Effectiveness of Adherence Therapy for Schizophrenia

The Hong Kong Polytechnic University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Schizophreniform Disorder; Schizophrenia; Schizoaffective Disorder

Treatments: Behavioral: Adherence therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01780116

AT-2013

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 134 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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134 participants in 2 patient groups

Medicaiton adherence therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Adherence therapy

Routine community care

No Intervention group

Description:

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