search
Back to results

Compensatory Strategies Applied to Cognitive Impairment in Schizophrenia (CAT-Denmark)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cognitive Adaptation Training
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Social Adjustment, Quality of life, Recurrence, Hospitalization

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Early Intervention Team
  • Schizophrenic Clinic, Psychiatric Department in Esbjerg and Ribe
  • Early Intervention Team

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive Adaptation Training

Treatment as ususal

Arm Description

Cognitive adaptation training and treatment as usual

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 22, 2010
Last Updated
June 27, 2013
Sponsor
University of Southern Denmark
search

1. Study Identification

Unique Protocol Identification Number
NCT01055509
Brief Title
Compensatory Strategies Applied to Cognitive Impairment in Schizophrenia
Acronym
CAT-Denmark
Official Title
Effectiveness of Cognitive Adaptation Training Applied to Cognitive Impairment in Schizophrenia - A Randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Social Adjustment, Quality of life, Recurrence, Hospitalization

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Cognitive Adaptation Training
Arm Type
Experimental
Arm Description
Cognitive adaptation training and treatment as usual
Arm Title
Treatment as ususal
Arm Type
No Intervention
Arm Description
Pharmacological treatment, weekly contact to professionals (often in patient's homes), psychoeducation, social skill training in groups and psychosocial intervention with relatives.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Adaptation Training
Other Intervention Name(s)
Memory disorders, Adaptation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Social functioning assessed by Global Assessment of Function test and Health of the Nation Outcome Scales item 9-12 concerning social problems.
Description
The effect of intervention on primary outcome are invetigated as longitudinal data at six and nine month. The data are analysed using mixed models.
Time Frame
Baseline, six month and nine month.
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Baseline, six month and nine month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lise Hounsgaard, PhD
Organizational Affiliation
Research Unit of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Early Intervention Team
City
Aabenraa
ZIP/Postal Code
DK.6200
Country
Denmark
Facility Name
Schizophrenic Clinic, Psychiatric Department in Esbjerg and Ribe
City
Esbjerg N
ZIP/Postal Code
DK-6715
Country
Denmark
Facility Name
Early Intervention Team
City
Odense
ZIP/Postal Code
Dk-5000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
16905634
Citation
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.
Results Reference
background
PubMed Identifier
11354597
Citation
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.
Results Reference
background
PubMed Identifier
15888434
Citation
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.
Results Reference
background
PubMed Identifier
10755673
Citation
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.
Results Reference
background
PubMed Identifier
17255120
Citation
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.
Results Reference
background
PubMed Identifier
17932089
Citation
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.
Results Reference
background
PubMed Identifier
12693434
Citation
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.
Results Reference
background
PubMed Identifier
10910797
Citation
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.
Results Reference
background

Learn more about this trial

Compensatory Strategies Applied to Cognitive Impairment in Schizophrenia

We'll reach out to this number within 24 hrs