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SchizophreniaCAT-DenmarkNCT01055509

Compensatory Strategies Applied to Cognitive Impairment in Schizophrenia

A study testing Cognitive Adaptation Training in people with Schizophrenia, run by University of Southern Denmark at 3 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether Cognitive Adaptation Training are effective in comparison with conventional treatment, focusing on social functions, symptoms, relapse, re-hospitalisation, and quality of life in outpatients with schizophrenia. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Schizophrenia
What is being tested?
Cognitive Adaptation Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
3 sitesDenmark
Study dates
Jan 2009to Aug 2011
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of schizophrenia.
  • More than one year from referral to the psychiatric clinic.
  • Receive mental medication and continual psychosocial treatment.
  • Participants who have signed informed consent.

Who cannot join

  • Participants who don't understand or speak Danish.
  • Participants who live at an institution or who are long-term hospitalized.
  • Participants who are unwillingly to complete protocol.

Trial locations and contacts

3 sites in 1 country.

Denmark3 sites

  • Early Intervention Team

    Aabenraa, DK.6200

  • Schizophrenic Clinic, Psychiatric Department in Esbjerg and Ribe

    Esbjerg N, DK-6715

  • Early Intervention Team

    Odense, Dk-5000

Other trials in Denmark

About this study

Official title: Effectiveness of Cognitive Adaptation Training Applied to Cognitive Impairment in Schizophrenia - A Randomised Trial

The purpose of this study is to determine whether Cognitive Adaptation Training are effective in comparison with conventional treatment, focusing on social functions, symptoms, relapse, re-hospitalisation, and quality of life in outpatients with schizophrenia.

Read the detailed description

It is estimated that approximately 80% of patients with schizophrenia have reduced cognitive functions, representing problems with attention, verbal memory, short-term memory and executive functions (1-3). These impairments might have an impact on the patients ability to complete rehabilitation programmes, apply learned strategies to social problems, develop work skills and manage daily life (4,5). The effect of Cognitive Adaptation Training has been tested as a psychosocial treatment including training of compensatory strategies in order to sequence patient's adaptive behaviour, showing promising results concerning improved social functions (6). There are however no solid evidence for these statements. The existing few studies investigating the effect of Cognitive Adaptation Training (6-8) are underpowered (small sample sizes) and have a lack of younger patients, which limits the conclusions that can be drawn from the results of the improvement. The present trial employs a prospective design of 26 weeks with a follow-up period of 9 months after inclusion. The study will enroll 164 consecutively recruited participants from three Danish out-patient teams for young adults with a first episode of psychosis.

Conditions
Schizophrenia
Being tested
Cognitive Adaptation Training
Keywords
Social Adjustment, Quality of life, Recurrence, Hospitalization
Medical subject headings
Schizophrenia, Social Adjustment, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Adaptation TrainingBehavioural

    Also called Memory disorders, Adaptation

    All patients receive treatment as usual. Additionally, patients in the intervention arm receives training concerning solving concrete problems related to the patient's daily life using tools such as schedules, schemes and signs. Additional the patient can receive SMS messages or instructions for the use of schedules in cell-phones to prompt for activities. The intervention is conducted in the patients homes every 14th day in a period of six months.

Study groups in NCT01055509
Study groupRoleWhat they receive
Cognitive Adaptation TrainingExperimentalCognitive adaptation training and treatment as usual
Receives: Behavioral: Cognitive Adaptation Training
Treatment as ususalNo interventionPharmacological treatment, weekly contact to professionals (often in patient's homes), psychoeducation, social skill training in groups and psychosocial intervention with relatives.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Social functioning assessed by Global Assessment of Function test and Health of the Nation Outcome Scales item 9-12 concerning social problems.

    The effect of intervention on primary outcome are invetigated as longitudinal data at six and nine month. The data are analysed using mixed models.

    Measured: Baseline, six month and nine month.

