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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Psychotic Disorders; Early Psychosis
• Intervention / Treatment: Behavioral: AIM_AT; Behavioral: TAU; Behavioral: CPG

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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • New Territories
    • Hong Kong, New Territories, Hong Kong
      • Integrated Community Centers for Mental Wellness

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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: TAU; Routine/Usual care only (control) group participants (and the two treatment groups) will receive usual community mental healthcare services.
Active Comparator: 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.	Behavioral: TAU; Routine/Usual care only (control) group participants (and the two treatment groups) will receive usual community mental healthcare services.; 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.
Other: 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.	Behavioral: TAU; Routine/Usual care only (control) group participants (and the two treatment groups) will receive usual community mental healthcare services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug Attitude Inventory (DAI)	The DAI is a 10-item self-report scale measuring one's attitude towards drug adherence (equally balanced for True/False items) and containing two subscales (subjective positive and subjective negative attitude).	At immediate post-intervention
Drug Attitude Inventory (DAI)	The DAI is a 10-item self-report scale measuring one's attitude towards drug adherence (equally balanced for True/False items) and containing two subscales (subjective positive and subjective negative attitude).	At 6 months post-intervention
Drug Attitude Inventory (DAI)	The DAI is a 10-item self-report scale measuring one's attitude towards drug adherence (equally balanced for True/False items) and containing two subscales (subjective positive and subjective negative attitude).	At 12 months post-intervention
Frequency and length/duration of re-hospitalizations	Frequency and length/duration of re-hospitalizations over past 5-6 months will be reported by participants at baseline and post-tests, and checked with their center records.	At immediate post-intervention
Frequency and length/duration of re-hospitalizations	Frequency and length/duration of re-hospitalizations over past 5-6 months will be reported by participants at baseline and post-tests, and checked with their center records.	At 6 months post-intervention
Frequency and length/duration of re-hospitalizations	Frequency and length/duration of re-hospitalizations over past 5-6 months will be reported by participants at baseline and post-tests, and checked with their center records.	At 12 months post-intervention
Questionnaire about the Process of Recovery (QPR)	The QPR (Chinese version) consists of 22 items and 3 subscales (Self-empowerment [10-items]; Effective interpersonal relationships [6-items]; Rebuilding life [6-items]), rating on a 5-point Likert-scale ('0= disagree strongly' to '4= agree strongly').	At immediate post-intervention
Questionnaire about the Process of Recovery (QPR)	The QPR (Chinese version) consists of 22 items and 3 subscales (Self-empowerment [10-items]; Effective interpersonal relationships [6-items]; Rebuilding life [6-items]), rating on a 5-point Likert-scale ('0= disagree strongly' to '4= agree strongly').	At 6 months post-intervention
Questionnaire about the Process of Recovery (QPR)	The QPR (Chinese version) consists of 22 items and 3 subscales (Self-empowerment [10-items]; Effective interpersonal relationships [6-items]; Rebuilding life [6-items]), rating on a 5-point Likert-scale ('0= disagree strongly' to '4= agree strongly').	At 12 months post-intervention
Positive and Negative Syndrome Scale (PANSS)	Mental state/Symptom severity is assessed with the 30-item PANSS(Kay 1987) across three subscales (positive symptoms, negative symptoms and general psychopathology). The scale is rated on a 7-point Likert-scale (1-'absent' to 7-'extreme'), for symptom severity.	At immediate post-intervention
Positive and Negative Syndrome Scale (PANSS)	Mental state/Symptom severity is assessed with the 30-item PANSS(Kay 1987) across three subscales (positive symptoms, negative symptoms and general psychopathology). The scale is rated on a 7-point Likert-scale (1-'absent' to 7-'extreme'), for symptom severity.	At 6 months post-intervention
Positive and Negative Syndrome Scale (PANSS)	Mental state/Symptom severity is assessed with the 30-item PANSS(Kay 1987) across three subscales (positive symptoms, negative symptoms and general psychopathology). The scale is rated on a 7-point Likert-scale (1-'absent' to 7-'extreme'), for symptom severity.	At 12 months post-intervention
Specific Level of Functioning Scale (SLOF)	Patient functioning is measured by the 43-item SLOF (Schneider and Struening, 1983) in terms of three domains: physical functioning/personal care (12 items), social functioning (14 items) and community living skills (17 items) of psychosis sufferers, on 5-point Likert-scales.	At immediate post-intervention
Specific Level of Functioning Scale (SLOF)	Patient functioning is measured by the 43-item SLOF (Schneider and Struening, 1983) in terms of three domains: physical functioning/personal care (12 items), social functioning (14 items) and community living skills (17 items) of psychosis sufferers, on 5-point Likert-scales.	At 6 months post-intervention
Specific Level of Functioning Scale (SLOF)	Patient functioning is measured by the 43-item SLOF (Schneider and Struening, 1983) in terms of three domains: physical functioning/personal care (12 items), social functioning (14 items) and community living skills (17 items) of psychosis sufferers, on 5-point Likert-scales.	At 12 months post-intervention
Eight-item Client Satisfaction Questionnaire (CSQ-8)	The CSQ-8 is well-accepted valid questionnaire to evaluate service users' opinions/conclusions about services received/receiving. Items are rated on 4-point Likert-scale (1- 'very dissatisfied' to 4- 'very satisfied').	At immediate post-intervention
Eight-item Client Satisfaction Questionnaire (CSQ-8)	The CSQ-8 is well-accepted valid questionnaire to evaluate service users' opinions/conclusions about services received/receiving. Items are rated on 4-point Likert-scale (1- 'very dissatisfied' to 4- 'very satisfied').	At 6 months post-intervention
Eight-item Client Satisfaction Questionnaire (CSQ-8)	The CSQ-8 is well-accepted valid questionnaire to evaluate service users' opinions/conclusions about services received/receiving. Items are rated on 4-point Likert-scale (1- 'very dissatisfied' to 4- 'very satisfied').	At 12 months post-intervention

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: Integrated Community Centers for Mental Wellness
• Investigators: Principal Investigator: Wai Tong Chien, PhD, Chinese University of Hong Kong

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: randomized controlled trial; psychotic symptoms; medication adherence; rehospitalization; acceptance; recent-onset psychosis; insight into illness; service satisfaction
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: 19202171

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The names and emails of researchers can be shared openly for communication and collaboration.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No