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Effectiveness of Adherence Therapy for Schizophrenia

Primary Purpose

Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder

Status
Completed
Phase
Phase 1
Locations
Hong Kong
Study Type
Interventional
Intervention
Adherence therapy
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Schizophrenia focused on measuring schizophrenia, adherence therapy, medication, randomized controlled trial, cost-effectiveness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Kwai Chung Hospital
  • Castle Peak Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Medicaiton adherence therapy

Routine community care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
January 29, 2013
Last Updated
February 17, 2016
Sponsor
The Hong Kong Polytechnic University
Collaborators
Castle Peak Hospital, Kwai Chung Hospital, Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01780116
Brief Title
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

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Castle Peak Hospital, Kwai Chung Hospital, Hong Kong

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder
Keywords
schizophrenia, adherence therapy, medication, randomized controlled trial, cost-effectiveness

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medicaiton adherence therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine community care
Arm Type
No Intervention
Arm Description
Routine Community psychiatric nursing services provided by the Community Psychiatric Nurses in the practice field
Intervention Type
Behavioral
Intervention Name(s)
Adherence therapy
Other Intervention Name(s)
Medication adherence program
Intervention Description
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.
Primary Outcome Measure Information:
Title
re-hospitalization rate
Description
rate and length of psychiatric hospital readmission immediately, 6 months and 12 months after the completion of the intervention undertaken
Time Frame
12 months after completion of intervention
Secondary Outcome Measure Information:
Title
level of medication adherence
Description
level of adherence to antipsychotic medication measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention
Time Frame
12 months follow-up
Title
mental status
Description
symptom severity measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention
Time Frame
12 months follow-up
Title
insight into treatment
Description
insights into illness and treatment measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention
Time Frame
12 months follow-up
Title
functioning
Description
level of functioning measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention
Time Frame
12 months follow-up
Other Pre-specified Outcome Measures:
Title
program attendance and attrition
Description
attendance and attrition rate
Time Frame
12 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WT Chien, PhD
Organizational Affiliation
The Hogn Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kwai Chung Hospital
City
Kwai Chung
State/Province
NT
Country
Hong Kong
Facility Name
Castle Peak Hospital
City
Tuen Mun
State/Province
NT
Country
Hong Kong

12. IPD Sharing Statement

Citations:
PubMed Identifier
24109184
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.
Results Reference
background
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.
Results Reference
result
PubMed Identifier
26072311
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.
Results Reference
result
PubMed Identifier
26911397
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.
Results Reference
derived

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Effectiveness of Adherence Therapy for Schizophrenia

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