Clinical trial NCT01780116: Effectiveness of Adherence Therapy for Schizophrenia
Official title: An Evaluation of the Effectiveness of Adherence Therapy for Schizophrenia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Schizophrenia
Schizophreniform Disorder
Schizoaffective Disorder
Keywords: schizophrenia
adherence therapy
medication
randomized controlled trial
cost-effectiveness
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Castle Peak Hospital
name: Kwai Chung Hospital
First posted: 2013-01-30
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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.

Primary outcomes:
measure: re-hospitalization rate
timeFrame: 12 months after completion of intervention
Secondary outcomes:
measure: level of medication adherence
timeFrame: 12 months follow-up
measure: mental status
timeFrame: 12 months follow-up
measure: insight into treatment
timeFrame: 12 months follow-up
measure: functioning
timeFrame: 12 months follow-up
Other outcomes:
measure: program attendance and attrition
timeFrame: 12 months follow-up
Locations:
city: Kwai Chung
country: Hong Kong
facility: Kwai Chung Hospital
state: NT
city: Tuen Mun
country: Hong Kong
facility: Castle Peak Hospital
state: NT
Study officials:
affiliation: The Hogn Kong Polytechnic University
name: WT Chien, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 Research, 'The Personal and Political of Mental Health Nursing Research' (5-6 September 2013), Warwick Conference Centre, Coventry, UK. London: Royal College of Nursing.
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.
citation: Chien WT, Mui J, Gray R, Cheung E. Adherence therapy versus routine psychiatric care for people with schizophrenia spectrum disorders: a randomised controlled trial. BMC Psychiatry. 2016 Feb 25;16:42. doi: 10.1186/s12888-016-0744-6.