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

NCT03338361 | Completed

• 1 other identifier: EC/2017/1079
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Dependence

Keywords

approach avoidance training; attentional bias training; alcohol depencence; relapse

Outcome Measures

Primary Outcomes (1)

• change in drink behavior

  AUDIT score

  baseline, at 6 months and 1-year post training: change in auditscores between baseline, 6 months and 1-year post-training, and differences between groups

Secondary Outcomes (2)

• change in Retraining attentional bias

  baseline and between 1 and 7 days after completion of the 6 training sessions: change

• change in Retraining action tendencies

  baseline and between 1 and 7 days after completion of the 6 training sessions: change in action tendencies

Other Outcomes (7)

• change in drinking behavior

  baseline; At 3 months post-training: change in audit-c score at baseline and 3 months post training

• Time to first drink

  assessed at 3 months post-training

• Time to first drink

  assessed at 6 months post-training

Study Arms (4)

AAT active - VPT sham

EXPERIMENTAL

Approach avoidance training active intervention and visual probe training sham intervention

Behavioral: active approach avoidance training and sham visual probe training

VPT active - AAT sham

EXPERIMENTAL

Visual probe training active condition and approach avoidance training sham condition

Behavioral: sham approach avoidance training and active visual probe training

AAT active - VPT active

EXPERIMENTAL

Approach avoidance training active condition and visual probe training active condition

Behavioral: active approach avoidance training and active visual probe training

AAT sham - VPT sham

SHAM COMPARATOR

Approach avoidance training sham condition and visual probe training sham condition

Behavioral: sham approach avoidance training and sham visual probe training

Interventions

active approach avoidance training and sham visual probe training BEHAVIORAL

patients receive active AAT training and sham VPT training

AAT active - VPT sham

sham approach avoidance training and active visual probe training BEHAVIORAL

patients receive sham AAT training and active VPT training

VPT active - AAT sham

active approach avoidance training and active visual probe training BEHAVIORAL

patients receive active AAT training and active VPT training

AAT active - VPT active

sham approach avoidance training and sham visual probe training BEHAVIORAL

patients receive sham AAT training and sham VPT training

AAT sham - VPT sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead
• PZ Heilig Hart: collaborator
• PZ Sint-Camillus: collaborator
• University of Amsterdam: collaborator

Study Sites (1)

University Ghent

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Alcoholism; Recurrence

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• sarah C herremans, PhD, MD

  UZ Gent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: November 9, 2017
• Study Start: October 26, 2017
• Primary Completion: February 29, 2020
• Study Completion: February 29, 2020
• Last Updated: December 21, 2021

Record last verified: 2021-12

Locations

BE (1)