Early Psychosis, Psychotic Disorders
Conditions
Keywords
recent-onset psychosis, randomized controlled trial, insight into illness, acceptance, psychotic symptoms, rehospitalization, medication adherence, service satisfaction
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.
Interventions
BEHAVIORALAIM_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.
BEHAVIORALCPG
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.
BEHAVIORALTAU
Routine/Usual care only (control) group participants (and the two treatment groups) will receive usual community mental healthcare services.
Sponsors
Chinese University of Hong Kong
Integrated Community Centers for Mental Wellness
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
Outcome assessors, researchers and center staff are blind to the group assignment and intervention undertaken, and concealed to the participant list.
Intervention model description
Assessor-blind, repeated measures, parallel-group randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence Rating Scale | Baseline (At recruitment) | 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. |
| Insight and Treatment Attitude Questionnaire (ITAQ) | At immediate (1-2 weeks) post-intervention | 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') |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drug Attitude Inventory (DAI) | At immediate post-intervention | 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). |
| Frequency and length/duration of re-hospitalizations | At immediate post-intervention | 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. |
| Questionnaire about the Process of Recovery (QPR) | At immediate post-intervention | 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'). |
| Positive and Negative Syndrome Scale (PANSS) | At immediate post-intervention | 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. |
| Specific Level of Functioning Scale (SLOF) | At immediate post-intervention | 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. |
| Eight-item Client Satisfaction Questionnaire (CSQ-8) | At immediate post-intervention | 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'). |
Countries
Hong Kong
Contacts
PRINCIPAL_INVESTIGATORWai Tong Chien, PhD
Chinese University of Hong Kong
Outcome results
None listed