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Trial record 4 of 20451 for:    mental illness

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02275390
First Posted: October 27, 2014
Last Update Posted: August 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
United Christian Hospital
Information provided by (Responsible Party):
Chien Wai-Tong, The Hong Kong Polytechnic University
  Purpose
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.

Condition Intervention Phase
Mental Illness Behavioral: Nurse-led Psycho-education Behavioral: Usual Psychiatric Outpatient Care Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
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

Resource links provided by NLM:


Further study details as provided by Chien Wai-Tong, The Hong Kong Polytechnic University:

Primary Outcome Measures:
  • Brief Psychiatric Rating Scale [ Time Frame: 12 months after completion of intervention ]
    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.


Secondary Outcome Measures:
  • Insight and Treatment Attitudes Questionnaire [ Time Frame: 12 months after completion of intervention ]
    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.

  • Perceived Self-efficacy Scale [ Time Frame: 12 months after completion of intervention ]
    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.

  • World Health Organisation Quality of Life Measure - Brief Version [ Time Frame: 12 months after completion of intervention ]
    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).

  • Hospitalization and Default Follow-up Rate [ Time Frame: 12 months after completion of intervention ]
    Frequency and length of hospitalizations and outpatient clinic default follow-up rates of participants during intervention and 12 months after interventions would be calculated.


Enrollment: 180
Study Start Date: May 2012
Study Completion Date: August 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nurse-led Psycho-education Program
The Nurse-led Psychoeducation Program is comprised of eight 2-hour sessions held at every two weeks (i.e., over four 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.
Behavioral: Nurse-led Psycho-education
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).
Other Name: APN-PEP
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.
Other Name: TAU
Active Comparator: Usual Psychiatric Outpatient Care
Routine psychiatric outpatient care provided by two psychiatric outpatient clinics under study
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.
Other Name: TAU

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02275390


Locations
Hong Kong
Kwai Chung Hospital
Kwai Chung, NT, Hong Kong
AHNH Psychiatric OPD
Taipo, NT, Hong Kong
Sponsors and Collaborators
The Hong Kong Polytechnic University
United Christian Hospital
Investigators
Principal Investigator: WT Chien, PhD The Hong Kong Polytechnic University
  More Information