Early PsychosisAIM_ATNCT06192602
Effects of an Acceptance-based Medication Adherence Therapy for Recent-onset Psychosis
A study testing AIM_AT, CPG and TAU in people with Early Psychosis and Psychotic Disorders, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This randomized controlled trial aimed to examine the effectiveness of a 10-session acceptance-based, insight-inducing medication adherence therapy (AIM-AT) program for recent-onset psychosis (in addition to usual care) over a 12-month follow-up (i.e., at immediate, 6-month, and 12-month post-intervention). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Early Psychosis, Psychotic Disorders
- What is being tested?
- AIM_AT, CPG and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Feb 2023to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- primarily diagnosed with psychosis (termed recent-onset), including brief, first-episode and other psychotic disorders according to the criteria of the DSM-V (American Psychiatric Association, 2013);
- had the mental illness ≤5 years (defined as recent-onset psychosis in recent literature)
- Hong Kong Chinese residents, aged 18-64 years;
- Global Assessment of Functioning scores ≥51, indicating mild to moderate symptoms and difficulties in psychosocial/occupational functioning (American Psychiatric Association, 2013), thus being mentally stable to comprehend AIM_AT and/or psychoeducation training;
- Unsatisfactory medication adherence as indicated by the Adherence Rating Scale of <2 (Hayward et al.,1995) during screening; and
- Able to read/understand Cantonese/Mandarin.
Who cannot join
- Participated in/have recently been receiving other psychotherapies;
- Having comorbidity of another mental illness (learning disability, cognitive or personality disorder) and/or clinically significant medical disease; and
- Having communication and/or visual/hearing difficulty.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Integrated Community Centers for Mental Wellness
Hong Kong, New Territories
About this study
Official title: Testing the Effectiveness of an Acceptance-based Adherence Therapy for People With Recent-onset Psychosis: A Randomized Controlled Trial
This randomized controlled trial aimed to examine the effectiveness of a 10-session acceptance-based, insight-inducing medication adherence therapy (AIM-AT) program for recent-onset psychosis (in addition to usual care) over a 12-month follow-up (i.e., at immediate, 6-month, and 12-month post-intervention).
Read the detailed description
Objectives: To evaluate the effectiveness of an Acceptance-based, Insight-inducing Medication Adherence Therapy (AIM_ AT) for recent-onset psychosis on patient outcomes over 12-month follow-up, when compared with a standardized psychoeducation group and routine care only.
Focus-group interviews will be performed on purposively selected participants to examine perceived benefits, satisfaction and limitations of the AIM_ AT.
Hypotheses: Compared with psychoeducation group and routine care only, the AIM_AT participants will indicate significantly greater improvements in patients' adherence to anti-psychotic medication and illness/treatment insight and other secondary outcomes (symptom severity, drug attitude, progress of recovery, psychosocial functioning, satisfaction with service, and re-hospitalization rate) at immediate post-intervention, and/or greater improvements in the above outcomes at 6- and 12-month follow-ups.
Design: A multi-center RCT with repeated-measures, three-arm design. Subjects: 126 Chinese patients with recent-onset psychosis ( </= 5 years) randomly selected from four Integrated Community Centers for Mental Wellness and randomly assigned into three study groups.
Instruments/outcome measures: Frequency, length of re-hospitalizations, and total number of patients being hospitalized from clinic records over 5-6 months; valid questionnaires (ARS, ITAQ, DAI, QPR, PANSS, SLOF, CSQ-8) for medication adherence, illness/treatment insight, drug attitude, recovery, symptom severity, functioning, and service satisfaction accordingly. Focus group interviews will collect views on benefits and weaknesses of the AIM_AT.
Data analysis: Comparing the mean value changes of outcomes between groups across time on intention-to-treat basis, using Mixed Modeling/GEE-test; and content analysis of data from focus-group interviews and intervention sessions will be conducted.
Expected results: The findings can provide evidence of the effectiveness of AIM_ AT for early-stage psychosis in community mental healthcare on improving patients' medication adherence, mental condition and recovery, functioning, and service satisfaction.
