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Completed

NCT Number: NCT01780116

Effectiveness of Adherence Therapy for Schizophrenia

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Kwai Chung Hospital, Kwai Chung, NT, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adherence Therapy

Behavioral

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 names: Medication adherence program

Primary outcomes

  1. re-hospitalization rate

    Time frame: 12 months after completion of intervention

    rate and length of psychiatric hospital readmission immediately, 6 months and 12 months after the completion of the intervention undertaken

Secondary outcomes

  1. level of medication adherence

    Time frame: 12 months follow-up

    level of adherence to antipsychotic medication measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention

  2. mental status

    Time frame: 12 months follow-up

    symptom severity measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention

  3. insight into treatment

    Time frame: 12 months follow-up

    insights into illness and treatment measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention

  4. functioning

    Time frame: 12 months follow-up

    level of functioning measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention

Other outcomes

  1. program attendance and attrition

    Time frame: 12 months follow-up

    attendance and attrition rate

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Castle Peak Hospital
  • Kwai Chung Hospital

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jan 30, 2013
Registry last updated
Feb 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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