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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Adaptation Training | Experimental | Cognitive adaptation training and treatment as usual |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Adaptation Training | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lise Hounsgaard, PhD | Research Unit of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Early Intervention Team | Aabenraa | DK.6200 | Denmark | |||
| Schizophrenic Clinic, Psychiatric Department in Esbjerg and Ribe |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16905634 | Background | 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. | |
| 11354597 | Background | 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. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D012917 | Social Adjustment |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000064 | Acclimatization |
| ID | Term |
|---|---|
| D000222 | Adaptation, Physiological |
| D010829 | Physiological Phenomena |
| D000220 | Adaptation, Biological |
| D001686 | Biological Phenomena |
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|
|
| Baseline, six month and nine month. |
| Esbjerg N |
| DK-6715 |
| Denmark |
| Early Intervention Team | Odense | Dk-5000 | Denmark |
| 15888434 | Background | 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. |
| 10755673 | Background | 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. |
| 17255120 | Background | 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. |
| 17932089 | Background | 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. |
| 12693434 | Background | 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. |
| 10910797 | Background | 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. |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |