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| Name | Class |
|---|---|
| Integrated Community Centers for Mental Wellness | UNKNOWN |
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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).
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 ( \
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIM_AT | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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') |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At immediate post-intervention |
| Drug Attitude Inventory (DAI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wai Tong Chien, PhD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrated Community Centers for Mental Wellness | Hong Kong | New Territories | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26911397 | Background | 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. | |
| 31416744 | Background | Chien 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. |
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The names and emails of researchers can be shared openly for communication and collaboration.
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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Assessor-blind, repeated measures, parallel-group randomized controlled trial
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Outcome assessors, researchers and center staff are blind to the group assignment and intervention undertaken, and concealed to the participant list.
|
| CPG | Behavioral | 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. |
|
| TAU | Behavioral | Routine/Usual care only (control) group participants (and the two treatment groups) will receive usual community mental healthcare services. |
|
| 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') | 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') | At 12 months post-intervention |
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). |
| 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). | 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. | 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. | 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. | 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'). | 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'). | 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'). | 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. | 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. | 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. | 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. | 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. | 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. | 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'). | 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'). | 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'). | At 12 months post-intervention |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |