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Effectiveness of Adherence Therapy for Schizophrenia

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01780116
Enrollment
134
Registered
2013-01-30
Start date
2013-05-31
Completion date
2016-02-29
Last updated
2016-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizoaffective Disorder, Schizophrenia, Schizophreniform Disorder

Keywords

schizophrenia, adherence therapy, medication, randomized controlled trial, cost-effectiveness

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.

Detailed 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.

Interventions

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.

Sponsors

Castle Peak Hospital
CollaboratorOTHER_GOV
Kwai Chung Hospital
CollaboratorOTHER
The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
re-hospitalization rate12 months after completion of interventionrate and length of psychiatric hospital readmission immediately, 6 months and 12 months after the completion of the intervention undertaken

Secondary

MeasureTime frameDescription
level of medication adherence12 months follow-uplevel of adherence to antipsychotic medication measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention
mental status12 months follow-upsymptom severity measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention
insight into treatment12 months follow-upinsights into illness and treatment measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention
functioning12 months follow-uplevel of functioning measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention

Other

MeasureTime frameDescription
program attendance and attrition12 months follow-upattendance and attrition rate

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026