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Mental IllnessAPN-PEPNCT02275390

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

A study testing Nurse-led Psycho-education (or SPBB: self-learning program) and Usual Psychiatric Outpatient Care in people with Mental Illness, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Mental Illness
What is being tested?
Nurse-led Psycho-education (or SPBB: self-learning program) and Usual Psychiatric Outpatient Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
2 sitesHong Kong
Study dates
1 Mar 2012to Aug 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.]

Trial locations and contacts

2 sites in 1 country.

Hong Kong2 sites

  • Kwai Chung Hospital

    Kwai Chung, New Terrtories

  • United Christian Psychiatric OPD

    Tai Po, New Territories

Other trials in Hong Kong

About this study

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)

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.)

Read the 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.

Conditions
Mental Illness
Being tested
Nurse-led Psycho-education (or SPBB: self-learning program), Usual Psychiatric Outpatient Care
Keywords
psychosis, self-learning, problem solving, randomized controlled trial, family carer, recent-onset psychosis
Medical subject headings
Mental Disorders, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called APN-PEP

    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 CareBehavioural

    Also called UPOC

    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.

Study groups in NCT02275390
Study groupRoleWhat they receive
Nurse-led Psycho-education [SPBB: Self-learning program]ExperimentalThe 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.]
Receives: Behavioral: Nurse-led Psycho-education (or SPBB: self-learning program); Behavioral: Usual Psychiatric Outpatient Care
Usual Psychiatric Outpatient CareActive comparatorRoutine 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]
Receives: Behavioral: Usual Psychiatric Outpatient Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perceived burden of care (Chinese version of Family Burden Interview Schedule)

    Caregivers' perceived burden of care will be measured by a Chinese version of the 25-item Family Burden Interview Schedule.

    Measured: 6 months after completion of intervention [SPBB study only]

  2. Experience of caregiving (Chinese version of Experience of Caregiving Inventory)

    The Chinese version of Experience of Caregiving Inventory is a 66-item self-reporting scale that measures experiences of caregiving to a family member with mental illness based on the transactional model of stress-appraisal-coping.

    Measured: 6 months after completion of intervention [SPBB study only]

  3. Brief Psychiatric Rating Scale

    The participants' mental status is assessed and rated on a 7-point Likert scale for each item of the 18-item Brief Psychiatric Rating Scale.

    Measured: 12 months after completion of intervention

Secondary outcomes (8)

  1. Coping style (42-item Revised Ways of Coping Checklist)

    A Chinese version of Coping style of the caregivers style will be assessed using the 42-item Revised Ways of Coping Checklist.

    Measured: 6 months after completion of intervention [SPBB only]

  2. Social Problem-Solving (Chinese version of Revised (Short) Social Problem-Solving

    The Chinese version of Revised (Short) Social Problem-Solving Inventory will be used to assess participants' problem solving.

    Measured: 6 months after completion of intervention [SPBB only]

  3. Mental state (Positive and Negative Syndrome Scale)

    Patients' mental state will be evaluated by the Positive and Negative Syndrome Scale, a 30-item inventory assessing the absence/severity of psychotic symptoms across positive symptoms, negative symptoms and general psycho-pathology symptoms.

    Measured: 6 months after completion of intervention [SPBB only]

  4. Hospitalization and Default Follow-up Rate

    Frequency and length of hospitalizations and outpatient clinic default follow-up rates of participants during intervention and 6 months after interventions would be calculated.

    Measured: 12 months after completion of intervention [6 months in SPBB study]

  5. Patient functioning (43-item Specific Level of Functioning Scale)

    The 43-item Specific Level of Functioning Scale will be used to assess 3 functional domains for patients with schizophrenia spectrum disorders, including physical functioning/personal care (12 items), social functioning (14 items) and community living skills (17 items) on a 5-point Likert scale.

    Measured: 6 months after completion of intervention [SPBB only]

  6. Insight and Treatment Attitudes Questionnaire (APN-PEP)

    The 11-item Insight and Treatment Attitudes Questionnaire was designed to measure patients' awareness of illness and insight into their needs for treatment for schizophrenia (McEvoy et al., 1989). Its items are rated on a 3-point scale (0=no insight; 1=partial insight; 2=good insight). The higher the score, the better is the patient's awareness of and insight into mental health problems, possibility of future illness, and willingness to receive treatments.

    Measured: 12 months after completion of intervention

  7. World Health Organisation Quality of Life Measure - Brief Version

    The 28-item Chinese version of quality of life scale was modified from the World Health Organization Quality of Life 100-item [WHOQoL-100] questionnaire by the World Health Organization in 1995 and translated and validated by Leung, Tay, Cheng, and Lin (1997). Items are structured in four domains, including physical health, psychological, social relationship, and environment (i.e., 7 items for each subscale). They are rated on a 5-point Likert scale with a high score indicating a better quality of life (total score range 28-140).

    Measured: 12 months after completion of intervention

  8. Perceived Self-efficacy Scale

    The 10-item Perceived Self-efficacy Scale developed by Jerusalem and Schwarzer in 1992 was translated into Chinese by Zhang and Schwarzer (1995). It is a unidimensional, generic measure of one's competence in the management of challenging and stressful encounters in life situations. ). The items are rated on a 4-point Likert scale (1=absolutely correct to 4=absolutely incorrect), with a total score ranging from 10-40.

    Measured: 12 months after completion of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2014 (estimated)
  2. Study start1 Mar 2012
  3. Primary completion31 May 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Repeated measures, two-arm design \[SPBB: A repeated-measures, two-arm design with 112 outpatients and their family caregivers\]
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02275390
Sponsor's protocol ID
2012100368
Acronym
APN-PEP
Status last verified
Sep 2020
First submitted
23 Oct 2014
Last updated
25 Sep 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26193827

  • 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.

    PubMed 23172001

  • 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.

    PubMed 20194413

  • 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.

    PubMed 24109184

  • 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.

    PubMed 22554213

Questions about this trial

What is this clinical trial studying?

A study testing Nurse-led Psycho-education (or SPBB: self-learning program) and Usual Psychiatric Outpatient Care in people with Mental Illness, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived burden of care (Chinese version of Family Burden Interview Schedule) (time frame: 6 months after completion of intervention [SPBB study only]). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02275390, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.

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