Effectiveness of Adherence Therapy for Schizophrenia

Sponsor

The Hong Kong Polytechnic University (Other)

Overall Status

Completed

CT.gov ID

NCT01780116

Collaborator

Castle Peak Hospital (Other), Kwai Chung Hospital, Hong Kong (Other)

134

Enrollment

Locations

Arms

33.1

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Schizophreniform Disorder Schizoaffective Disorder	Behavioral: Adherence therapy	Phase 1/Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

134 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

May 1, 2013

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Medicaiton adherence therapy 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 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. Other Names: Medication adherence program
No Intervention: Routine community care Routine Community psychiatric nursing services provided by the Community Psychiatric Nurses in the practice field

Arm

Intervention/Treatment

Experimental: Medicaiton adherence therapy

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

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.

Other Names:

Medication adherence program

No Intervention: Routine community care

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

Outcome Measures

Primary Outcome Measures

re-hospitalization rate [12 months after completion of intervention]
rate and length of psychiatric hospital readmission immediately, 6 months and 12 months after the completion of the intervention undertaken

Secondary Outcome Measures

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

Other Outcome Measures

program attendance and attrition [12 months follow-up]
attendance and attrition rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.