Complex Problem Solving Training in Schizophrenic Patients

Schizophrenia Clinical Trial

Official title:

Complex Problem Solving Training in Schizophrenic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00507988
• Other study ID #: 01GW0630
• Status: Completed
• Phase: N/A
• First received: July 25, 2007
• Last updated: May 14, 2009
• Start date: August 2007
• Est. completion date: February 2009

Study information

• Verified date: May 2009
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Description:

In patients with schizophrenia, cognitive deficits often lead to an impairment in daily life. This observation has led to the development of cognitive training packages aiming a improving these deficits. However, it is far from clear which level of cognitive functioning provides the best target for cognitive interventions. Traditionally, training has aimed a basic cognitive functions like attention and memory. In the present study we aim at a higher-level of function, namely planning and problem-solving skills, which are trained using the software package Plan-A-Day. The primary hypothesis is that complex problem solving training improved functional capacity more than traditional training programs addressing basic cognitive function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Concurrent Axis-I disorder

• Drug abuse during last 2 months

• Neurological or medical conditions potentially affecting cognition

Study Design

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• Complex Problem Solving Training
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)
• Basic Cognitive Training
10 sessions over 3 weeks of 45 min basic cognitive training (including 45 min computerized training of attention, processing speed, memory)

Locations

Country	Name	City	State
Germany	SRH Klinikum Karlsbad-Langensteinbach	Karlsbad

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Capacity as assessed by Osnabrücker Arbeitsfähigkeitsprofil "learning ability" subscale		3 weeks	No
Secondary	Functional Capacity as assessed by the Osnabrücker-Arbeitsfähigkeitsprofil summary score		3 weeks	No
Secondary	BADS Zoo Map Score (Neuropsychological Test)		3 weeks	No
Secondary	Planungstest (Tower of London) Summary Score (Neuropsychological Test)		3 weeks	No
Secondary	Plan-A-Day S Solution Time (Neuropsychological Test)		3 weeks	No