Effectiveness of Adherence Therapy for Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01780116
• Other study ID #: AT-2013
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 29, 2013
• Last updated: February 17, 2016
• Start date: May 2013
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Health and Medical Research Fund, Food & Health Bureau
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophreniform Disorder

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Kwai Chung Hospital	Kwai Chung	NT
Hong Kong	Castle Peak Hospital	Tuen Mun	NT

Sponsors (3)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Castle Peak Hospital, Kwai Chung Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (3)

Chien WT, Leung SF, Yeung FK, Wong WK. Current approaches to treatments for schizophrenia spectrum disorders, part II: psychosocial interventions and patient-focused perspectives in psychiatric care. Neuropsychiatr Dis Treat. 2013;9:1463-81. doi: 10.2147/NDT.S49263. Epub 2013 Sep 25. Review. — View Citation

Chien WT, Mui JH, Cheung EF, Gray R. Effects of motivational interviewing-based adherence therapy for schizophrenia spectrum disorders: a randomized controlled trial. Trials. 2015 Jun 14;16:270. doi: 10.1186/s13063-015-0785-z. — View Citation

Chien, W.T., Mui, J., Cheung, E., & Gray, R. (2013). Effectiveness of medication adherence therapy for schizophrenia: A randomized controlled trial. Presentation (Book of Abstracts, pp. 144-146) at the 19th International Network for Psychiatric Nursing Re

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	program attendance and attrition	attendance and attrition rate	12 months follow-up	No
Primary	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	No
Secondary	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	No
Secondary	mental status	symptom severity measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention	12 months follow-up	No
Secondary	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	No
Secondary	functioning	level of functioning measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention	12 months follow-up	No