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

NCT02275390 | Completed DMC

• 1 other identifier: 2012100368
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

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.)

Conditions

Mental Illness

Keywords

psychosis; self-learning; problem solving; randomized controlled trial; family carer; recent-onset psychosis

Outcome Measures

Primary Outcomes (3)

• 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.

  6 months after completion of intervention [SPBB study only]

• 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.

  6 months after completion of intervention [SPBB study only]

• 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.

  12 months after completion of intervention

Secondary Outcomes (8)

• Coping style (42-item Revised Ways of Coping Checklist)

  6 months after completion of intervention [SPBB only]

• Social Problem-Solving (Chinese version of Revised (Short) Social Problem-Solving

  6 months after completion of intervention [SPBB only]

• Mental state (Positive and Negative Syndrome Scale)

  6 months after completion of intervention [SPBB only]

• Hospitalization and Default Follow-up Rate

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

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

  6 months after completion of intervention [SPBB only]

Study Arms (2)

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

EXPERIMENTAL

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

Behavioral: Nurse-led Psycho-education (or SPBB: self-learning program); Behavioral: Usual Psychiatric Outpatient Care

Usual Psychiatric Outpatient Care

ACTIVE COMPARATOR

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

Behavioral: Usual Psychiatric Outpatient Care

Interventions

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

Also known as: APN-PEP

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

Usual Psychiatric Outpatient Care 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.

Also known as: UPOC

Nurse-led Psycho-education [SPBB: Self-learning program]; Usual Psychiatric Outpatient Care

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• United Christian Hospital: collaborator

Study Sites (2)

United Christian Psychiatric OPD

Tai Po, New Territories, Hong Kong

Location

Kwai Chung Hospital

Kwai Chung, New Terrtories, Hong Kong

Location

Related Publications (5)

• 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.

  PMID: 26193827 BACKGROUND

• 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.

  PMID: 23172001 BACKGROUND

• 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.

  PMID: 20194413 BACKGROUND

• 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.

  PMID: 24109184 BACKGROUND

• 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.

  PMID: 22554213 BACKGROUND

MeSH Terms

Conditions

Mental Disorders; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• WT Chien, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are blind to the group assignment and intervention undertaken and concealed to the participant list.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: October 27, 2014
• Study Start: March 1, 2012
• Primary Completion: May 31, 2016
• Study Completion: August 1, 2016
• Last Updated: September 25, 2020

Record last verified: 2020-09

Locations

HK (2)