Compensatory Strategies Applied to Cognitive Impairment in Schizophrenia

NCT ID: NCT01055509

Last Updated: 2013-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-08-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive Adaptation Training

Cognitive adaptation training and treatment as usual

Group Type: EXPERIMENTAL

Cognitive Adaptation Training

Intervention Type: BEHAVIORAL

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.

Treatment as ususal

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive Adaptation Training

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Memory disorders; Adaptation

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern Denmark

OTHER

Sponsor Role: lead

Responsible Party

Birte Oestergaard

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lise Hounsgaard, PhD

Role: PRINCIPAL_INVESTIGATOR

Research Unit of Nursing

Locations

Early Intervention Team

Aabenraa, , Denmark

Schizophrenic Clinic, Psychiatric Department in Esbjerg and Ribe

Esbjerg N, , Denmark

Early Intervention Team

Odense, , Denmark

Countries

Denmark

References

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.

Reference Type: BACKGROUND

PMID: 16905634 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11354597 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15888434 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10755673 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17255120 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17932089 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12693434 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10910797 (View on PubMed)

Other Identifiers

UNR-2008037-1

Identifier Type: -

Identifier Source: org_study_id