Nurse-led Psycho-education Program for People With First-onset Mental Illness (APN-PEP)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-01

Study Completion Date

2016-08-31

Brief Summary

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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.)

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Detailed Description

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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.

Conditions

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Mental Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Repeated measures, two-arm design

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

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Outcome assessors are blind to the group assignment and intervention undertaken and concealed to the participant list.

Study Groups

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Nurse-led Psycho-education [SPBB: Self-learning program]

The Nurse-led Psychoeducation Program is comprised of eight 2-hour sessions held at every two weeks (over 4 months). The program consists of five themes: (a) orientation and engaging and understanding of mental health/illness, its related behaviors and community support resources; (b) working collaboratively and empowering and minimizing resistance and challenges using motivational interviewing approach; (c) effective interpersonal and communication skills; (d) strategies in coping with mental illness, sleep hygiene and allaying anxiety; and (e) self-review and evaluation and establishing a realistic plan for future.

\[Note: The participants in the SPBB will complete the self-help and problem-solving manual (5 modules) for caregivers of people with psychotic disorders over 20 weeks, together with an orientation, understanding about psychosis and its care and 4 review sessions.\]

Group Type EXPERIMENTAL

Nurse-led Psycho-education (or SPBB: self-learning program)

Intervention Type BEHAVIORAL

The program was modified from the psycho-educational, motivation-driven and emotionally supportive programs developed and previously tested by the research team in Chinese people with different kinds of serious mental illness, mainly including schizophrenia spectrum disorders and mood disorders by Chien and his colleagues in 2012, and adherence therapy for people with psychotic disorders by Gray et al. (2010).

\[Note: SPBB consists of 5 modules (Module 1: Caregiver's well-being; Module 2:Getting the best out of support services; Module 3:Well-being of the person with schizophrenia; Module 4:Dealing with the \[psychosocial\] effects of the illness; and Module 5: Dealing with \[physical and mental health\] effects of the illness).\]

Usual Psychiatric Outpatient Care

Intervention Type BEHAVIORAL

These services consisted of medical consultation and treatment by the attending psychiatrist (i.e., around every four weeks), brief education sessions (i.e., 3 or 4 one-hour sessions) on mental illness and treatment received by psychiatric nurses, and advices and referrals for community mental health and social welfare services available and/or family counseling by a psychiatric nurse or medical social worker in each clinic.

Usual Psychiatric Outpatient Care

Routine psychiatric outpatient care provided by two psychiatric outpatient clinics under study

\[Note: for SPBB trial, routine psychiatric outpatient care provided by two psychiatric outpatient clinics under study\]

Group Type ACTIVE_COMPARATOR

Usual Psychiatric Outpatient Care

Intervention Type BEHAVIORAL

These services consisted of medical consultation and treatment by the attending psychiatrist (i.e., around every four weeks), brief education sessions (i.e., 3 or 4 one-hour sessions) on mental illness and treatment received by psychiatric nurses, and advices and referrals for community mental health and social welfare services available and/or family counseling by a psychiatric nurse or medical social worker in each clinic.

Interventions

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Nurse-led Psycho-education (or SPBB: self-learning program)

The program was modified from the psycho-educational, motivation-driven and emotionally supportive programs developed and previously tested by the research team in Chinese people with different kinds of serious mental illness, mainly including schizophrenia spectrum disorders and mood disorders by Chien and his colleagues in 2012, and adherence therapy for people with psychotic disorders by Gray et al. (2010).

\[Note: SPBB consists of 5 modules (Module 1: Caregiver's well-being; Module 2:Getting the best out of support services; Module 3:Well-being of the person with schizophrenia; Module 4:Dealing with the \[psychosocial\] effects of the illness; and Module 5: Dealing with \[physical and mental health\] effects of the illness).\]

Intervention Type BEHAVIORAL

Usual Psychiatric Outpatient Care

These services consisted of medical consultation and treatment by the attending psychiatrist (i.e., around every four weeks), brief education sessions (i.e., 3 or 4 one-hour sessions) on mental illness and treatment received by psychiatric nurses, and advices and referrals for community mental health and social welfare services available and/or family counseling by a psychiatric nurse or medical social worker in each clinic.

Intervention Type BEHAVIORAL

Other Intervention Names

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APN-PEP UPOC

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No