- Conditions
- Early Psychosis, Psychotic Disorders
- Being tested
- AIM_AT, CPG, TAU
- Keywords
- recent-onset psychosis, randomized controlled trial, insight into illness, acceptance, psychotic symptoms, rehospitalization, medication adherence, service satisfaction
- Medical subject headings
- Psychotic Disorders, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIM_ATBehavioural
The program consists of 10 weekly/biweekly, 2-hour sessions (4-months), based on the modified Kemp's model/manual of Adherence therapy and mindfulness-based psychoeducation program developed by the research team.
CPGBehavioural
Psychoeducation group program (12-18 members/group) consists of 10 two-hour sessions, weekly/biweekly (similarly, 4-month duration) and is guided by a validated group-intervention protocol based on the research team's and McFarlane et al.'s psychoeducation programs for psychosis.
TAUBehavioural
Routine/Usual care only (control) group participants (and the two treatment groups) will receive usual community mental healthcare services.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance-based, insight-inducing medication adherence therapy (AIM-AT) | Experimental | Acceptance-based Insight-inducing and Medication Adherence Therapy (AIM_AT) consists of 10 weekly/biweekly, 2-hour sessions (4-months), based on the modified Kemp's model/manual of Adherence therapy and mindfulness-based psychoeducation program developed by the research team. The integrative AIM_AT program based on the principles of motivational-interviewing technique (MI) and mindfulness- and acceptance-based therapy, which have been tested in our previous controlled trials and increasingly been shown to reduce both positive and negative psychotic symptoms and ambivalent attitude towards medication adherence and inducing treatment/illness insight. Receives: Behavioral: AIM_AT; Behavioral: TAU |
| Conventional Psychoeducation Group program (CPG) | Active comparator | Psychoeducation groups (12-18 members/group) will be led by one trained psychiatric nurse in each center experienced in psychiatric rehabilitation, and are guided by a validated group-intervention protocol based on the research team's and McFarlane et al.'s psychoeducation programs for psychosis. The psychoeducation program consists of 10 two-hour sessions, weekly/biweekly (similarly, 4-month duration) and is comprised of six components: introduction and goal-setting; basic understanding of psychosis and symptom and emotion self-care; education workshop of psychosis care, treatment and community support services; learning about self-care skills; establishing social support and effective coping skills; and skills practices, review and future plan. Receives: Behavioral: CPG; Behavioral: TAU |
| Treatment-as-usual only (TAU) | Other | Routine/Usual care only (control) group participants (and the two treatment groups) will receive usual community mental healthcare services. The main services provided by the four ICCMWs mainly include day-time occupational and living skills training workshops, family mutual support groups, public and mental health education, social and recreational services, supportive groups services on specific mental health problems, referrals to community psychiatric and social care services, and individual and family counseling service as needed. In addition, the center users will also receive community mental health services provided by public hospital and outpatient departments. Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence Rating Scale
Rating (by RA and checking against patient records and center staff) on the level of medication adherence on a 5-point Likert-scale (1-'total non-adherence'; 2-' poor adherence'; 3-'inadequate adherence'; 4-'fair adherence'; and 5-'good adherence') with excellent inter-rater reliability and content validity.
Measured: Baseline (At recruitment)
Adherence Rating Scale
Rating (by RA and checking against patient records and center staff) on the level of medication adherence on a 5-point Likert-scale (1-'total non-adherence'; 2-' poor adherence'; 3-'inadequate adherence'; 4-'fair adherence'; and 5-'good adherence') with excellent inter-rater reliability and content validity.
Measured: At immediate (1-2 weeks) post-intervention
Adherence Rating Scale
Rating (by RA and checking against patient records and center staff) on the level of medication adherence on a 5-point Likert-scale (1-'total non-adherence'; 2-' poor adherence'; 3-'inadequate adherence'; 4-'fair adherence'; and 5-'good adherence') with excellent inter-rater reliability and content validity.
Measured: At 6 months post-intervention
Adherence Rating Scale
Rating (by RA and checking against patient records and center staff) on the level of medication adherence on a 5-point Likert-scale (1-'total non-adherence'; 2-' poor adherence'; 3-'inadequate adherence'; 4-'fair adherence'; and 5-'good adherence') with excellent inter-rater reliability and content validity.
