SchizophreniaNCT00507988
Complex Problem Solving Training in Schizophrenic Patients
A study testing Complex Problem Solving Training and Basic Cognitive Training in people with Schizophrenia and Schizoaffective Disorder, run by Heidelberg University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Complex Problem Solving Training and Basic Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2007to Feb 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Concurrent Axis-I disorder
- Drug abuse during last 2 months
- Neurological or medical conditions potentially affecting cognition
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Complex Problem Solving Training, Basic Cognitive Training
- Keywords
- Cognitive Training, Complex Problem Solving, Goal Management, Planning
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex Problem Solving TrainingBehavioural
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 TrainingBehavioural
10 sessions over 3 weeks of 45 min basic cognitive training (including 45 min computerized training of attention, processing speed, memory)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Complex Problem Solving Training Receives: Behavioral: Complex Problem Solving Training |
| B | Active comparator | Basic Cognitive Training Receives: Behavioral: Basic Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity as assessed by Osnabrücker Arbeitsfähigkeitsprofil "learning ability" subscale
Measured: 3 weeks
Secondary outcomes (4)
Functional Capacity as assessed by the Osnabrücker-Arbeitsfähigkeitsprofil summary score
Measured: 3 weeks
BADS Zoo Map Score (Neuropsychological Test)
Measured: 3 weeks
Planungstest (Tower of London) Summary Score (Neuropsychological Test)
Measured: 3 weeks
Plan-A-Day S Solution Time (Neuropsychological Test)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2007 (estimated)
- Study startAug 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Investigators
- Matthias Weisbrod, MD, Principal investigator, SRH Klinikum Karlsbad-Langensteinbach, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507988
- Sponsor's protocol ID
- 01GW0630
- Status last verified
- May 2009
- First submitted
- 25 Jul 2007
- Last updated
- 15 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21527028
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Problem Solving Training in Schizophrenic Patients
- ClinicalTrials.gov ID
- NCT00507988
- Acronym / sponsor ID
- 01GW0630
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Cognitive Training, Complex Problem Solving, Goal Management, Planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Aug 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 27 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Complex Problem Solving TrainingComplex Problem Solving Training |
| B | Active comparator | Behavioral: Basic Cognitive TrainingBasic Cognitive Training |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Concurrent Axis-I disorder
- Drug abuse during last 2 months
- Neurological or medical conditions potentially affecting cognition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complex Problem Solving Training10 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) | Behavioural | A |
| Basic Cognitive Training10 sessions over 3 weeks of 45 min basic cognitive training (including 45 min computerized training of attention, processing speed, memory) | Behavioural | B |
Primary outcome
Functional Capacity as assessed by Osnabrücker Arbeitsfähigkeitsprofil "learning ability" subscale
Time frame: 3 weeks
4 secondary outcomes
Functional Capacity as assessed by the Osnabrücker-Arbeitsfähigkeitsprofil summary score
Time frame: 3 weeks
BADS Zoo Map Score (Neuropsychological Test)
Time frame: 3 weeks
Planungstest (Tower of London) Summary Score (Neuropsychological Test)
Time frame: 3 weeks
Plan-A-Day S Solution Time (Neuropsychological Test)
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2009.
- Derived from this study: PubMed 21527028Rodewald 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Weisbrod, MD principal investigator
SRH Klinikum Karlsbad-Langensteinbach, Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex Problem Solving Training and Basic Cognitive Training in people with Schizophrenia and Schizoaffective Disorder, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Capacity as assessed by Osnabrücker Arbeitsfähigkeitsprofil "learning ability" subscale (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00507988, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2009.