Alcohol AbusePhase 2NCT01128140
Efficacy Trial of Warrior Check-Up
A Phase 2 study testing Motivational Enhancement Therapy and Education in people with Alcohol Abuse and Alcohol Dependence, run by University of Washington at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Abuse, Alcohol Dependence, Substance Abuse
- What is being tested?
- Motivational Enhancement Therapy and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Sep 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- current abuse or dependence on one or more substances
- not currently enrolled in a counseling program focusing on substance abuse
- currently serving in the Army or other branch of the military.
Who cannot join
- non-fluency in English
- evidence of psychosis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Innovative Programs Research Group
Seattle, Washington, 98105
About this study
Official title: Motivating Treatment Seeking and Behavior Change by Untreated Military Personnel Abusing Alcohol or Drugs
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.
Read the detailed 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.
- Being tested
- Motivational Enhancement Therapy, Education
- Keywords
- motivational enhancement therapy
- Medical subject headings
- Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Enhancement TherapyBehavioural
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.
EducationBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Motivational Enhancement Therapy | Experimental | Not described Receives: Behavioral: Motivational Enhancement Therapy |
| Education | Active comparator | Not described Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Form 90D
Structured interview that uses a timeline follow-back procedure to elicit detailed daily information on the use of alcohol and other drugs.
Measured: 3 months
Inventory of Drug Use Consequences
A 50-item inventory of consequences related to alcohol and drug use.
Measured: 3 months
Treatment Seeking and Preparation Behaviors Questionnaire
Assesses treatment-seeking attitudes, intentions, and behaviors.
Measured: 3 months
Secondary outcomes (2)
Stages of Change Readiness and Treatment Eagerness Scale
19-item questionnaire that assesses readiness to make changes in alcohol or drug use behaviors.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startOct 2010
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Principal investigator, Denise Walker, University of Washington
- Investigators
- Denise D Walker, PhD, Principal investigator, University of Washington School of Social Work
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128140
- Sponsor's protocol ID
- 37278-C
- Status last verified
- May 2015
- First submitted
- 14 May 2010
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rodriguez LM, Neighbors C, Walker D, Walton T. Mechanisms and moderators of intervention efficacy for soldiers with untreated alcohol use disorder. J Consult Clin Psychol. 2020 Feb;88(2):137-148. doi: 10.1037/ccp0000471.
PubMed 31894995
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivating Treatment Seeking and Behavior Change by Untreated Military Personnel Abusing Alcohol or Drugs
- ClinicalTrials.gov ID
- NCT01128140
- Acronym / sponsor ID
- 37278-C
- Keywords
- motivational enhancement therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- Oct 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 21 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Enhancement Therapy | Experimental | Behavioral: Motivational Enhancement Therapy |
| Education | Active comparator | Behavioral: Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- current abuse or dependence on one or more substances
- not currently enrolled in a counseling program focusing on substance abuse
- currently serving in the Army or other branch of the military.
Key exclusion criteria (2 listed)
- non-fluency in English
- evidence of psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Enhancement TherapyMET, 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. | Behavioural | Motivational Enhancement Therapy |
| EducationParticipants 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). | Behavioural | Education |
Primary outcome
Form 90D
Time frame: 3 months
Structured interview that uses a timeline follow-back procedure to elicit detailed daily information on the use of alcohol and other drugs.
Inventory of Drug Use Consequences
Time frame: 3 months
A 50-item inventory of consequences related to alcohol and drug use.
Treatment Seeking and Preparation Behaviors Questionnaire
Time frame: 3 months
Assesses treatment-seeking attitudes, intentions, and behaviors.
2 secondary outcomes
Stages of Change Readiness and Treatment Eagerness Scale
Time frame: 3 months
Drinking Norms Rating Form
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Derived from this study: PubMed 31894995Rodriguez LM, Neighbors C, Walker D, Walton T. Mechanisms and moderators of intervention efficacy for soldiers with untreated alcohol use disorder. J Consult Clin Psychol. 2020 Feb;88(2):137-148. doi: 10.1037/ccp0000471.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise D Walker, PhD principal investigator
University of Washington School of Social Work
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Motivational Enhancement Therapy and Education in people with Alcohol Abuse and Alcohol Dependence, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Form 90D (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01128140, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.