Measured: At 12 months post-intervention
Insight and Treatment Attitude Questionnaire (ITAQ)
The 10-item ITAQ was developed by McEvoy et al.(1989) to measure patients' insight and recognition of their illness and attitudes towards treatment/medication needs. Items are rated on 3-point Likert-scale (0= 'Not necessary to receive medication/treatment' to 2= 'Medication/treatment continued/required regularly')
Measured: At immediate (1-2 weeks) post-intervention
Insight and Treatment Attitude Questionnaire (ITAQ)
The 10-item ITAQ was developed by McEvoy et al.(1989) to measure patients' insight and recognition of their illness and attitudes towards treatment/medication needs. Items are rated on 3-point Likert-scale (0= 'Not necessary to receive medication/treatment' to 2= 'Medication/treatment continued/required regularly')
Measured: At 6 months post-intervention
Insight and Treatment Attitude Questionnaire (ITAQ)
The 10-item ITAQ was developed by McEvoy et al.(1989) to measure patients' insight and recognition of their illness and attitudes towards treatment/medication needs. Items are rated on 3-point Likert-scale (0= 'Not necessary to receive medication/treatment' to 2= 'Medication/treatment continued/required regularly')
Measured: At 12 months post-intervention
Secondary outcomes (18)
Drug Attitude Inventory (DAI)
The DAI is a 10-item self-report scale measuring one's attitude towards drug adherence (equally balanced for True/False items) and containing two subscales (subjective positive and subjective negative attitude).
Measured: At immediate post-intervention
Drug Attitude Inventory (DAI)
The DAI is a 10-item self-report scale measuring one's attitude towards drug adherence (equally balanced for True/False items) and containing two subscales (subjective positive and subjective negative attitude).
Measured: At 6 months post-intervention
Drug Attitude Inventory (DAI)
The DAI is a 10-item self-report scale measuring one's attitude towards drug adherence (equally balanced for True/False items) and containing two subscales (subjective positive and subjective negative attitude).
Measured: At 12 months post-intervention
Frequency and length/duration of re-hospitalizations
Frequency and length/duration of re-hospitalizations over past 5-6 months will be reported by participants at baseline and post-tests, and checked with their center records.
Measured: At immediate post-intervention
Frequency and length/duration of re-hospitalizations
Frequency and length/duration of re-hospitalizations over past 5-6 months will be reported by participants at baseline and post-tests, and checked with their center records.
Measured: At 6 months post-intervention
Frequency and length/duration of re-hospitalizations
Frequency and length/duration of re-hospitalizations over past 5-6 months will be reported by participants at baseline and post-tests, and checked with their center records.
Measured: At 12 months post-intervention
Questionnaire about the Process of Recovery (QPR)
The QPR (Chinese version) consists of 22 items and 3 subscales (Self-empowerment [10-items]; Effective interpersonal relationships [6-items]; Rebuilding life [6-items]), rating on a 5-point Likert-scale ('0= disagree strongly' to '4= agree strongly').
Measured: At immediate post-intervention
Questionnaire about the Process of Recovery (QPR)
The QPR (Chinese version) consists of 22 items and 3 subscales (Self-empowerment [10-items]; Effective interpersonal relationships [6-items]; Rebuilding life [6-items]), rating on a 5-point Likert-scale ('0= disagree strongly' to '4= agree strongly').
Measured: At 6 months post-intervention
Questionnaire about the Process of Recovery (QPR)
The QPR (Chinese version) consists of 22 items and 3 subscales (Self-empowerment [10-items]; Effective interpersonal relationships [6-items]; Rebuilding life [6-items]), rating on a 5-point Likert-scale ('0= disagree strongly' to '4= agree strongly').
Measured: At 12 months post-intervention
Positive and Negative Syndrome Scale (PANSS)
Mental state/Symptom severity is assessed with the 30-item PANSS(Kay 1987) across three subscales (positive symptoms, negative symptoms and general psychopathology). The scale is rated on a 7-point Likert-scale (1-'absent' to 7-'extreme'), for symptom severity.
