Complex Problem Solving Training in Schizophrenic Patients
May 14, 2009 updated by: Heidelberg University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
91
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Karlsbad, Germany, 76307
- SRH Klinikum Karlsbad-Langensteinbach
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A
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)
|
|
Active Comparator: B
Basic Cognitive Training
|
10 sessions over 3 weeks of 45 min basic cognitive training (including 45 min computerized training of attention, processing speed, memory)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Functional Capacity as assessed by Osnabrücker Arbeitsfähigkeitsprofil "learning ability" subscale
Time Frame: 3 weeks
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Functional Capacity as assessed by the Osnabrücker-Arbeitsfähigkeitsprofil summary score
Time Frame: 3 weeks
|
3 weeks
|
|
BADS Zoo Map Score (Neuropsychological Test)
Time Frame: 3 weeks
|
3 weeks
|
|
Planungstest (Tower of London) Summary Score (Neuropsychological Test)
Time Frame: 3 weeks
|
3 weeks
|
|
Plan-A-Day S Solution Time (Neuropsychological Test)
Time Frame: 3 weeks
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Matthias Weisbrod, MD, SRH Klinikum Karlsbad-Langensteinbach, Department of Psychiatry
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
February 1, 2009
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
July 25, 2007
First Submitted That Met QC Criteria
July 25, 2007
First Posted (Estimate)
July 27, 2007
Study Record Updates
Last Update Posted (Estimate)
May 15, 2009
Last Update Submitted That Met QC Criteria
May 14, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01GW0630
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.