search
Back to results

Complex Problem Solving Training in Schizophrenic Patients

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Complex Problem Solving Training
Basic Cognitive Training
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Cognitive Training, Complex Problem Solving, Goal Management, Planning

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SRH Klinikum Karlsbad-Langensteinbach

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Complex Problem Solving Training

Basic Cognitive Training

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Functional Capacity as assessed by the Osnabrücker-Arbeitsfähigkeitsprofil summary score
BADS Zoo Map Score (Neuropsychological Test)
Planungstest (Tower of London) Summary Score (Neuropsychological Test)
Plan-A-Day S Solution Time (Neuropsychological Test)

Full Information

First Posted
July 25, 2007
Last Updated
May 14, 2009
Sponsor
Heidelberg University
Collaborators
German Federal Ministry of Education and Research
search

1. Study Identification

Unique Protocol Identification Number
NCT00507988
Brief Title
Complex Problem Solving Training in Schizophrenic Patients
Official Title
Complex Problem Solving Training in Schizophrenic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Heidelberg University
Collaborators
German Federal Ministry of Education and Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Cognitive Training, Complex Problem Solving, Goal Management, Planning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Complex Problem Solving Training
Arm Title
B
Arm Type
Active Comparator
Arm Description
Basic Cognitive Training
Intervention Type
Behavioral
Intervention Name(s)
Complex Problem Solving Training
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Basic Cognitive Training
Intervention Description
10 sessions over 3 weeks of 45 min basic cognitive training (including 45 min computerized training of attention, processing speed, memory)
Primary Outcome Measure Information:
Title
Functional Capacity as assessed by Osnabrücker Arbeitsfähigkeitsprofil "learning ability" subscale
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Functional Capacity as assessed by the Osnabrücker-Arbeitsfähigkeitsprofil summary score
Time Frame
3 weeks
Title
BADS Zoo Map Score (Neuropsychological Test)
Time Frame
3 weeks
Title
Planungstest (Tower of London) Summary Score (Neuropsychological Test)
Time Frame
3 weeks
Title
Plan-A-Day S Solution Time (Neuropsychological Test)
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Weisbrod, MD
Organizational Affiliation
SRH Klinikum Karlsbad-Langensteinbach, Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
SRH Klinikum Karlsbad-Langensteinbach
City
Karlsbad
ZIP/Postal Code
76307
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21527028
Citation
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.
Results Reference
derived

Learn more about this trial

Complex Problem Solving Training in Schizophrenic Patients

We'll reach out to this number within 24 hrs