Effectiveness of Adherence Therapy for Schizophrenia

Study Overview
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Brief Summary
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When compared with those in the control (usual care) group, participants in the AT group are expected to demonstrate significant improvements immediately and at three, six and 12 months after completion of the intervention in: level of medication adherence, readmission rate, mental status, insight into treatment, and level of functioning.

Detailed Description
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When compared with those in the control (usual care) group, participants in the AT group are expected to demonstrate significant improvements immediately and at three, six and 12 months after completion of the intervention in the following aspects: level of adherence to antipsychotic medication, rate and length of psychiatric hospital readmission, mental status, insight and attitude into illness and treatment, and level of functioning. The primary outcomes are level of antipsychotic medication adherence, re-hospitalization rates and mental status; and the patients' drug attitude will be the mediating factor of the AT.

Official Title
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An Evaluation of the Effectiveness of Adherence Therapy for Schizophrenia: A Randomized Controlled Trial

Conditions
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Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder

Intervention / Treatment
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* Behavioral: Adherence therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria of the patients include those who: are Hong Kong Chinese residents; have a primary diagnosis of schizophrenia or its subtypes such as schizophreniform and schizoaffective disorders not more than 3 years; have been prescribed oral antipsychotics for at least 1 month; are aged 18-65 years; have Positive and Negative Syndrome Scale (PANSS) score >60 and are judged by the case Community Psychiatric Nurse/psychiatrist as non-adherents; and are able to understand Cantonese/Mandarin. Patients will be excluded if they have: only depot/intramuscular injections as regular psychiatric medication; co-morbidity of learning disability and organic brain disease, or clinically significant medical diseases; participated in adherence therapy; and/or visual, language or communication difficulty.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medicaiton adherence therapy<br>Adherence therapy, consisting of six, 2-hour sessions over 3 months, in three phases: Engaging patients: assessing needs and concerns in medication adherence; Reviewing strengths and barriers and developing coping strategies; and Rationalizing beliefs and concerns and preventing relapse. | Behavioral: Adherence therapy<br>* Systematic and highly structured medication adherence program using the motivational interviewing (MI) technique that focuses on six principles: expressing empathy, developing discrepancy between client's beliefs and evidence, supporting self-efficacy, avoiding argumentation, and rolling with resistance to behavioral change. MI is often able (with in-depth behavioral analysis) to focus on particular consequences of problem behavior, such as medication non-adherence, that have an obvious impact on patients.<br>* Other names: Medication adherence program;|
| No Intervention: Routine community care<br>Routine Community psychiatric nursing services provided by the Community Psychiatric Nurses in the practice field | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| re-hospitalization rate | rate and length of psychiatric hospital readmission immediately, 6 months and 12 months after the completion of the intervention undertaken | 12 months after completion of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of medication adherence | level of adherence to antipsychotic medication measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention | 12 months follow-up | 
| mental status | symptom severity measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention | 12 months follow-up | 
| insight into treatment | insights into illness and treatment measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention | 12 months follow-up | 
| functioning | level of functioning measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention | 12 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, adherence therapy, medication, randomized controlled trial, cost-effectiveness