NCT06192602

Effects of an Acceptance-based Medication Adherence Therapy for Recent-onset Psychosis

Testing the Effectiveness of an Acceptance-based Adherence Therapy for People With Recent-onset Psychosis: A Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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).

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

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.
BEHAVIORAL	TAU	Routine/Usual care only (control) group participants (and the two treatment groups) will receive usual community mental healthcare services.

Timeline

• Start date: 2023-02-01
• Primary completion: 2026-02-28
• Completion: 2027-01-31
• First posted: 2024-01-05
• Last updated: 2026-03-19

Locations

1 site across 1 country: Hong Kong