Compensatory Strategies Applied to Cognitive Impairment in Schizophrenia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: Cognitive Adaptation Training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Adaptation Training<br>Cognitive adaptation training and treatment as usual | Behavioral: Cognitive Adaptation Training<br>* 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.<br>* Other names: Adaptation;|
| No Intervention: Treatment as ususal<br>Pharmacological treatment, weekly contact to professionals (often in patient's homes), psychoeducation, social skill training in groups and psychosocial intervention with relatives. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | Baseline, six month and nine month. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social Adjustment, Quality of life, Recurrence, Hospitalization