Measured: At immediate post-intervention
Positive and Negative Syndrome Scale (PANSS)
Mental state/Symptom severity is assessed with the 30-item PANSS(Kay 1987) across three subscales (positive symptoms, negative symptoms and general psychopathology). The scale is rated on a 7-point Likert-scale (1-'absent' to 7-'extreme'), for symptom severity.
Measured: At 6 months post-intervention
Positive and Negative Syndrome Scale (PANSS)
Mental state/Symptom severity is assessed with the 30-item PANSS(Kay 1987) across three subscales (positive symptoms, negative symptoms and general psychopathology). The scale is rated on a 7-point Likert-scale (1-'absent' to 7-'extreme'), for symptom severity.
Measured: At 12 months post-intervention
Specific Level of Functioning Scale (SLOF)
Patient functioning is measured by the 43-item SLOF (Schneider and Struening, 1983) in terms of three domains: physical functioning/personal care (12 items), social functioning (14 items) and community living skills (17 items) of psychosis sufferers, on 5-point Likert-scales.
Measured: At immediate post-intervention
Specific Level of Functioning Scale (SLOF)
Patient functioning is measured by the 43-item SLOF (Schneider and Struening, 1983) in terms of three domains: physical functioning/personal care (12 items), social functioning (14 items) and community living skills (17 items) of psychosis sufferers, on 5-point Likert-scales.
Measured: At 6 months post-intervention
Specific Level of Functioning Scale (SLOF)
Patient functioning is measured by the 43-item SLOF (Schneider and Struening, 1983) in terms of three domains: physical functioning/personal care (12 items), social functioning (14 items) and community living skills (17 items) of psychosis sufferers, on 5-point Likert-scales.
Measured: At 12 months post-intervention
Eight-item Client Satisfaction Questionnaire (CSQ-8)
The CSQ-8 is well-accepted valid questionnaire to evaluate service users' opinions/conclusions about services received/receiving. Items are rated on 4-point Likert-scale (1- 'very dissatisfied' to 4- 'very satisfied').
Measured: At immediate post-intervention
Eight-item Client Satisfaction Questionnaire (CSQ-8)
The CSQ-8 is well-accepted valid questionnaire to evaluate service users' opinions/conclusions about services received/receiving. Items are rated on 4-point Likert-scale (1- 'very dissatisfied' to 4- 'very satisfied').
Measured: At 6 months post-intervention
Eight-item Client Satisfaction Questionnaire (CSQ-8)
The CSQ-8 is well-accepted valid questionnaire to evaluate service users' opinions/conclusions about services received/receiving. Items are rated on 4-point Likert-scale (1- 'very dissatisfied' to 4- 'very satisfied').
Measured: At 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Feb 2023
- Primary completion28 Feb 2026
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Early PsychosisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assessor-blind, repeated measures, parallel-group randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Integrated Community Centers for Mental Wellness, Hong Kong
- Responsible party
- Principal investigator, Prof. Wai Tong CHIEN, Chinese University of Hong Kong
- Investigators
- Wai Tong Chien, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192602
- Sponsor's protocol ID
- 19202171
- Acronym
- AIM_AT
- Status last verified
- Aug 2025
- First submitted
- 21 Dec 2023
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The names and emails of researchers can be shared openly for communication and collaboration.
Publications
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.
PubMed 26911397Chien WT, Cheng HY, McMaster TW, Yip ALK, Wong JCL. Effectiveness of a mindfulness-based psychoeducation group programme for early-stage schizophrenia: An 18-month randomised controlled trial. Schizophr Res. 2019 Oct;212:140-149. doi: 10.1016/j.schres.2019.07.053. Epub 2019 Aug 12.
PubMed 31416744Chien WT, Chong YY, Bressington D, McMaster CW. A randomized controlled trial of an acceptance-based, insight-inducing medication adherence therapy (AIM-AT) for adults with early-stage psychosis. Psychiatry Res. 2024 Sep;339:116046. doi: 10.1016/j.psychres.2024.116046. Epub 2024 Jun 17.
