Effectiveness of Adherence Therapy for Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-02-29

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.

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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:

1. level of adherence to antipsychotic medication,
2. rate and length of psychiatric hospital readmission,
3. mental status,
4. insight and attitude into illness and treatment, and
5. 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.

Conditions

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Schizophrenia Schizophreniform Disorder Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Medicaiton adherence therapy

Adherence therapy, consisting of six, 2-hour sessions over 3 months, in three phases:

1. Engaging patients: assessing needs and concerns in medication adherence;
2. Reviewing strengths and barriers and developing coping strategies; and
3. Rationalizing beliefs and concerns and preventing relapse.

Group Type EXPERIMENTAL

Adherence therapy

Intervention Type BEHAVIORAL

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.

Routine community care

Routine Community psychiatric nursing services provided by the Community Psychiatric Nurses in the practice field

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Adherence therapy

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Medication adherence program

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No