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Working Memory Training in Adults With Substance Abuse and Executive Function Deficits.

Primary Purpose

Substance Abuse, Executive Dysfunction, Anxiety

Status
Unknown status
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Computerized Cogmed working memory training
Treatment as usual
Sponsored by
Örebro Läns Landsting
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Treatment seeking adults with substance abuse and executive function deficits.

Exclusion Criteria:

  • Acute intoxication or abstinence symptoms of any substance.
  • Psychosis.

Sites / Locations

  • Psychiatric Research CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cogmed working memory training

Treatment as usual

Arm Description

30-40 minutes of Cogmed computerized working memory training 3-5 days a week for 5-8 weeks. Every training session consists of a set of visual- and verbal working memory tasks that are trained on during the session.

Treatment as usual can consist of medication, psychotherapy, counseling, and psychological assessment. After a 8 week period participants in this arm well be offered Cogmed working memory training.

Outcomes

Primary Outcome Measures

Change from baseline in substance abuse measured with Substance abuse scales in Adult Self Report (ASR; ASEBA).

Secondary Outcome Measures

Change from baseline in Adult Self Report (ASR; ASEBA) Attention problems scale.
Change from baseline in Adult Self Report (ASR; ASEBA) Internalizing index.
Change from baseline in Adult Self Report (ASR; ASEBA) Externalizing index.
Change from baseline in Adult Self Report (ASR; ASEBA) Adaptive functioning scales.
Change from baseline in Executive functioning measured with Behavior Rating Inventory of Executive Function-Adult (BRIEF-A).
Change from baseline in verbal working memory measured with performance on Digit span.
Change from baseline in visual working memory measured with performance on Span board.
Change from baseline in focused attention measured with performance on Conners Continuous Performance Test-II (CCPT-II).
Change from baseline in vigilance measured with performance on Conners Continuous Performance Test-II (CCPT-II).
Change from baseline in reading speed measured with performance on Reading speed in Diagnostic Reading and Writing Test (DLS; Swedish version).

Full Information

First Posted
February 19, 2014
Last Updated
October 22, 2015
Sponsor
Örebro Läns Landsting
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1. Study Identification

Unique Protocol Identification Number
NCT02068261
Brief Title
Working Memory Training in Adults With Substance Abuse and Executive Function Deficits.
Official Title
Computerized Working Memory Training in Adults With Substance Abuse and Executive Function Deficits: A Randomised Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Örebro Läns Landsting

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effects of a computerized working memory training program on substance abuse, psychosocial functioning, cognitive performance and psychiatric problems in adults with substance abuse and attention problems.
Detailed Description
The primary aim of this study is to examine the effects of 5 weeks of computerized working memory training on substance abuse. Secondary aims are to explore whether effects are mediated by changes in executive functions and/or moderated by personality. Also, effects on measures of psychosocial functioning, depression, anxiety and attention will be explored. Follow-up assessment will be conducted at 6 months post training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Executive Dysfunction, Anxiety, Depression, Antisocial Personality, Reading Disabilities

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cogmed working memory training
Arm Type
Experimental
Arm Description
30-40 minutes of Cogmed computerized working memory training 3-5 days a week for 5-8 weeks. Every training session consists of a set of visual- and verbal working memory tasks that are trained on during the session.
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Treatment as usual can consist of medication, psychotherapy, counseling, and psychological assessment. After a 8 week period participants in this arm well be offered Cogmed working memory training.
Intervention Type
Behavioral
Intervention Name(s)
Computerized Cogmed working memory training
Intervention Description
Computerized working memory training with Cogmed QM software. The QM software consists of a set of verbal and visual working memory tasks which is trained for 25-40 minutes each session.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
Treatment as usual can consist of medication, psychotherapy, counseling, and psychological assessment.
Primary Outcome Measure Information:
Title
Change from baseline in substance abuse measured with Substance abuse scales in Adult Self Report (ASR; ASEBA).
Time Frame
Baseline and at 25 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in Adult Self Report (ASR; ASEBA) Attention problems scale.
Time Frame
Baseline and at 25 weeks
Title
Change from baseline in Adult Self Report (ASR; ASEBA) Internalizing index.
Time Frame
Baseline and at 25 weeks
Title
Change from baseline in Adult Self Report (ASR; ASEBA) Externalizing index.
Time Frame
Baseline and at 25 weeks
Title
Change from baseline in Adult Self Report (ASR; ASEBA) Adaptive functioning scales.
Time Frame
Baseline and at 25 weeks
Title
Change from baseline in Executive functioning measured with Behavior Rating Inventory of Executive Function-Adult (BRIEF-A).
Time Frame
Baseline and at 25 weeks
Title
Change from baseline in verbal working memory measured with performance on Digit span.
Time Frame
Baseline and at 25 weeks
Title
Change from baseline in visual working memory measured with performance on Span board.
Time Frame
Baseline and at 25 weeks
Title
Change from baseline in focused attention measured with performance on Conners Continuous Performance Test-II (CCPT-II).
Time Frame
Baseline and at 25 weeks
Title
Change from baseline in vigilance measured with performance on Conners Continuous Performance Test-II (CCPT-II).
Time Frame
Baseline and at 25 weeks
Title
Change from baseline in reading speed measured with performance on Reading speed in Diagnostic Reading and Writing Test (DLS; Swedish version).
Time Frame
Baseline and at 25 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Treatment seeking adults with substance abuse and executive function deficits. Exclusion Criteria: Acute intoxication or abstinence symptoms of any substance. Psychosis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rickard Ahlberg, doctoral student
Email
rickard.ahlberg@orebroll.se
First Name & Middle Initial & Last Name or Official Title & Degree
Kurt Skårberg, MD
Email
kurt.skarberg@orebroll.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Kjellin, Docent
Organizational Affiliation
Örebro Läns Landsting
Official's Role
Study Director
Facility Information:
Facility Name
Psychiatric Research Centre
City
Örebro
ZIP/Postal Code
701 16
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rickard Ahlberg, doctoral student
Email
rickard.ahlberg@orebroll.se
First Name & Middle Initial & Last Name & Degree
Lars Kjellin, docent

12. IPD Sharing Statement

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Working Memory Training in Adults With Substance Abuse and Executive Function Deficits.

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