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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02068261
Other study ID # RA02
Secondary ID
Status Recruiting
Phase Phase 2
First received February 19, 2014
Last updated October 22, 2015
Start date January 2014
Est. completion date December 2016

Study information

Verified date October 2015
Source Örebro Läns Landsting
Contact Rickard Ahlberg, doctoral student
Email rickard.ahlberg@orebroll.se
Is FDA regulated No
Health authority Sweden: The National Board of Health and Welfare
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Acute intoxication or abstinence symptoms of any substance.

- Psychosis.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Behavioral:
Computerized Cogmed working memory training
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.
Treatment as usual
Treatment as usual can consist of medication, psychotherapy, counseling, and psychological assessment.

Locations

Country Name City State
Sweden Psychiatric Research Centre Örebro

Sponsors (1)

Lead Sponsor Collaborator
Örebro Läns Landsting

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in substance abuse measured with Substance abuse scales in Adult Self Report (ASR; ASEBA). Baseline and at 25 weeks No
Secondary Change from baseline in Adult Self Report (ASR; ASEBA) Attention problems scale. Baseline and at 25 weeks No
Secondary Change from baseline in Adult Self Report (ASR; ASEBA) Internalizing index. Baseline and at 25 weeks No
Secondary Change from baseline in Adult Self Report (ASR; ASEBA) Externalizing index. Baseline and at 25 weeks No
Secondary Change from baseline in Adult Self Report (ASR; ASEBA) Adaptive functioning scales. Baseline and at 25 weeks No
Secondary Change from baseline in Executive functioning measured with Behavior Rating Inventory of Executive Function-Adult (BRIEF-A). Baseline and at 25 weeks No
Secondary Change from baseline in verbal working memory measured with performance on Digit span. Baseline and at 25 weeks No
Secondary Change from baseline in visual working memory measured with performance on Span board. Baseline and at 25 weeks No
Secondary Change from baseline in focused attention measured with performance on Conners Continuous Performance Test-II (CCPT-II). Baseline and at 25 weeks No
Secondary Change from baseline in vigilance measured with performance on Conners Continuous Performance Test-II (CCPT-II). Baseline and at 25 weeks No
Secondary Change from baseline in reading speed measured with performance on Reading speed in Diagnostic Reading and Writing Test (DLS; Swedish version). Baseline and at 25 weeks No
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