Clinical trial NCT02275390: Nurse-led Psycho-education Program for People With First-onset Mental Illness (APN-PEP)
Official title: Effects of a Nurse-led Psycho-education Program for People With First-onset Mental Illness in Psychiatric Outpatient Clinic: A Randomized Controlled Trial (Effects of SPBB for Family Caregivers in Psychosis)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Illness
Keywords: psychosis
self-learning
problem solving
randomized controlled trial
family carer
recent-onset psychosis
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: United Christian Hospital
First posted: 2014-10-27
Enrollment: 180
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: Repeated measures, two-arm design

\[SPBB: A repeated-measures, two-arm design with 112 outpatients and their family caregivers\]
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study aims to test the effectiveness of a nurse-led psycho-education program based on motivational interviewing technique for Chinese patients with first-onset mental illness over a 12-month follow-up. A randomized controlled trial will be conducted with 180 Chinese patients with schizophrenia newly referred to one outpatient clinic in Hong Kong. They will be randomly assigned to either the eight-session nurse-led psycho-education program or usual psychiatric outpatient care (both n=90). The patients' general and mental health, illness insight, self-efficacy, services utilization, and hospitalization rates were measured at recruitment and one week, six months and 12 months post-intervention.

Note: Those who were approached in the clinic and not eligible to participate in this trial will be invited to participate in another controlled trial. The controlled trial tests the effects of a self-help problem-solving based bibliotherapy program (SPBB) for Chinese family caregivers in recent onset psychosis (not more than 1 year onset) at one psychiatric clinic, in comparison to routine outpatient service and family support (control group) for 116 randomly selected family caregivers of outpatients with psychotic disorders over a 6-month follow-up.)

Detailed description: The development of APNs in Hong Kong is in line with nursing development internationally. Since 2001, the Hospital Authority has appointed about 530 nurses as APNs, in whom about 50 are in mental health practice. Five of these psychiatric APNs function independently and interdependently with other health care team members to excel to health educators and care coordinators with fulfilments in health assessment, education and care coordination for clients with noticeable mental health problems, being referred to psychiatric outpatient service. A structured one-to-one psycho-education program has been developed and trial run to provide early psychiatric and psychosocial intervention and support to the clients who have been triaged by the psychiatric nurses in two outpatient clinics in the Kowloon East Cluster as categorised as those who present noticeable mental symptoms but low risks of self-harm or violence. These clients are arranged to have their first psychiatrist consultation in the clinic within two to eight weeks following triage. Prior to the consultation appointment, they are referred to the psychiatric APN in the nurse-led clinic for providing further psychosocial health assessment and early intervention and psychological support. As estimated by the clinic staff, there are 60% of the clients (i.e. 60 cases per month) triaged and classified as such category in the two outpatient clinics.

This study aims to evaluate the effectiveness of the one-to-one, nurse-led psycho-education program provided by the psychiatric APN for those newly referred clients with mental health problems on improving their mental and emotional conditions, quality of life, and satisfaction with service, and on reducing their rates of hospitalization and default follow-up in two psychiatric outpatient clinics (OPD) in Kowloon East region of Hong Kong.

Objectives of the study

1. To investigate the effects of the nurse-led psycho-education program for newly referred clients with mental health problems triaged as Category 2 on improving their mental state, anxiety state, insight and treatment attitude, self-efficacy in life situations, general health, and utilisation of and satisfaction with mental health care services provided over a period of 12 months follow-up; and
2. To investigate the effects of the nurse-led psycho-education program on reducing the clients' rate of hospitalization and default follow-up in the psychiatric OPD over the 12-month follow-up.

\[Note: Those are not eligible to participate in this trial will be assessed by an Advanced Practice Nurse to join the randomised controlled trial with repeated measures, parallel-group (2-arm) design will be carried out at one psychiatric clinic. This pilot trial aims to evaluate the effects between the treatment group (i.e., a problem-solving based self-learning program, SPBB) and routine outpatient service (control group) for 116 randomly selected family caregivers of outpatients with recent-onset psychosis over a 6-month follow-up. The study outcomes include the caregivers' burden of care, caregiving experiences, and problem-solving abilities, and the patients' mental state, functioning, and re-hospitalization rates. They will be measured at recruitment, one week, and 6 months following the interventions. Objectives of the study are: 1. To investigate the effects of the SPBB program for family caregivers of recent onset psychosis on improving their caregivers' burden of care, caregiving experiences, and problem-solving abilities, and the patients' mental state, and functioning over a period of 6 months follow-up; and 2. To investigate the effects of the SPBB program on reducing the clients' rate of hospitalization and default follow-ups in the psychiatric outpatient clinic over the 6-month follow-up.

