-initiated change or enrollment in a treatment or self-help program, and cessation of abuse of alcohol or other drugs.


Description:

The health and well-being of military personnel, and consequently the capacity for optimal functioning of military units, are compromised by the abuse of alcohol and/or other drugs. Rates of heavy drinking are higher among military personnel than in the general population and are even higher among recently deployed personnel.

While counseling can be effective, most substance abusers do not tend to voluntarily seek treatment. Moreover, military personnel encounter more real and perceived barriers to seeking treatment.

The substance abuse field is increasingly focusing on developing interventions for those at early stages of readiness to change, i.e., those contemplating but not yet committed to change. A brief, telephone-delivered motivational enhancement intervention (MET) called a "check-up," has shown promise in promoting self-initiated behavior change as well as voluntary treatment entry, enhanced retention, and more successful outcomes for substance abuse.

Adapting the "check-up" for application with military personnel is warranted for three key reasons: (1) it has the potential of overcoming barriers to treatment-seeking, i.e., stigma and apprehension of a negative impact on one's military career; (2) it has the potential of attracting voluntary participation; and (3) protocols for disseminating this low cost intervention for use with deployed military can readily be developed and evaluated.


Recruitment information / eligibility

Status Completed
Enrollment 242
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. current abuse or dependence on one or more substances

2. not currently enrolled in a counseling program focusing on substance abuse

3. currently serving in the Army or other branch of the military.

Exclusion Criteria:

1. non-fluency in English

2. evidence of psychosis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Behavioral:
Motivational Enhancement Therapy
MET, a 30-60 minute telephone session, seeks to increase motivation for change by highlighting inconsistencies between substance use behaviors and beliefs and negative consequences experienced as a result of the behaviors. The counselor will guide the participant in reviewing the Personal Feedback Report (PFR), using MI strategies to elicit the participant's reactions and foster motivation for change. The PFR will show the participant's self-reported alcohol and drug use behavior, consequences of SA, and the participant's perceived and actual descriptive norms for SA behavior. The second phase will target strengthening commitment to change. Counselors will explore with participants the pros and cons of seeking treatment. As the participant verbalizes potential benefits of learning more about treatment, the counselor will use MI skills to encourage elaboration of his/her thinking with the goal of tipping the scale toward a decision to consider taking steps toward treatment.
Education
Participants will receive educational information on the health, psychological, social, and legal consequences of substance abuse. Included in the session will be: legal and behavioral definitions of SA, the social and legal consequences of SA, impact of SA on military duty, a review of the policies on substance use in the military, and treatment resources. The session will be conducted via the telephone and will last from 30-60 minutes. Counselors will present information in a didactic manner and will avoid the use of Motivational Interviewing skills (reflective listening, developing discrepancy, reinforcing participant statements regarding change).

Locations

Country Name City State
United States University of Washington Innovative Programs Research Group Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Form 90D Structured interview that uses a timeline follow-back procedure to elicit detailed daily information on the use of alcohol and other drugs. 3 months No
Primary Inventory of Drug Use Consequences A 50-item inventory of consequences related to alcohol and drug use. 3 months No
Primary Treatment Seeking and Preparation Behaviors Questionnaire Assesses treatment-seeking attitudes, intentions, and behaviors. 3 months No
Secondary Stages of Change Readiness and Treatment Eagerness Scale 19-item questionnaire that assesses readiness to make changes in alcohol or drug use behaviors. 3 months No
Secondary Drinking Norms Rating Form Participant estimates of prevalence and frequency/volume of alcohol/drug consumption by the average person and the average person in the military. 3 months No
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