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Working Memory Training for Substance Dependent Individuals

Primary Purpose

Substance Dependency, Addiction, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Working memory training
Placebo training
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Dependency focused on measuring Substance abuse, Addiction, Working memory, Craving, Impulsivity, Attention control

Eligibility Criteria

16 Years - 67 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Substance dependency: cocaine, cannabis or alcohol

Exclusion Criteria:

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

Sites / Locations

  • Bouman Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Working memory training

Placebo training

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Digit Span score on pre and post training and follow up after two months
The Digit Span task consists of two parts: the forward Digit Span is a frequently used measure for short term memory, an important subcomponent of the memory system (Shipstead, Redick, & Engle, 2012) and the backward version measures WM.
Change in Reading Span partial-scredit uni score on pre and post training and follow up after two months
The Reading Span measures the processing and storage functions of WM (Shipstead et al., 2012), specifically participants' ability to shift between two tasks and to cope with proactive interference.

Full Information

First Posted
April 8, 2014
Last Updated
August 20, 2014
Sponsor
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02119949
Brief Title
Working Memory Training for Substance Dependent Individuals
Official Title
A Randomized Double-blind Placebo-controlled Trial to Working Memory Training in Substance Abusers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Dependency, Addiction, Anxiety, Depression
Keywords
Substance abuse, Addiction, Working memory, Craving, Impulsivity, Attention control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Working memory training
Arm Type
Experimental
Arm Title
Placebo training
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Working memory training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Placebo training
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Pre (baseline), post (after 4 weeks of training-starting 1 day after pre-test) and follow-up (2 months after post-test)
Secondary Outcome Measure Information:
Title
Change in Digit Span score on pre and post training and follow up after two months
Description
The Digit Span task consists of two parts: the forward Digit Span is a frequently used measure for short term memory, an important subcomponent of the memory system (Shipstead, Redick, & Engle, 2012) and the backward version measures WM.
Time Frame
Pre (baseline), post (after 4 weeks of training-starting 1 day after pre-test) and follow-up (2 months after post-test)
Title
Change in Reading Span partial-scredit uni score on pre and post training and follow up after two months
Description
The Reading Span measures the processing and storage functions of WM (Shipstead et al., 2012), specifically participants' ability to shift between two tasks and to cope with proactive interference.
Time Frame
Pre (baseline), post (after 4 weeks of training-starting 1 day after pre-test) and follow-up (2 months after post-test)
Other Pre-specified Outcome Measures:
Title
Change in Barratt Impulsivity Scale-11 score on pre and post training and follow up after two months
Description
The 30-item Barratt Impulsivity Scale-11 (BIS-11) measures impulsivity.
Time Frame
Pre (baseline), post (after 4 weeks of training-starting 1 day after pre-test) and follow-up (2 months after post-test)
Title
Change in Stroop score on pre and post training and follow up after two months
Description
The Stroop measures participants' attention bias for addiction related stimuli.
Time Frame
Pre (baseline), post (after 4 weeks of training-starting 1 day after pre-test) and follow-up (2 months after post-test)
Title
Change in Beck Depression Inventory - Second Edition (BDI-II) score on pre and post training and follow up after two months
Description
The Beck Depression Inventory - Second Edition (BDI-II) measures the severity of depression in 21 statements, with four levels of increasing severity each.
Time Frame
Pre (baseline), post (after 4 weeks of training-starting 1 day after pre-test) and follow-up (2 months after post-test)
Title
Change in State-Trait Anxiety Inventory (STAI) score on pre and post training and follow up after two months
Description
The State-Trait Anxiety Inventory (STAI) measures self-reported anxiety in 40 questions on a 4-point scale. The questionnaire consists of two parts; state and trait anxiety, respectively transient and dispositional anxiety.
Time Frame
Pre (baseline), post (after 4 weeks of training-starting 1 day after pre-test) and follow-up (2 months after post-test)
Title
Change in substance use, measured with the Addiction Severity Index over pre-, post (1 day after training) and follow-up (2 months after post-test) measurements.
Description
The Addiction Severity Index (ASI) is a semi-structured interview that measures the severity of addiction in 25 questions concerning seven problem areas: medical problems, employment problems, drug use, alcohol use, family and social problems, criminality, and psychiatric problems. We used three of these questions to assess the severity of participants' abuse problems.
Time Frame
Pre (baseline), post (after 4 weeks of training-starting 1 day after pre-test) and follow-up (2 months after post-test)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Substance dependency: cocaine, cannabis or alcohol Exclusion Criteria: Age below 16 or above 67 Current psychosis Neurological complaints
Facility Information:
Facility Name
Bouman Clinic
City
Rotterdam
State/Province
Zuid Holland
ZIP/Postal Code
3084 LD
Country
Netherlands

12. IPD Sharing Statement

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Working Memory Training for Substance Dependent Individuals

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