Eligibility criteria: Inclusion Criteria:

* aged 18-60 years, able to understand Cantonese/Mandarin;
* having the first-onset of the mental illness (psychotic and mood disorders) within the past six months and new referral or contact with mental healthcare services;
* presenting at least moderate to high levels of psychiatric symptoms (i.e., Brief Psychiatric Rating Scale score of \>25 out of 126 and/or Chinese version of the Beck's Depression Inventory-II scores of \>10 out of 63); and
* indicating no history and low risk of suicide and self-harm.

Exclusion Criteria:

* receiving other psychosocial interventions organized by the clinics or other healthcare organizations; and
* being classified as the highest priority of psychiatric consultation and treatment (i.e., starting their treatment and care plan with their attending psychiatrist and clinic nurse within one week).

\[Note: For SPBB study, the inclusion Criteria of the participants include those who are: Hong Kong Chinese residents, aged 18-64; taking care of and living with a family member primarily diagnosed with one psychotic disorder in the past 12 months psychosis will be recruited; able to read and understand Cantonese/Mandarin; and perceived a moderate to high burden of care (measured by Family Burden Interview Schedule (\>20 out of 50 scores). Exclusion criteria of family caregivers include those: received or are receiving another family intervention; are having cognitive impairment or learning disability; and/or presented with a recent personal history of a serious mental illness or medical disease that may adversely affect their ability to participate in the intervention.\]

Primary outcomes:
measure: Perceived burden of care (Chinese version of Family Burden Interview Schedule)
timeFrame: 6 months after completion of intervention [SPBB study only]
measure: Experience of caregiving (Chinese version of Experience of Caregiving Inventory)
timeFrame: 6 months after completion of intervention [SPBB study only]
measure: Brief Psychiatric Rating Scale
timeFrame: 12 months after completion of intervention
Secondary outcomes:
measure: Coping style (42-item Revised Ways of Coping Checklist)
timeFrame: 6 months after completion of intervention [SPBB only]
measure: Social Problem-Solving (Chinese version of Revised (Short) Social Problem-Solving
timeFrame: 6 months after completion of intervention [SPBB only]
measure: Mental state (Positive and Negative Syndrome Scale)
timeFrame: 6 months after completion of intervention [SPBB only]
measure: Hospitalization and Default Follow-up Rate
timeFrame: 12 months after completion of intervention [6 months in SPBB study]
measure: Patient functioning (43-item Specific Level of Functioning Scale)
timeFrame: 6 months after completion of intervention [SPBB only]
measure: Insight and Treatment Attitudes Questionnaire (APN-PEP)
timeFrame: 12 months after completion of intervention
measure: World Health Organisation Quality of Life Measure - Brief Version
timeFrame: 12 months after completion of intervention
measure: Perceived Self-efficacy Scale
timeFrame: 12 months after completion of intervention
Other outcomes:
Locations:
city: Tai Po
country: Hong Kong
facility: United Christian Psychiatric OPD
state: New Territories
city: Kwai Chung
country: Hong Kong
facility: Kwai Chung Hospital
state: New Terrtories
Study officials:
affiliation: The Hong Kong Polytechnic University
name: WT Chien, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chien WT, Bressington D. A randomized controlled clinical trial of a nurse-led structured psychosocial intervention program for people with first-onset mental illness in psychiatric outpatient clinics. Psychiatry Res. 2015 Sep 30;229(1-2):277-86. doi: 10.1016/j.psychres.2015.07.012. Epub 2015 Jul 10.
citation: McCann TV, Lubman DI, Cotton SM, Murphy B, Crisp K, Catania L, Marck C, Gleeson JF. A randomized controlled trial of bibliotherapy for carers of young people with first-episode psychosis. Schizophr Bull. 2013 Nov;39(6):1307-17. doi: 10.1093/schbul/sbs121. Epub 2012 Nov 20.
citation: Chien WT, Lee IY. The schizophrenia care management program for family caregivers of Chinese patients with schizophrenia. Psychiatr Serv. 2010 Mar;61(3):317-20. doi: 10.1176/ps.2010.61.3.317.
citation: Chien WT, Leung SF, Yeung FK, Wong WK. Current approaches to treatments for schizophrenia spectrum disorders, part II: psychosocial interventions and patient-focused perspectives in psychiatric care. Neuropsychiatr Dis Treat. 2013;9:1463-81. doi: 10.2147/NDT.S49263. Epub 2013 Sep 25.
citation: Chien WT, Leung SF, Chu CS. A nurse-led, needs-based psycho-education intervention for Chinese patients with first-onset mental illness. Contemp Nurse. 2012 Feb;40(2):194-209. doi: 10.5172/conu.2012.40.2.194.