NCT01055509

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 25, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

June 28, 2013

Status Verified

June 1, 2013

Enrollment Period

2.2 years

First QC Date

January 22, 2010

Last Update Submit

June 27, 2013

Conditions

Schizophrenia

Keywords

Social AdjustmentQuality of lifeRecurrenceHospitalization

Outcome Measures

Primary Outcomes (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.

    Baseline, six month and nine month.

Secondary Outcomes (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.

    Baseline, six month and nine month.

Study Arms (2)

Cognitive Adaptation Training

EXPERIMENTAL

Cognitive adaptation training and treatment as usual

Behavioral: Cognitive Adaptation Training

Treatment as ususal

NO INTERVENTION

Pharmacological treatment, weekly contact to professionals (often in patient's homes), psychoeducation, social skill training in groups and psychosocial intervention with relatives.

Interventions

Cognitive Adaptation TrainingBEHAVIORAL

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.

Also known as: Memory disorders, Adaptation
Cognitive Adaptation Training

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Early Intervention Team

Aabenraa, DK.6200, Denmark

Location

Schizophrenic Clinic, Psychiatric Department in Esbjerg and Ribe

Esbjerg N, DK-6715, Denmark

Location

Early Intervention Team

Odense, Dk-5000, Denmark

Location

Related Publications (8)

  • 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.

    PMID: 16905634BACKGROUND

  • 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.

    PMID: 11354597BACKGROUND

  • 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.

    PMID: 15888434BACKGROUND

  • 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.

    PMID: 10755673BACKGROUND

  • 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.

    PMID: 17255120BACKGROUND

  • 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.

    PMID: 17932089BACKGROUND

  • 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.

    PMID: 12693434BACKGROUND

  • 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.

    PMID: 10910797BACKGROUND

MeSH Terms

Conditions

SchizophreniaSocial AdjustmentRecurrence

Interventions

Acclimatization

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersSocial BehaviorBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adaptation, PhysiologicalPhysiological PhenomenaAdaptation, BiologicalBiological Phenomena

Study Officials

  • Lise Hounsgaard, PhD

    Research Unit of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 22, 2010

First Posted

January 25, 2010

Study Start

January 1, 2009

Primary Completion

April 1, 2011

Study Completion

August 1, 2011

Last Updated

June 28, 2013

Record last verified: 2013-06

Locations

DK(3)