Spaced Versus Massed Alcohol Avoidance Task

NCT05631366 | Recruiting DMC

• 1 other identifier: NL76667.091.21
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Alcohol-Avoidance Training (AAT) has been used successfully to strengthen avoidance-tendencies in patients with alcohol use disorder (AUD). AAT is already recommended in German clinical treatment guidelines as an evidence-based treatment for AUD and may be incorporated in the next revision of the Dutch clinical guidelines on AUD. Studies in other fields (semantic learning) suggest that spaced learning may be superior to massed learning, but this has not been studied with regard to AAT. Objectives: To compare the effectiveness of spaced versus massed AAT sessions. Study design: a two armed, randomised controlled trail. All participants will receive AAT in addition to routine clinical care in an inpatient setting (Treatment As Usual; TAU). AAT sessions in the experimental group (AAT-S) will be spaced out over four weeks following detoxification. Sessions in the control group (AAT-M) are massed within one week following detoxification. Assessments of alcohol consumption and craving take place before the start of AAT (baseline: T0, timeframe: last 30 days before admission (alcohol use) or past week (craving)) at three (T1) and six months follow-up (T2). Study population: 200 patients with a primary DSM-5 diagnosis of AUD who receive TAU at three addiction care sites (clinical facilities 'Zevenaar', 'Tiel' and 'Wolfheze') of IrisZorg. Patients have finished alcohol detoxification, age ≥ 18, have good Dutch proficiency and have given written informed consent. During the follow-up assessments they are likely to have progressed to regular outpatient addiction treatment. Intervention: During their four week (minimum) admission all participants receive TAU, which includes Community Reinforcement Approach (CRA) (Meyers \& Smith, 1995) grouptraining, AAT, sociotherapy and pharmacotherapy. AAT is a Cognitive Bias Modification paradigm that is used to retrain alcohol approach biases. In AAT participants must react to pictures of alcoholic and non-alcoholic beverages with a joystick to the tilt of the pictures which are presented on a computer screen. In current routine clinical care AAT sessions are massed in the first week after detoxification (control condition: AAT-M). In the experimental condition AAT trails will be spaced out over four weekly sessions instead of one week (AAT-S). Main study parameters/endpoints: Changes from baseline to three and six month follow-up in:

1. 1.Mean daily units of alcohol consumed (past 30 days); at baseline this refers to the 30 days directly pre-admission).
2. 2.Mean ratings of mean alcohol craving (past seven days).

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

• Alcohol consumption

  o Changes in mean units of alcohol consumed in the past 30 days (MATE/MATE - Outcomes (Schippers, Broekman \& Buchholz, 2007) section 1: number of regular drinking days x average number of drinks regular drinking day + number of heavy drinking days x average number of drinks heavy drinking day)

  baseline, three and six 6 month follow-up

Secondary Outcomes (3)

• Alcohol craving

  baseline, three and six 6 month follow-up

• Attentional bias or training effect (manipulation check

  Baseline

• Duration of abstinence

  assessed at three month and six month follow-up

Study Arms (2)

Spaced AAT

ACTIVE COMPARATOR

AAT-S participants will receive 4 AAT sessions totalling 1200 trails but spaced out over four weeks (one AAT session per week)

Behavioral: Alcohol Avoidance Training

Massed AAT

ACTIVE COMPARATOR

AAT-M participants will receive 4 AAT sessions (each with 300 trials) within the space of 8 days (which totals 1200 trails).

Behavioral: Alcohol Avoidance Training

Interventions

Alcohol Avoidance Training BEHAVIORAL

Participants are instructed to react with a joystick to the tilt of pictures, presented on a computer screen. For instance, participants make an approach movement (pull) with left-tilted pictures, and make an avoidance movement (push) with right-tilted pictures. After the correct movement is made, the pictures disappear, otherwise they do not, until the correct response is made.

Massed AAT; Spaced AAT

Eligibility Criteria

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

You may qualify if:

• A primary diagnosis of alcohol use disorder (meeting the DSM-5 criteria (American Psychiatric Association, 2013);
• Age of at least 18 years or older;
• Good Dutch language proficiency;
• Written informed consent.

You may not qualify if:

• Severe, current psychiatric symptoms (especially manic, psychotic, suicidal and aggressive symptoms) that may endanger participants or others and jeopardize study adherence (determined on a case-by-case basis. The staff member who will provide the AAT information, informed consent and instruction will always consult one of the principal investigators in that case).

Sponsors & Collaborators

• W. Markus: lead
• Radboud University Medical Center: collaborator
• Behavioral Science Institute: collaborator
• Nijmegen Institute for Scientist-Practitioners in Addiction (NISPA): collaborator

Study Sites (1)

IrisZorg

Arnhem, Gelderland, 6800 AJ, Netherlands

RECRUITING

Related Publications (1)

