NCT02119949

Brief Summary

Background: Substance abusers show impaired working memory (WM) functioning. Promising findings show training WM results in an improved working memory capacity (WMC) and a decrease of clinical symptoms in a range of disorders, including alcohol addiction. Aim: To test the effect of a WM training in addition to treatment as usual (TAU) on substance use, craving, WMC, impulsivity, attention bias and psychopathology. Design: A randomized double-blind placebo-controlled trial with a parallel group design. The WM training adapted to participants' WMC whereas the placebo training consisted of non-adaptive easy versions of these tasks. Setting: Two departments of an addiction treatment clinic in Rotterdam, the Netherlands. Participants: 120 inpatients diagnosed with an alcohol, cannabis or cocaine dependency who were in treatment as usual . Measurements: Primary outcome measures: Substance use and craving. Secondary outcome measures: WMC, impulsivity, attention bias and psychopathology. Participants were assessed before and after 24 sessions of WM training as well as two months after the training.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 22, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

August 21, 2014

Status Verified

August 1, 2014

Enrollment Period

2.1 years

First QC Date

April 8, 2014

Last Update Submit

August 20, 2014

Conditions

Keywords

Substance abuseAddictionWorking memoryCravingImpulsivityAttention control

Outcome Measures

Primary Outcomes (1)

  • Craving: Desires for Alcohol Questionnaire and Desires for Drug Questionnaire score change and Obsessive Compulsive Drug Use Scale and Obsessive Compulsive Drinking Scale score change between pre and post training and follow up (two months after post)

    The 14-item Desires for Drug Questionnaire (DDQ) and the 13-item Desires for Alcohol Questionnaire (DAQ) measure instant craving to respectively drug and alcohol. The DDQ is based on the DAQ. The Obsessive Compulsive Drug Use Scale (OCDUS) and Obsessive Compulsive Drinking Scale (OCDS) measure the subjective interference and distress caused by respectively drug and alcohol related thoughts and compulsive-behavior patterns.

    Pre (baseline), post (after 4 weeks of training-starting 1 day after pre-test) and follow-up (2 months after post-test)

Secondary Outcomes (2)

  • Change in Digit Span score on pre and post training and follow up after two months

    Pre (baseline), post (after 4 weeks of training-starting 1 day after pre-test) and follow-up (2 months after post-test)

  • Change in Reading Span partial-scredit uni score on pre and post training and follow up after two months

    Pre (baseline), post (after 4 weeks of training-starting 1 day after pre-test) and follow-up (2 months after post-test)

Other Outcomes (5)

  • Change in Barratt Impulsivity Scale-11 score on pre and post training and follow up after two months

    Pre (baseline), post (after 4 weeks of training-starting 1 day after pre-test) and follow-up (2 months after post-test)

  • Change in Stroop score on pre and post training and follow up after two months

    Pre (baseline), post (after 4 weeks of training-starting 1 day after pre-test) and follow-up (2 months after post-test)

  • Change in Beck Depression Inventory - Second Edition (BDI-II) score on pre and post training and follow up after two months

    Pre (baseline), post (after 4 weeks of training-starting 1 day after pre-test) and follow-up (2 months after post-test)

  • +2 more other outcomes

Study Arms (2)

Working memory training

EXPERIMENTAL
Behavioral: Working memory training

Placebo training

PLACEBO COMPARATOR
Behavioral: Placebo training

Interventions

The working memory training started the day after the pre-test and included 24 sessions of 25 minutes each. Participants trained, under supervision of an experimenter, on weekdays in the clinic. The training consisted of two tasks: the Symmetry Span and the N-back Task. Participants in the experimental group executed versions of these task that adapt to their working memory capacity, to train their working memory optimally.

Working memory training

The working memory training started the day after the pre-test and included 24 sessions of 25 minutes each. Participants trained, under supervision of an experimenter, on weekdays in the clinic. The training consisted of two tasks: the Symmetry Span and the N-back Task. Participants in the placebo group executed easy versions of these task that did not adapt to their level, to prevent training.

Placebo training

Eligibility Criteria

Age16 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Substance dependency: cocaine, cannabis or alcohol

You may not qualify if:

  • Age below 16 or above 67
  • Current psychosis
  • Neurological complaints

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bouman Clinic

Rotterdam, South Holland, 3084 LD, Netherlands

Location

MeSH Terms

Conditions

Behavior, AddictiveAnxiety DisordersDepressionSubstance-Related DisordersImpulsive Behavior

Condition Hierarchy (Ancestors)

Compulsive BehaviorBehaviorMental DisordersBehavioral SymptomsChemically-Induced Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 8, 2014

First Posted

April 22, 2014

Study Start

May 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

August 21, 2014

Record last verified: 2014-08

Locations