NCT02068261

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 23, 2015

Status Verified

October 1, 2015

Enrollment Period

2.9 years

First QC Date

February 19, 2014

Last Update Submit

October 22, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

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

    Baseline and at 25 weeks

Secondary Outcomes (10)

  • Change from baseline in Adult Self Report (ASR; ASEBA) Attention problems scale.

    Baseline and at 25 weeks

  • Change from baseline in Adult Self Report (ASR; ASEBA) Internalizing index.

    Baseline and at 25 weeks

  • Change from baseline in Adult Self Report (ASR; ASEBA) Externalizing index.

    Baseline and at 25 weeks

  • Change from baseline in Adult Self Report (ASR; ASEBA) Adaptive functioning scales.

    Baseline and at 25 weeks

  • Change from baseline in Executive functioning measured with Behavior Rating Inventory of Executive Function-Adult (BRIEF-A).

    Baseline and at 25 weeks

  • +5 more secondary outcomes

Study Arms (2)

Cogmed working memory training

EXPERIMENTAL

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.

Behavioral: Computerized Cogmed working memory training

Treatment as usual

ACTIVE COMPARATOR

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.

Behavioral: Treatment as usual

Interventions

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.

Cogmed working memory training

Treatment as usual can consist of medication, psychotherapy, counseling, and psychological assessment.

Treatment as usual

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric Research Centre

Örebro, Örebro County, 701 16, Sweden

RECRUITING

MeSH Terms

Conditions

Substance-Related DisordersAnxiety DisordersDepressionAntisocial Personality DisorderDyslexia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersBehavioral SymptomsBehaviorPersonality DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental Disorders

Study Officials

  • Lars Kjellin, Docent

    Örebro Läns Landsting

    STUDY DIRECTOR

Central Study Contacts

Rickard Ahlberg, doctoral student

CONTACT

Kurt Skårberg, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical psychologist, doctoral student.

Study Record Dates

First Submitted

February 19, 2014

First Posted

February 21, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

October 23, 2015

Record last verified: 2015-10

Locations