• ● Aharonovich, E., Shmulewitz, D., Wall, M. M., Grant, B. F., & Hasin, D. S. (2017). Self-reported cognitive scales in a US national survey: reliability, validity, and preliminary evidence for associations with alcohol and drug use. Addiction, 112(12), 2132-2143. ● Brandon, T. H., Vidrine, J. I., & Litvin, E. B. (2007). Relapse and relapse prevention. Annu. Rev. Clin. Psychol., 3, 257-284. ● Cepeda, N. J., Pashler, H., Vul, E., Wixted, J. T., & Rohrer, D. (2006). Distributed practice in verbal recall tasks: A review and quantitative synthesis. Psychological bulletin, 132(3), 354. ● Cepeda, N. J., Vul, E., Rohrer, D., Wixted, J. T., & Pashler, H. (2008). Spacing effects in learning. Psychological science, 19(11), 1095-1102. ● Domínguez-Salas, S., Díaz-Batanero, C., Lozano-Rojas, O. M., & Verdejo-García, A. (2016). Impact of general cognition and executive function deficits on addiction treatment outcomes. Neuroscience & Biobehavioral Reviews, 71, 772-801. ● Donovan, J. J., & Radosevich, D. J. (1999). A meta-analytic review of the distribution of practice effect: Now you see it, now you don't. Journal of Applied Psychology, 84(5), 795. ● Eberl, C., Wiers, R. W., Pawelczack, S., Rinck, M., Becker, E. S., & Lindenmeyer, J. (2013). Approach bias modification in alcohol dependence: do clinical effects replicate and for whom does it work best?. Developmental Cognitive Neuroscience, 4, 38-51. ● Eberl, C., Wiers, R. W., Pawelczack, S., Rinck, M., Becker, E. S. & Lindenmeyer, J. (2014). Implementation of approach bias re-training in alcoholism - how many sessions are needed? Alcoholism: Clinical and Experimental Research, 38, 2, 587-594. ● Greene, R. L. (1989). Spacing effects in memory: Evidence for a two-process account. Journal of Experimental Psychology: Learning, Memory, and Cognition, 15(3), 371. ● Jacoby, L. L., & Dallas, M. (1981). On the relationship between autobiographical memory and perceptual learning. Journal of Experimental Psychology: General, 110(3), 306. ● Kakoschke, N., Kemps, E., & Tiggemann, M. (2017). Approach bias modification training and consumption. Addictive behaviors, 64, 21-28. ● Manning, V., Staiger, P. K., Hall, K., Garfield, J. B., Flaks, G., Leung, D., ... & Verdejo-Garcia, A. (2016). Cognitive bias modification training during inpatient alcohol detoxification reduces early relapse: a randomized controlled trial. Alcoholism: Clinical and Experimental Research, 40(9), 2011-2019. ● Satpute, A. B. & Lieberman, M. D. (2006). Integrating automatic and controlled processes into neurocognitive models of social cognition. Brain Research, 1079 (1), 86-97. ● Schneider , W. & Chein, J. M. (2003). Controlled & automatic processing: behavior, theory, and biological mechanisms. Cognitive Science, 27, 525-559. ● Sherman, J. W., Gawronski, B., Gonsalkorale, K., Hugenberg, K., Allen, T. J. & Groom, C. J. (2008). The Self-Regulation of Automatic Associations and Behavioral Impulses. Psychological Review, 115(2), 314-335. ● Smith, E. R. & DeCoster, J. (2000). Dual-Process Models in Social and Cognitive Psychology: Conceptual Integration and Links to Underlying Memory Systems. Personality and Social Psychology Review, 4(2), 108-131. ● Stacy, A.W. & Wiers R.W. (2010). Implicit Cognition and Addiction: A Tool for Explaining Paradoxical Behavior. Annu Rev Clin Psychol (6), 551-575. ● Strack, F. & Deutsch, R. (2004). Reflective and Impulsive Determinants of Social Behavior. Personality and Social Psychology Review, 8(3), 220-247. ● Wiers, R.W., Bartholow, B.D., van den Wildenberg, E, Thush, C., Engels, R.C.M.E., Sher, K.J., Grenard, J., Ames, S.L., Stacy, A.W. (2007). Automatic and controlled processes and the development of addictive behaviors in adolescents: a review and a model. Pharmacological Biochemical Behaviour, 86, 263-283. ● Wiers, R.W., Van Woerden, N., Smulders, F.T.Y., De Jong, P.J. (2002): Implicit and explicit alcohol-related cognitions in heavy and light drinkers. Journal of Abnormal Psychology, 111, 648-658. ● Wiers R.W., Eberl, C., Rinck, M., Becker, E.S., & Lindenmeyer, J. (2011). Retraining automatic action tendencies changes alcoholic patients' approach bias for alcohol and improves treatment outcome. [Internet]. Psychological Sciences, 22, 490-497. ● Wiers R.W., Gladwin, T.E., Hofmann, W., Salemink, E., Ridderinkhof, K.R. (2013). Cognitive Bias Modification and Cognitive Control Training in Addiction and Related Psychopathology: Mechanisms, Clinical Perspectives, and Ways Forward. Clinical Psychological Sciences, 1, 192-212. ● Wiers, R. W., Rinck, M., Kordts, R., Houben, K., & Strack, F. (2010). Retraining automatic action-tendencies to approach alcohol in hazardous drinkers. Addiction, 105, 279-287. ● Wiers, R.W., Rinck, M., Dictus, M., & van den Wildenberg, E. (2009). Relatively strong automatic appetitive action-tendencies in male carriers of the OPRM1 G-allele. Genes Brain Behav., 8(1), 101-6.

  BACKGROUND

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Central Study Contacts

Tom Kalisvaart

CONTACT

+31 (0)88 606 1153; t.kalisvaart@iriszorg.nl

Wiebren Markus

CONTACT

+31 (0)6 45 44 67 43; w.markus@iriszorg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. W. Markus, head of research department IrisZorg

Model Details: RCT

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: November 30, 2022
• Study Start: October 8, 2021
• Primary Completion: January 1, 2025
• Study Completion: August 1, 2025
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)