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Active, Not Recruiting

NCT Number: NCT03765476

Validation of a Training Program for Patients With Alcohol Use Disorder

This study aims to detect how the Web-based program SALIENCE affects patients with alcohol-use Disorder in terms of craving, cognitive functions and risk of relapse.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Mannheim, Baden-Wurttemberg, 68159, Germany

About this study

In the web-based program SALIENCE ("Stop Alcohol In Everyday life - New Choices and Evaluations") the patient has to make decisions for non-alcoholic and against alcoholic drinks. Therefore there are several scenarios, which are supposed to let the patient integrate these choices into a realistic, everyday life, setting and help the patient to maintain abstinence in upcoming "high risk situations". It has been developed as an add-on therapy to increase the overall outcome.

Participating patients with alcohol-use disorder are to receive an initial screening including questionnaires and neuropsychological tests. Then the patients receive three training sessions with SALIENCE each week.

After three weeks there is another examination. After these three weeks, there is a 90 day period in which there are online follow-ups every two weeks to assess the craving and relapse of the participants. After the 90 day period there is a third examination analog to the first and the second one.

For the first 25 subjects, the follow-up and T3 will be omitted; for this collective, an interim evaluation will be performed after T2 as a pilot study, followed by optimization of the protocol if necessary. The first 25 subjects will all receive SALIENCE; a comparison with standard therapy is not planned for this collective. There will be 2 weeks between T1 and T2 in the pilot study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age between 18 and 65
  • alcohol use disorder (DSM-5)
  • inpatient or part inpatient treatment
  • alcohol abstinence for at least 72 hours and maximum for three weeks
  • normal or correctable eyesight
  • Sufficient ability to communicate with the investigators, to answer questions in oral and written form
  • "Fully Informed Consent"
  • "Written Informed Consent"

Exclusion criteria

  • Withdrawal of the declaration of consent
  • severe internistic, neurological or psychiatric comorbidities
  • severe withdrawal symptoms (CIWA-R > 7)
  • alcohol-intoxication (> 0 ‰)
  • Pharmacotherapy with psychoactive substances within the last 14 days (except Clomethiazole or Benzodiazepines within the alcohol withdrawal treatment; treatment with these medications has to be completed within last 3 days)
  • Axis 1 disorder according to ICD-10 and DSM 5 (except tobacco use disorder and specific phobia within the last 12 months)

Treatment and study plan

Salience

Behavioral

3 computer-based training sessions with program "SALIENCE" per week over 3 weeks (see study description)

TAU

Behavioral

treatment as usual, , i.e. medically supervised detoxification treatment (i.e. medical management of withdrawal symptoms, associated physical discomfort and any co-existing disorders, etc.) as well as health education and supportive therapy sessions.

Primary outcomes

  1. Change in alcohol craving

    Time frame: directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)

    Visual Analogue Scale

  2. Change in attentional bias

    Time frame: directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)

    Dotprobe-Task (MacLeod, Mathews, & Tata, 1986)

  3. Change in alcohol interference

    Time frame: directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)

    Alcohol Stroop Test (Brand, Leichsenring-Driessen, Beblo, Kremer, & Driessen, 2009)

  4. Change in approach-avoidance tendencies

    Time frame: directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)

    Approach Avoidance Task (AAT) (R. W. Wiers et al., 2009)

Secondary outcomes

  1. Relapse

    Time frame: 90 days after study inclusion

    time to first severe relapse

Sponsors and collaborators

Lead sponsor

Central Institute of Mental Health, Mannheim

Other

Registry information

Official study title

Validation of a Computer-based Training Program for Patients With Alcohol Use Disorder

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2018
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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