Effectiveness of Adherence Therapy for Schizophrenia

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by The Hong Kong Polytechnic University
Sponsor:
Collaborators:
Castle Peak Hospital, Hong Kong
Kwai Chung Hospital, Hong Kong
Information provided by (Responsible Party):
Chien Wai-Tong, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT01780116
First received: January 29, 2013
Last updated: July 6, 2014
Last verified: July 2014

January 29, 2013
July 6, 2014
May 2013
February 2015   (final data collection date for primary outcome measure)
re-hospitalization rate [ Time Frame: 12 months after completion of intervention ] [ Designated as safety issue: No ]
rate and length of psychiatric hospital readmission immediately, 6 months and 12 months after the completion of the intervention undertaken
Same as current
Complete list of historical versions of study NCT01780116 on ClinicalTrials.gov Archive Site
  • level of medication adherence [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
    level of adherence to antipsychotic medication measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention
  • mental status [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
    symptom severity measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention
  • insight into treatment [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
    insights into illness and treatment measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention
  • functioning [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
    level of functioning measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention
Same as current
program attendance and attrition [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
attendance and attrition rate
Same as current
 
Effectiveness of Adherence Therapy for Schizophrenia
An Evaluation of the Effectiveness of Adherence Therapy for Schizophrenia: A Randomized Controlled Trial

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
  • Schizophrenia
  • Schizophreniform Disorder
  • Schizoaffective Disorder
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 Name: Medication adherence program
  • Experimental: Medicaiton adherence therapy

    Adherence therapy, consisting of six, 2-hour sessions over 3 months, in three phases:

    1. Engaging patients: assessing needs and concerns in medication adherence;
    2. Reviewing strengths and barriers and developing coping strategies; and
    3. Rationalizing beliefs and concerns and preventing relapse.
    Intervention: Behavioral: Adherence therapy
  • No Intervention: Routine community care
    Routine Community psychiatric nursing services provided by the Community Psychiatric Nurses in the practice field
1. 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
134
May 2015
February 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Wai Tong Chien, PhD 852-2766 5648 wai.tong.chien@polyu.edu.hk
Contact: Jolene Mui, MSc 852-2456 8487 muihc@ha.org.hk
Hong Kong
 
NCT01780116
AT-2013
Yes
Chien Wai-Tong, The Hong Kong Polytechnic University
The Hong Kong Polytechnic University
  • Castle Peak Hospital, Hong Kong
  • Kwai Chung Hospital, Hong Kong
Principal Investigator: WT Chien, PhD The Hogn Kong Polytechnic University
The Hong Kong Polytechnic University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP