NCT01302314

Brief Summary

This study will examine the effects of a theoretically grounded and manualized cognitive rehabilitation program on patients with Spina Bifida (SB). SB is often associated with deficit in higher order control over cognition, emotion and behaviour; which is typically referred to as executive functions. The present study will examine the efficacy of Goal Management Training (GMT) in patients with SB that experience executive difficulties. It is expected that GMT will have a favourable effect on cognitive executive functioning, psychological and health related factors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

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

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

2 months

First QC Date

February 23, 2011

Last Update Submit

January 21, 2014

Conditions

Executive DysfunctionCognitive DeficitsSpina Bifida

Outcome Measures

Primary Outcomes (6)

  • Self and informant report of cognitive difficulties

    Behavior Rating Inventory for Executive Functions (BRIEF-A; Gioia et al., 2000).

    Baseline, 3 months and 6 months

  • Self and informant report of cognitive difficulties

    The Dysexecutive Questionnaire (DEX; Burgess, Alderman, Emslie, Evans \& Wilson, 1996).

    Baseline, 3 months, and 6 months

  • self report of cognitive failures

    Cognitive Failures Questionnaire (Broadbent, Cooper, FitzGerald, \& Parkes, 1982).

    baseline, 3 months, and 6 months

  • self report of psychological problems

    Symptom Checklist 25 (SCL-25; Derogatis, 1994).

    baseline, 3 months, and 6 months

  • self report of quality of life

    SF36 (Ware \& Sherbourne, 1992).

    baseline, 3 months, and 6 months

  • Self report of coping strategies

    General Coping Questionnaire (GCQ-30; Joseph, Williams \& Yule, 1992a).

    baseline, 3 months, and 6 months

Secondary Outcomes (5)

  • Cognitive functions measured by neuropsychological tests

    Baseline, 3 months and 6 months

  • Cognitive functions measured by neuropsychological tests

    baseline, 3 months and 6 months

  • Cognitive functions measured by neuropsychological tests

    baseline, 3 months, and 6 months

  • Cognitive functions measured by neuropsychological tests

    baseline, 3 months and 6 months

  • Cognitive functions measured by neuropsychological tests

    baseline, 3 months and 6 months

Study Arms (1)

cognitive rehabilitation

EXPERIMENTAL
Behavioral: Goal management training (GMT)

Interventions

Goal management training (GMT)BEHAVIORAL

Fourteen hours of GMT during a time period of three months.

cognitive rehabilitation

Eligibility Criteria

Age20 Years - 46 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Spina bifida with myelomeningocele (MMC)
  • Between 20 and 46 years of age
  • Problems in the domain of executive functioning

You may not qualify if:

  • Major psychiatric disorder
  • Reported alcohol or substance abuse within the past year
  • Aphasia or other specified language problems causing potential validity problems
  • IQ \< 70

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnaas rehabilitation hospital

Oslo, Nesoddtangen, 1450, Norway

Location

MeSH Terms

Conditions

Cognition DisordersSpinal Dysraphism

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental DisordersNeural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jan Stubberud, Psychologist

    Sunnaas Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Neuropsychologist and PhD student

Study Record Dates

First Submitted

February 23, 2011

First Posted

February 24, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2011

Study Completion

December 1, 2011

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations

NO(1)