Clinical trial NCT06192602: Effects of an Acceptance-based Medication Adherence Therapy for Recent-onset Psychosis
Official title: Testing the Effectiveness of an Acceptance-based Adherence Therapy for People with Recent-onset Psychosis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Early Psychosis
Psychotic Disorders
Keywords: recent-onset psychosis
randomized controlled trial
insight into illness
acceptance
psychotic symptoms
rehospitalization
medication adherence
service satisfaction
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Integrated Community Centers for Mental Wellness
First posted: 2024-01-05
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assessor-blind, repeated measures, parallel-group randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adherence Rating Scale
timeFrame: Baseline (At recruitment)
measure: Adherence Rating Scale
timeFrame: At immediate (1-2 weeks) post-intervention
measure: Adherence Rating Scale
timeFrame: At 6 months post-intervention
measure: Adherence Rating Scale
timeFrame: At 12 months post-intervention
measure: Insight and Treatment Attitude Questionnaire (ITAQ)
timeFrame: At immediate (1-2 weeks) post-intervention
measure: Insight and Treatment Attitude Questionnaire (ITAQ)
timeFrame: At 6 months post-intervention
measure: Insight and Treatment Attitude Questionnaire (ITAQ)
timeFrame: At 12 months post-intervention
Secondary outcomes:
measure: Drug Attitude Inventory (DAI)
timeFrame: At immediate post-intervention
measure: Drug Attitude Inventory (DAI)
timeFrame: At 6 months post-intervention
measure: Drug Attitude Inventory (DAI)
timeFrame: At 12 months post-intervention
measure: Frequency and length/duration of re-hospitalizations
timeFrame: At immediate post-intervention
measure: Frequency and length/duration of re-hospitalizations
timeFrame: At 6 months post-intervention
measure: Frequency and length/duration of re-hospitalizations
timeFrame: At 12 months post-intervention
measure: Questionnaire about the Process of Recovery (QPR)
timeFrame: At immediate post-intervention
measure: Questionnaire about the Process of Recovery (QPR)
timeFrame: At 6 months post-intervention
measure: Questionnaire about the Process of Recovery (QPR)
timeFrame: At 12 months post-intervention
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: At immediate post-intervention
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: At 6 months post-intervention
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: At 12 months post-intervention
measure: Specific Level of Functioning Scale (SLOF)
timeFrame: At immediate post-intervention
measure: Specific Level of Functioning Scale (SLOF)
timeFrame: At 6 months post-intervention
measure: Specific Level of Functioning Scale (SLOF)
timeFrame: At 12 months post-intervention
measure: Eight-item Client Satisfaction Questionnaire (CSQ-8)
timeFrame: At immediate post-intervention
measure: Eight-item Client Satisfaction Questionnaire (CSQ-8)
timeFrame: At 6 months post-intervention
measure: Eight-item Client Satisfaction Questionnaire (CSQ-8)
timeFrame: At 12 months post-intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Integrated Community Centers for Mental Wellness
state: New Territories
Study officials:
affiliation: Chinese University of Hong Kong
name: Wai Tong Chien, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.