PubMed 38908265
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness of an Acceptance-based Adherence Therapy for People With Recent-onset Psychosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06192602
- Acronym / sponsor ID
- AIM_AT / 19202171
- Conditions
- Early Psychosis, Psychotic Disorders
- Keywords
- recent-onset psychosis, randomized controlled trial, insight into illness, acceptance, psychotic symptoms, rehospitalization, medication adherence, service satisfaction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Integrated Community Centers for Mental Wellness, Hong Kong
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 5 Jan 2024 (actual)
- 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.
This randomized controlled trial aimed to examine the effectiveness of a 10-session acceptance-based, insight-inducing medication adherence therapy (AIM-AT) program for recent-onset psychosis (in addition to usual care) over a 12-month follow-up (i.e., at immediate, 6-month, and 12-month post-intervention).
Detailed description
Objectives: To evaluate the effectiveness of an Acceptance-based, Insight-inducing Medication Adherence Therapy (AIM_ AT) for recent-onset psychosis on patient outcomes over 12-month follow-up, when compared with a standardized psychoeducation group and routine care only.
Focus-group interviews will be performed on purposively selected participants to examine perceived benefits, satisfaction and limitations of the AIM_ AT.
Hypotheses: Compared with psychoeducation group and routine care only, the AIM_AT participants will indicate significantly greater improvements in patients' adherence to anti-psychotic medication and illness/treatment insight and other secondary outcomes (symptom severity, drug attitude, progress of recovery, psychosocial functioning, satisfaction with service, and re-hospitalization rate) at immediate post-intervention, and/or greater improvements in the above outcomes at 6- and 12-month follow-ups.
Design: A multi-center RCT with repeated-measures, three-arm design. Subjects: 126 Chinese patients with recent-onset psychosis ( </= 5 years) randomly selected from four Integrated Community Centers for Mental Wellness and randomly assigned into three study groups.
Instruments/outcome measures: Frequency, length of re-hospitalizations, and total number of patients being hospitalized from clinic records over 5-6 months; valid questionnaires (ARS, ITAQ, DAI, QPR, PANSS, SLOF, CSQ-8) for medication adherence, illness/treatment insight, drug attitude, recovery, symptom severity, functioning, and service satisfaction accordingly. Focus group interviews will collect views on benefits and weaknesses of the AIM_AT.
Data analysis: Comparing the mean value changes of outcomes between groups across time on intention-to-treat basis, using Mixed Modeling/GEE-test; and content analysis of data from focus-group interviews and intervention sessions will be conducted.
Expected results: The findings can provide evidence of the effectiveness of AIM_ AT for early-stage psychosis in community mental healthcare on improving patients' medication adherence, mental condition and recovery, functioning, and service satisfaction.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Assessor-blind, repeated measures, parallel-group randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Acceptance-based, insight-inducing medication adherence therapy (AIM-AT) | Experimental | Behavioral: AIM_AT, Behavioral: TAUAcceptance-based Insight-inducing and Medication Adherence Therapy (AIM_AT) consists of 10 weekly/biweekly, 2-hour sessions (4-months), based on the modified Kemp's model/manual of Adherence therapy and mindfulness-based psychoeducation program developed by the research team. The integrative AIM_AT program based on the principles of motivational-interviewing technique (MI) and mindfulness- and acceptance-based therapy, which have been tested in our previous controlled trials and increasingly been shown to reduce both positive and negative psychotic symptoms and ambivalent attitude towards medication adherence and inducing treatment/illness insight. |
| Conventional Psychoeducation Group program (CPG) | Active comparator | Behavioral: CPG, Behavioral: TAUPsychoeducation groups (12-18 members/group) will be led by one trained psychiatric nurse in each center experienced in psychiatric rehabilitation, and are guided by a validated group-intervention protocol based on the research team's and McFarlane et al.'s psychoeducation programs for psychosis. The psychoeducation program consists of 10 two-hour sessions, weekly/biweekly (similarly, 4-month duration) and is comprised of six components: introduction and goal-setting; basic understanding of psychosis and symptom and emotion self-care; education workshop of psychosis care, treatment and community support services; learning about self-care skills; establishing social support and effective coping skills; and skills practices, review and future plan. |
