NCT00507988

Brief Summary

The primary purpose of the study is to assess whether a planning and problem-solving training is more effective in improving work therapy performance in patients with schizophrenia than traditional training programs addressing basic cognitive functions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Aug 2007

Shorter than P25 for not_applicable schizophrenia

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2007

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

May 15, 2009

Status Verified

May 1, 2009

Enrollment Period

1.5 years

First QC Date

July 25, 2007

Last Update Submit

May 14, 2009

Conditions

Keywords

Cognitive TrainingComplex Problem SolvingGoal ManagementPlanning

Outcome Measures

Primary Outcomes (1)

  • Functional Capacity as assessed by Osnabrücker Arbeitsfähigkeitsprofil "learning ability" subscale

    3 weeks

Secondary Outcomes (4)

  • Functional Capacity as assessed by the Osnabrücker-Arbeitsfähigkeitsprofil summary score

    3 weeks

  • BADS Zoo Map Score (Neuropsychological Test)

    3 weeks

  • Planungstest (Tower of London) Summary Score (Neuropsychological Test)

    3 weeks

  • Plan-A-Day S Solution Time (Neuropsychological Test)

    3 weeks

Study Arms (2)

A

EXPERIMENTAL

Complex Problem Solving Training

Behavioral: Complex Problem Solving Training

B

ACTIVE COMPARATOR

Basic Cognitive Training

Behavioral: Basic Cognitive Training

Interventions

10 sessions of 45 minutes complex problem solving training over 3 weeks (including 30 minutes of computerized planning and problem-solving training with Plan-A-Day and 15 minutes group session for transfer to everyday situations)

A

10 sessions over 3 weeks of 45 min basic cognitive training (including 45 min computerized training of attention, processing speed, memory)

B

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with schizophrenic or schizoaffective Disorder (DSM IV)
  • Remitted positive symptoms (PANSS positive all ≤ 4), clinical stability
  • Native German speaker
  • Verbal IQ \> 80
  • Visual acuity normal or corrected to normal

You may not qualify if:

  • Concurrent Axis-I disorder
  • Drug abuse during last 2 months
  • Neurological or medical conditions potentially affecting cognition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SRH Klinikum Karlsbad-Langensteinbach

Karlsbad, 76307, Germany

Location

Related Publications (1)

  • Rodewald K, Rentrop M, Holt DV, Roesch-Ely D, Backenstrass M, Funke J, Weisbrod M, Kaiser S. Planning and problem-solving training for patients with schizophrenia: a randomized controlled trial. BMC Psychiatry. 2011 Apr 28;11:73. doi: 10.1186/1471-244X-11-73.

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Matthias Weisbrod, MD

    SRH Klinikum Karlsbad-Langensteinbach, Department of Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 25, 2007

First Posted

July 27, 2007

Study Start

August 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

May 15, 2009

Record last verified: 2009-05

Locations