NCT02159391

Brief Summary

The purpose of this study is to determine whether the Brief Motivational Interview will produce a significantly reduction in risk behavior than usual treatment 3 months after discharge from hospital in people who have survived a traumatism.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 9, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 25, 2015

Status Verified

September 1, 2015

Enrollment Period

1.8 years

First QC Date

June 6, 2014

Last Update Submit

September 24, 2015

Conditions

AODD and AODR Disorder

Keywords

Accident PreventionAlcohol DrinkingSubstance-Related DisordersMotivational InterviewingAdultHumansIntervention StudiesRecurrenceRisk FactorsTrauma CentersWounds and Injuries/epidemiologyWounds and Injuries/etiology*Wounds and Injuries/prevention & control*

Outcome Measures

Primary Outcomes (1)

  • Risk behavior

    Measure with Short Driver Behaviour Questionnaire (SDBQ) and Domain-Specific Risk-Taking (DOSPERT)

    Baseline, month 3.

Secondary Outcomes (4)

  • Alcohol and Other Drug consumption

    Baseline, month 3.

  • Motivation to change

    Baseline, post-intervention, month 3

  • Risk perception

    Baseline, post-intervention, month 3.

  • General Health

    Baseline, month 3.

Other Outcomes (2)

  • Risk Taking and Impulsive Behavior

    Baseline, month 3.

  • Real-life decision making

    Baseline, month 3.

Study Arms (2)

Usual Intervention

NO INTERVENTION

A standard intervention will be performed by nursing staff during hospital admission. Written information about the consequences of driving under the influence of alcohol and/or drugs will be provided. No psychological intervention.

Brief Motivational Interview

EXPERIMENTAL

A Brief Motivational Interviewing will be performed during hospital admission by a psychologist experienced with this intervention.

Behavioral: Brief Motivational Interview

Interventions

Brief Motivational InterviewBEHAVIORAL

The Brief Motivational Interview implies an empathic interviewing style which (i) recognizes, examines and tries to resolve the patient´s ambivalence to facilitate behavioral change, (ii) promotes self-efficacy, (iii) allows flexibility in strategies, including short-term aims to reduce consumption and decrease damage linked to this consumption (like road accidents), (iv) works to reduce the patient's resistances, and (v) provides individualized feedback, if deemed appropriate, to promote recognition of the problem and cognitive restructuring.

Brief Motivational Interview

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Trauma patients who have had: 1) A road crash, 2) A sport injury, 3) Occupational accident.
  • Tested positive on alcohol and/or other abuse drugs tests.

You may not qualify if:

  • Cognitive or brain-damage that prevent assessment and Brief Motivational Interview
  • Psychopathological disorders
  • Residence status that prevents follow-up (residence outside of Spain, homeless).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Virgen de las Nieves

Granada, Andalusia, 18000, Spain

Location

MeSH Terms

Conditions

Alcohol DrinkingSubstance-Related DisordersRecurrenceWounds and Injuries

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorChemically-Induced DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Raquel Vilar, PhD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Experimental Psychology Department

Study Record Dates

First Submitted

June 6, 2014

First Posted

June 9, 2014

Study Start

June 1, 2014

Primary Completion

March 1, 2016

Study Completion

December 1, 2016

Last Updated

September 25, 2015

Record last verified: 2015-09

Locations

ES(1)