| Treatment-as-usual only (TAU) | Other | Behavioral: TAURoutine/Usual care only (control) group participants (and the two treatment groups) will receive usual community mental healthcare services. The main services provided by the four ICCMWs mainly include day-time occupational and living skills training workshops, family mutual support groups, public and mental health education, social and recreational services, supportive groups services on specific mental health problems, referrals to community psychiatric and social care services, and individual and family counseling service as needed. In addition, the center users will also receive community mental health services provided by public hospital and outpatient departments. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- primarily diagnosed with psychosis (termed recent-onset), including brief, first-episode and other psychotic disorders according to the criteria of the DSM-V (American Psychiatric Association, 2013);
- had the mental illness ≤5 years (defined as recent-onset psychosis in recent literature)
- Hong Kong Chinese residents, aged 18-64 years;
- Global Assessment of Functioning scores ≥51, indicating mild to moderate symptoms and difficulties in psychosocial/occupational functioning (American Psychiatric Association, 2013), thus being mentally stable to comprehend AIM_AT and/or psychoeducation training;
- Unsatisfactory medication adherence as indicated by the Adherence Rating Scale of <2 (Hayward et al.,1995) during screening; and
Key exclusion criteria (3 listed)
- Participated in/have recently been receiving other psychotherapies;
- Having comorbidity of another mental illness (learning disability, cognitive or personality disorder) and/or clinically significant medical disease; and
- Having communication and/or visual/hearing difficulty.
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 |
|---|---|---|
| AIM_ATThe program consists of 10 weekly/biweekly, 2-hour sessions (4-months), based on the modified Kemp's model/manual of Adherence therapy and mindfulness-based psychoeducation program developed by the research team. | Behavioural | Acceptance-based, insight-inducing medication adherence therapy (AIM-AT) |
| CPGPsychoeducation group program (12-18 members/group) consists of 10 two-hour sessions, weekly/biweekly (similarly, 4-month duration) and is guided by a validated group-intervention protocol based on the research team's and McFarlane et al.'s psychoeducation programs for psychosis. | Behavioural | Conventional Psychoeducation Group program (CPG) |
| TAURoutine/Usual care only (control) group participants (and the two treatment groups) will receive usual community mental healthcare services. | Behavioural | Acceptance-based, insight-inducing medication adherence therapy (AIM-AT), Conventional Psychoeducation Group program (CPG), Treatment-as-usual only (TAU) |
Primary outcome
Adherence Rating Scale
Time frame: Baseline (At recruitment)
Rating (by RA and checking against patient records and center staff) on the level of medication adherence on a 5-point Likert-scale (1-'total non-adherence'; 2-' poor adherence'; 3-'inadequate adherence'; 4-'fair adherence'; and 5-'good adherence') with excellent inter-rater reliability and content validity.
Adherence Rating Scale
Time frame: At immediate (1-2 weeks) post-intervention
Rating (by RA and checking against patient records and center staff) on the level of medication adherence on a 5-point Likert-scale (1-'total non-adherence'; 2-' poor adherence'; 3-'inadequate adherence'; 4-'fair adherence'; and 5-'good adherence') with excellent inter-rater reliability and content validity.
Adherence Rating Scale
Time frame: At 6 months post-intervention
Rating (by RA and checking against patient records and center staff) on the level of medication adherence on a 5-point Likert-scale (1-'total non-adherence'; 2-' poor adherence'; 3-'inadequate adherence'; 4-'fair adherence'; and 5-'good adherence') with excellent inter-rater reliability and content validity.
Adherence Rating Scale
Time frame: At 12 months post-intervention
Rating (by RA and checking against patient records and center staff) on the level of medication adherence on a 5-point Likert-scale (1-'total non-adherence'; 2-' poor adherence'; 3-'inadequate adherence'; 4-'fair adherence'; and 5-'good adherence') with excellent inter-rater reliability and content validity.
