Effectiveness of Adherence Therapy for Schizophrenia

February 17, 2016 updated by: Chien Wai-Tong, The Hong Kong Polytechnic University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
    • NT
      • Kwai Chung, NT, Hong Kong
        • Kwai Chung Hospital
      • Tuen Mun, NT, Hong Kong
        • Castle Peak Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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 Names:
  • Medication adherence program
No Intervention: Routine community care
Routine Community psychiatric nursing services provided by the Community Psychiatric Nurses in the practice field

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months after completion of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months follow-up
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
12 months follow-up
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
12 months follow-up
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
12 months follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
program attendance and attrition
Time Frame: 12 months follow-up
attendance and attrition rate
12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Collaborators

Castle Peak Hospital
Kwai Chung Hospital, Hong Kong

Investigators

  • Principal Investigator: WT Chien, PhD, The Hogn Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

January 29, 2013

First Submitted That Met QC Criteria

January 29, 2013

First Posted (Estimate)

January 30, 2013

Study Record Updates

Last Update Posted (Estimate)

February 19, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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