Effects of an Acceptance-based Medication Adherence Therapy for Recent-onset Psychosis (NCT06192602) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effects of an Acceptance-based Medication Adherence Therapy for Recent-onset Psychosis
Hong Kong126 participantsStarted 2023-02-01
Plain-language 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).
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adherence Rating Scale
Timeframe: Baseline (At recruitment)
2
Adherence Rating Scale
Timeframe: At immediate (1-2 weeks) post-intervention
3
Adherence Rating Scale
Timeframe: At 6 months post-intervention
4
Adherence Rating Scale
Timeframe: At 12 months post-intervention
5
Insight and Treatment Attitude Questionnaire (ITAQ)
Timeframe: At immediate (1-2 weeks) post-intervention
6
Insight and Treatment Attitude Questionnaire (ITAQ)
Timeframe: At 6 months post-intervention
7
Insight and Treatment Attitude Questionnaire (ITAQ)