Secondary outcomes (1)

  1. Changes in Social Functioning using Camberwell Assessment of Need questionnaire. Symptoms using Positive and Negative Syndrome Scale. Quality of Life using Lehman Quality of Life Interview-brief version. Relapse and frequency of hospitalization.

    The effect of intervention on secondary outcome are invetigated as longitudinal data at six and nine month. The data are analysed using mixed models. However, relapse are analysed using survival analysis.

    Measured: Baseline, six month and nine month.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2010 (estimated)
  2. Study startJan 2009
  3. Primary completionApr 2011
  4. Study completionAug 2011

Resources

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
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01055509
Sponsor's protocol ID
UNR-2008037-1
Acronym
CAT-Denmark
Status last verified
Jun 2013
First submitted
22 Jan 2010
Last updated
28 Jun 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Pfammatter M, Junghan UM, Brenner HD. Efficacy of psychological therapy in schizophrenia: conclusions from meta-analyses. Schizophr Bull. 2006 Oct;32 Suppl 1(Suppl 1):S64-80. doi: 10.1093/schbul/sbl030. Epub 2006 Aug 11.

    PubMed 16905634

  • Johnson-Selfridge M, Zalewski C. Moderator variables of executive functioning in schizophrenia: meta-analytic findings. Schizophr Bull. 2001;27(2):305-16. doi: 10.1093/oxfordjournals.schbul.a006876.

    PubMed 11354597

  • Kurtz MM, Moberg PJ, Ragland JD, Gur RC, Gur RE. Symptoms versus neurocognitive test performance as predictors of psychosocial status in schizophrenia: a 1- and 4-year prospective study. Schizophr Bull. 2005 Jan;31(1):167-74. doi: 10.1093/schbul/sbi004. Epub 2005 Feb 16.

    PubMed 15888434

  • Green MF, Kern RS, Braff DL, Mintz J. Neurocognitive deficits and functional outcome in schizophrenia: are we measuring the "right stuff"? Schizophr Bull. 2000;26(1):119-36. doi: 10.1093/oxfordjournals.schbul.a033430.

    PubMed 10755673

  • Brekke JS, Hoe M, Long J, Green MF. How neurocognition and social cognition influence functional change during community-based psychosocial rehabilitation for individuals with schizophrenia. Schizophr Bull. 2007 Sep;33(5):1247-56. doi: 10.1093/schbul/sbl072. Epub 2007 Jan 25.

    PubMed 17255120

  • Velligan DI, Diamond PM, Mintz J, Maples N, Li X, Zeber J, Ereshefsky L, Lam YW, Castillo D, Miller AL. The use of individually tailored environmental supports to improve medication adherence and outcomes in schizophrenia. Schizophr Bull. 2008 May;34(3):483-93. doi: 10.1093/schbul/sbm111. Epub 2007 Oct 10.

    PubMed 17932089

  • Velligan DI, Prihoda TJ, Ritch JL, Maples N, Bow-Thomas CC, Dassori A. A randomized single-blind pilot study of compensatory strategies in schizophrenia outpatients. Schizophr Bull. 2002;28(2):283-92. doi: 10.1093/oxfordjournals.schbul.a006938.

    PubMed 12693434

  • Velligan DI, Bow-Thomas CC, Huntzinger C, Ritch J, Ledbetter N, Prihoda TJ, Miller AL. Randomized controlled trial of the use of compensatory strategies to enhance adaptive functioning in outpatients with schizophrenia. Am J Psychiatry. 2000 Aug;157(8):1317-23. doi: 10.1176/appi.ajp.157.8.1317.

    PubMed 10910797

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Adaptation Training in people with Schizophrenia, run by University of Southern Denmark at 3 sites in Denmark.

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 4 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 28 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Denmark. 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?

Changes in Social functioning assessed by Global Assessment of Function test and Health of the Nation Outcome Scales item 9-12 concerning social problems. (time frame: Baseline, six month and nine month.). 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 NCT01055509, which also lists 8 linked publications.

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 28 Jun 2013.

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