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

NCT06192602 | Active Not Recruiting DMC

• 1 other identifier: 19202171
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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).

Conditions

Early Psychosis; Psychotic Disorders

Keywords

recent-onset psychosis; randomized controlled trial; insight into illness; acceptance; psychotic symptoms; rehospitalization; medication adherence; service satisfaction

Outcome Measures

Primary Outcomes (7)

• 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')

  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

Secondary Outcomes (18)

• Drug Attitude Inventory (DAI)

  At immediate post-intervention

• Drug Attitude Inventory (DAI)

  At 6 months post-intervention

• Drug Attitude Inventory (DAI)

  At 12 months post-intervention

• Frequency and length/duration of re-hospitalizations

  At immediate post-intervention

• Frequency and length/duration of re-hospitalizations

  At 6 months post-intervention

Study Arms (3)

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.

Behavioral: AIM_AT; Behavioral: TAU

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.

Behavioral: CPG; Behavioral: TAU

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.

Behavioral: TAU

Interventions

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.

Acceptance-based, insight-inducing medication adherence therapy (AIM-AT)

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.

Conventional Psychoeducation Group program (CPG)

TAU BEHAVIORAL

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

Acceptance-based, insight-inducing medication adherence therapy (AIM-AT); Conventional Psychoeducation Group program (CPG); Treatment-as-usual only (TAU)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Integrated Community Centers for Mental Wellness: collaborator

Study Sites (1)

Integrated Community Centers for Mental Wellness

Hong Kong, New Territories, Hong Kong

Location

Related Publications (2)

• 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.

  PMID: 26911397 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.

  PMID: 31416744 BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders; Medication Adherence

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Wai Tong Chien, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors, researchers and center staff are blind to the group assignment and intervention undertaken, and concealed to the participant list.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Assessor-blind, repeated measures, parallel-group randomized controlled trial

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: February 1, 2023
• Primary Completion: February 28, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 19, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)