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

Psychotic Disorders Clinical Trial

— AIM_AT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06192602
• Other study ID #: 19202171
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: December 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 (

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 126
• Est. completion date: May 31, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Early Psychosis
• Mental Disorders
• Psychotic Disorders

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Integrated Community Centers for Mental Wellness	Hong Kong	New Territories

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Integrated Community Centers for Mental Wellness

Country where clinical trial is conducted

Hong Kong, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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