SchizophreniaPhase 1/2NCT01780116
Effectiveness of Adherence Therapy for Schizophrenia
A Phase 1/2 study testing Adherence therapy in people with Schizophrenia and Schizophreniform Disorder, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder
- What is being tested?
- Adherence therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 2 sitesHong Kong
- Study dates
- May 2013to Feb 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Kwai Chung Hospital
Kwai Chung, NT
Castle Peak Hospital
Tuenmen, NT
About this study
Official title: 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.
Read the 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.
- Being tested
- Adherence therapy
- Keywords
- schizophrenia, adherence therapy, medication, randomized controlled trial, cost-effectiveness
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence therapyBehavioural
Also called Medication adherence program
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Adherence therapy |
| Routine community care | No intervention | Routine Community psychiatric nursing services provided by the Community Psychiatric Nurses in the practice field |
What is being measured
The primary outcome is the main question the study is designed to answer.
re-hospitalization rate
rate and length of psychiatric hospital readmission immediately, 6 months and 12 months after the completion of the intervention undertaken
Measured: 12 months after completion of intervention
Secondary outcomes (4)
level of medication adherence
level of adherence to antipsychotic medication measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention
Measured: 12 months follow-up
mental status
symptom severity measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention
Measured: 12 months follow-up
insight into treatment
insights into illness and treatment measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention
Measured: 12 months follow-up
functioning
level of functioning measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention
Measured: 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Castle Peak Hospital, Kwai Chung Hospital
- Responsible party
- Principal investigator, Chien Wai-Tong, The Hong Kong Polytechnic University
- Investigators
- WT Chien, PhD, Principal investigator, The Hogn Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780116
- Sponsor's protocol ID
- AT-2013
- Status last verified
- Feb 2016
- First submitted
- 29 Jan 2013
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24109184Chien, 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.
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.
PubMed 26072311Chien 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.
PubMed 26911397
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Effectiveness of Adherence Therapy for Schizophrenia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01780116
- Acronym / sponsor ID
- AT-2013
- Keywords
- schizophrenia, adherence therapy, medication, randomized controlled trial, cost-effectiveness
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Castle Peak Hospital, Kwai Chung Hospital
- Study start
- May 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 30 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medicaiton adherence therapy | Experimental | Behavioral: Adherence therapyAdherence 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. |
| Routine community care | No intervention | –Routine Community psychiatric nursing services provided by the Community Psychiatric Nurses in the practice field |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adherence therapyAlso: Medication adherence programSystematic 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. | Behavioural | Medicaiton adherence therapy |
Primary outcome
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
4 secondary outcomes
level of medication adherence
Time frame: 12 months follow-up
mental status
Time frame: 12 months follow-up
insight into treatment
Time frame: 12 months follow-up
functioning
Time frame: 12 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
- Background: PubMed 24109184Chien 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.
- Results publicationChien, 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.
- Results publication: PubMed 26072311Chien 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.
- Derived from this study: PubMed 26911397Chien 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
WT Chien, PhD principal investigator
The Hogn Kong Polytechnic University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Adherence therapy in people with Schizophrenia and Schizophreniform Disorder, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
re-hospitalization rate (time frame: 12 months after completion of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01780116, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016; AzTrials last refreshed its copy on 1 Nov 2026.