Effects of an Acceptance-based Medication Adherence Therapy for Recent-onset Psychosis
NCT ID: NCT06192602
Last Updated: 2025-08-26
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
126 participants
INTERVENTIONAL
2023-02-01
2025-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
TRIPLE
Study Groups
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Acceptance-based, insight-inducing medication adherence therapy (AIM-AT)
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.
AIM_AT
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.
TAU
Routine/Usual care only (control) group participants (and the two treatment groups) will receive usual community mental healthcare services.
Conventional Psychoeducation Group program (CPG)
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.
CPG
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
Routine/Usual care only (control) group participants (and the two treatment groups) will receive usual community mental healthcare services.
Treatment-as-usual only (TAU)
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.
TAU
Routine/Usual care only (control) group participants (and the two treatment groups) will receive usual community mental healthcare services.
Interventions
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AIM_AT
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.
CPG
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
Routine/Usual care only (control) group participants (and the two treatment groups) will receive usual community mental healthcare services.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
64 Years
ALL
No
Sponsors
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Integrated Community Centers for Mental Wellness
UNKNOWN
Chinese University of Hong Kong
OTHER
Responsible Party
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Prof. Wai Tong CHIEN
Professor
Principal Investigators
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Wai Tong Chien, PhD
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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Integrated Community Centers for Mental Wellness
Hong Kong, New Territories, Hong Kong
Countries
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References
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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.
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.
Other Identifiers
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19202171
Identifier Type: -
Identifier Source: org_study_id
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