Research on the Efficacy of the "T.O.P. Computer Training" Procedure in the Treatment of Alcohol Dependence

NCT ID: NCT03338361

Last Updated: 2021-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

247 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-26

Study Completion Date

2020-02-29

Brief Summary

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The investigators evaluate the efficacy of a computerised program (T.O.P. tool) consisting of an approach avoidance training (AAT) (to retrain action tendencies for alcohol-related stimuli), a visual probe training (VPT) (to retrain attentional bias for alcohol-related stimuli) and the combination of both training procedures versus placebo training, as an add-on to treatment as usual (psycho-education and cognitive behavioral therapy).

The investigators include hospitalized detoxified alcohol-dependent patients, who receive a four week training procedure, existing of a pre-assessment, 6 training sessions and a post-assessment.

Outcome measures consist of behavioral measures (consumption of alcohol - self report over 1 year), questionnaires (AUDIT; craving on 9-point likert scale) and approach avoidance and visual probe measurement tasks.

A six month and 1 year follow-up is included (behavioral measures and AUDIT). Further, the investigators will also assess credibility (9-point likert scale) of the training procedure before the start of the training and immediately after the assessment of the AAT and VPT training.

Detailed Description

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Conditions

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Alcohol Dependence

Keywords

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approach avoidance training attentional bias training alcohol depencence relapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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AAT active - VPT sham

Approach avoidance training active intervention and visual probe training sham intervention

Group Type EXPERIMENTAL

active approach avoidance training and sham visual probe training

Intervention Type BEHAVIORAL

patients receive active AAT training and sham VPT training

VPT active - AAT sham

Visual probe training active condition and approach avoidance training sham condition

Group Type EXPERIMENTAL

sham approach avoidance training and active visual probe training

Intervention Type BEHAVIORAL

patients receive sham AAT training and active VPT training

AAT active - VPT active

Approach avoidance training active condition and visual probe training active condition

Group Type EXPERIMENTAL

active approach avoidance training and active visual probe training

Intervention Type BEHAVIORAL

patients receive active AAT training and active VPT training

AAT sham - VPT sham

Approach avoidance training sham condition and visual probe training sham condition

Group Type SHAM_COMPARATOR

sham approach avoidance training and sham visual probe training

Intervention Type BEHAVIORAL

patients receive sham AAT training and sham VPT training

Interventions

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active approach avoidance training and sham visual probe training

patients receive active AAT training and sham VPT training

Intervention Type BEHAVIORAL

sham approach avoidance training and active visual probe training

patients receive sham AAT training and active VPT training

Intervention Type BEHAVIORAL

active approach avoidance training and active visual probe training

patients receive active AAT training and active VPT training

Intervention Type BEHAVIORAL

sham approach avoidance training and sham visual probe training

patients receive sham AAT training and sham VPT training

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* hospitalized alcohol-dependent patients, choosing for abstinence en committed to treatment
* detoxification (with benzodiazepines) is terminated
* Dutch speaking

Exclusion Criteria

* neurological condition, such as Korsakoff syndrome
* cognitive problems (cut-off \<26/30 on the Montral Cognitive Assessment)
* psychotic disorders
* visual and motor problems at the hands
* non-Dutch speaking
* mental retardation
* patients who are illiterate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PZ Heilig Hart

UNKNOWN

Sponsor Role collaborator

PZ Sint-Camillus

UNKNOWN

Sponsor Role collaborator

University of Amsterdam

OTHER

Sponsor Role collaborator

University Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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sarah C herremans, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

UZ Gent

Locations

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University Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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EC/2017/1079

Identifier Type: -

Identifier Source: org_study_id