Effectiveness of Adherence Therapy for Schizophrenia

NCT01780116 | Completed Phase 1 DMC

• 1 other identifier: AT-2013
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 2

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.

Conditions

Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder

Keywords

schizophrenia; adherence therapy; medication; randomized controlled trial; cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• re-hospitalization rate

  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 Outcomes (4)

• level of medication adherence

  12 months follow-up

• mental status

  12 months follow-up

• insight into treatment

  12 months follow-up

• functioning

  12 months follow-up

Other Outcomes (1)

• program attendance and attrition

  12 months follow-up

Study Arms (2)

Medicaiton adherence therapy

EXPERIMENTAL

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

Routine community care

NO INTERVENTION

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

Interventions

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.

Also known as: Medication adherence program

Medicaiton adherence therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Castle Peak Hospital: collaborator
• Kwai Chung Hospital: collaborator

Study Sites (2)

Kwai Chung Hospital

Kwai Chung, NT, Hong Kong

Location

Castle Peak Hospital

Tuenmen, NT, Hong Kong

Location

Related Publications (4)

• 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.

  PMID: 24109184 BACKGROUND

• 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.

  RESULT

• 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.

  PMID: 26072311 RESULT

• 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.

  PMID: 26911397 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• WT Chien, PhD

  The Hogn Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2013
• First Posted: January 30, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: February 1, 2016
• Last Updated: February 19, 2016

Record last verified: 2016-02

Locations

HK (2)