Insight and Treatment Attitude Questionnaire (ITAQ)
Time frame: At immediate (1-2 weeks) post-intervention
The 10-item ITAQ was developed by McEvoy et al.(1989) to measure patients' insight and recognition of their illness and attitudes towards treatment/medication needs. Items are rated on 3-point Likert-scale (0= 'Not necessary to receive medication/treatment' to 2= 'Medication/treatment continued/required regularly')
Insight and Treatment Attitude Questionnaire (ITAQ)
Time frame: At 6 months post-intervention
The 10-item ITAQ was developed by McEvoy et al.(1989) to measure patients' insight and recognition of their illness and attitudes towards treatment/medication needs. Items are rated on 3-point Likert-scale (0= 'Not necessary to receive medication/treatment' to 2= 'Medication/treatment continued/required regularly')
Insight and Treatment Attitude Questionnaire (ITAQ)
Time frame: At 12 months post-intervention
The 10-item ITAQ was developed by McEvoy et al.(1989) to measure patients' insight and recognition of their illness and attitudes towards treatment/medication needs. Items are rated on 3-point Likert-scale (0= 'Not necessary to receive medication/treatment' to 2= 'Medication/treatment continued/required regularly')
18 secondary outcomes
Drug Attitude Inventory (DAI)
Time frame: At immediate post-intervention
Drug Attitude Inventory (DAI)
Time frame: At 6 months post-intervention
Drug Attitude Inventory (DAI)
Time frame: At 12 months post-intervention
Frequency and length/duration of re-hospitalizations
Time frame: At immediate post-intervention
Frequency and length/duration of re-hospitalizations
Time frame: At 6 months post-intervention
Frequency and length/duration of re-hospitalizations
Time frame: At 12 months post-intervention
Questionnaire about the Process of Recovery (QPR)
Time frame: At immediate post-intervention
Questionnaire about the Process of Recovery (QPR)
Time frame: At 6 months post-intervention
Questionnaire about the Process of Recovery (QPR)
Time frame: At 12 months post-intervention
Positive and Negative Syndrome Scale (PANSS)
Time frame: At immediate post-intervention
Positive and Negative Syndrome Scale (PANSS)
Time frame: At 6 months post-intervention
Positive and Negative Syndrome Scale (PANSS)
Time frame: At 12 months post-intervention
Specific Level of Functioning Scale (SLOF)
Time frame: At immediate post-intervention
Specific Level of Functioning Scale (SLOF)
Time frame: At 6 months post-intervention
Specific Level of Functioning Scale (SLOF)
Time frame: At 12 months post-intervention
Eight-item Client Satisfaction Questionnaire (CSQ-8)
Time frame: At immediate post-intervention
Eight-item Client Satisfaction Questionnaire (CSQ-8)
Time frame: At 6 months post-intervention
Eight-item Client Satisfaction Questionnaire (CSQ-8)
Time frame: At 12 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: 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.
- Background: PubMed 31416744Chien WT, Cheng HY, McMaster TW, Yip ALK, Wong JCL. Effectiveness of a mindfulness-based psychoeducation group programme for early-stage schizophrenia: An 18-month randomised controlled trial. Schizophr Res. 2019 Oct;212:140-149. doi: 10.1016/j.schres.2019.07.053. Epub 2019 Aug 12.
- Derived from this study: PubMed 38908265Chien WT, Chong YY, Bressington D, McMaster CW. A randomized controlled trial of an acceptance-based, insight-inducing medication adherence therapy (AIM-AT) for adults with early-stage psychosis. Psychiatry Res. 2024 Sep;339:116046. doi: 10.1016/j.psychres.2024.116046. Epub 2024 Jun 17.
- Individual participant dataSharing planned: No. The names and emails of researchers can be shared openly for communication and collaboration.
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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.
Wai Tong Chien, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AIM_AT, CPG and TAU in people with Early Psychosis and Psychotic Disorders, run by Chinese University of Hong Kong at 1 site 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 6 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Adherence Rating Scale (time frame: Baseline (At recruitment)). The study lists 7 primary outcomes in all. 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 NCT06192602, which also lists 3 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 Mar 2026.