The Efficacy of Brief Motivational Interviewing for Trauma Patients Related to Alcohol or Other Abuse Drugs. (MOTIVA)

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.

Study Overview

• Status: Unknown
• Conditions: AODD and AODR Disorder
• Intervention / Treatment: Behavioral: Brief Motivational Interview

Detailed Description

Objectives:

1. To determine the efficacy of Brief Motivational Interview against an usual hospital treatment (no psychological treatment) in patients who have suffered an accident under the influence of drugs (1) to reduce risk behaviors and drug consumption and (2) to increase motivation to change behavior and risk perception.
2. To investigate the mediating role of impulsive personality and decision making in the impact of Brief Motivational Interview on reduction of risk driving.
3. To assess the economic viability of the results of Brief Motivational Interview through a cost-utility analysis.

• Study Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Andalucia
    • Granada, Andalucia, Spain, 18000
      • Hospital Virgen de las Nieves

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual 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.
Experimental: Brief Motivational Interview; A Brief Motivational Interviewing will be performed during hospital admission by a psychologist experienced with this intervention.	Behavioral: Brief Motivational Interview; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk behavior	Measure with Short Driver Behaviour Questionnaire (SDBQ) and Domain-Specific Risk-Taking (DOSPERT)	Baseline, month 3.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol and Other Drug consumption	Measure with Timeline Followback (TLFB), Interview for Research on Addictive Behavior (IRAB) and Audit Test.	Baseline, month 3.
Motivation to change	Measure with SOCRATES-8	Baseline, post-intervention, month 3
Risk perception	Risk perception questionnaire, perceived risk of alcohol and drug (EDADES).	Baseline, post-intervention, month 3.
General Health	Measure with SF6D	Baseline, month 3.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk Taking and Impulsive Behavior	Measure with Impulsive Behavior Scale (UPPS-P) and Self-efficacy questionnaire	Baseline, month 3.
Real-life decision making	Iowa Gambling Task (IGT)	Baseline, month 3.

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
• Collaborators: Andaluz Health Service; Universidad de Granada
• Investigators: Principal Investigator: Raquel Vilar, PhD, Universidad de Granada

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: June 6, 2014
• First Submitted That Met QC Criteria: June 6, 2014
• First Posted (Estimate): June 9, 2014

Study Record Updates

• Last Update Posted (Estimate): September 25, 2015
• Last Update Submitted That Met QC Criteria: September 24, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Humans; Motivational Interviewing; Recurrence; Intervention Studies; Adult; Risk Factors; Alcohol Drinking; Substance-Related Disorders; Accident Prevention; Trauma Centers; Wounds and Injuries/epidemiology; Wounds and Injuries/etiology*; Wounds and Injuries/prevention & control*
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: PI 0691-2013; PI-0691-2013 (Other Identifier: JUNTA DE ANDALUCIA)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No