Effectiveness of Adherence Therapy for Schizophrenia - Full Text View

Purpose

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.

Condition	Intervention	Phase
Schizophrenia Schizophreniform Disorder Schizoaffective Disorder	Behavioral: Adherence therapy	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research
Official Title:	An Evaluation of the Effectiveness of Adherence Therapy for Schizophrenia: A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Further study details as provided by The Hong Kong Polytechnic University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Other Outcome Measures:

program attendance and attrition [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
attendance and attrition rate

Estimated Enrollment:	134
Study Start Date:	April 2013
Estimated Study Completion Date:	April 2015
Estimated Primary Completion Date:	March 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Medicaiton adherence therapy 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.	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
No Intervention: Routine community care Routine Community psychiatric nursing services provided by the Community Psychiatric Nurses in the practice field

Arms

Assigned Interventions

Experimental: Medicaiton adherence therapy

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.

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

No Intervention: Routine community care

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780116

Contacts

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

Locations

Hong Kong
Kwai Chung Hospital	Not yet recruiting
Kwai Chung, NT, Hong Kong
Contact: WT Chien, PhD 852-2766 5648 wai.tong.chien@polyu.edu.hk
Contact: Glendy Ip, MSc 852-2959 8463 ipsh@ha.org.hk
Sub-Investigator: Glendy Ip, MSc
Castle Peak Hospital	Not yet recruiting
Tuen Mun, NT, Hong Kong
Contact: Jolene Mui, MSc 852-24568487 muihc@ha.org.hk
Contact: Alan Chan, BSc 852-6594 3964 rsalanc@polyu.edu.hk
Sub-Investigator: Eric Cheung, MD
Sub-Investigator: Jolene Mui, MSc

Sponsors and Collaborators

The Hong Kong Polytechnic University

Castle Peak Hospital, Hong Kong

Kwai Chung Hospital, Hong Kong

Investigators

Principal Investigator:

WT Chien, PhD

The Hogn Kong Polytechnic University

More Information

No publications provided

Responsible Party:	Chien Wai-Tong, Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:	NCT01780116 History of Changes
Other Study ID Numbers:	AT-2013
Study First Received:	January 29, 2013
Last Updated:	January 29, 2013
Health Authority:	Hong Kong: Health and Medical Research Fund, Food & Health Bureau

Keywords provided by The Hong Kong Polytechnic University:

schizophrenia
adherence therapy
medication
randomized controlled trial
cost-effectiveness

Additional relevant MeSH terms:

Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013