A Problem-solving Based Bibliotherapy Program for Family Caregivers in Schizophrenia

NCT02283437 | Completed

• 1 other identifier: HSEARS2014218003
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief Summary

This proposed randomized controlled trial will test the effectiveness of a problem-solving based bibliotherapy program (PSBPF) for Chinese family caregivers in schizophrenia spectrum disorders. A repeated-measures, three-group design will be used to evaluate and compare the effects between two treatment groups (PSBPF and behavioral management group) and routine outpatient service (control group) for 150 randomly selected family caregivers of outpatients with schizophrenia-spectrum disorders over a 18-month follow-up.

Conditions

Schizophrenia Spectrum Disorders; Family Caregivers

Keywords

Bibliotherapy; Problem-solving; Randomized Controlled Trial; Schizophrenia Spectrum Disorders; Family Caregivers

Outcome Measures

Primary Outcomes (3)

• Perceived Burden of Care

  Caregivers' perceived burden of care will be measured by a Chinese version of the 25-item Family Burden Interview Schedule. It assesses the caring burden perceived by family members in taking care of the patient at home. It is comprised of six categories (2-6 items per category), including familial finance, routine, leisure activities, interactions, and physical and mental health. Total scores range from 0-50; a higher score will indicate a greater caring burden. The Chinese version of the scale indicated satisfactory internal consistency (Cronbach's alpha= 0.87) and high inter-rater reliability (Pearson's r= 0.75-0.99) in families of schizophrenia sufferers in Hong Kong.

  18 months after completion of intervention

• Coping Style

  A Chinese version of Coping style of the caregivers style will be assessed using the 42-item Revised Ways of Coping Checklist. It composes of a problem-focused coping(15 items) and three emotion-focused coping scales, including 'self-blame' (3 items), 'wishful thinking'(8 items) and 'avoidance'(10 items), and a subscale 'seeking social support'(6 items). Items are scored on a 5-point Likert scale, from '0-never' to '4-all the time', higher scores indicating greater uses of those coping strategies. It has demonstrated satisfactory internal consistency (Cronbach's alpha= 0.62-0.85) in students.

  18 months follow-up

• Social Problem-Solving Inventory

  The Chinese version of Revised (Short) Social Problem-Solving Inventory. It contains 25 items, assessing 2 domains of social problem-solving, including problem-solving style(3 subscales- rational problem solving, impulsive/careless style and avoidance style), and problem-solving orientation (2 subscales- positive and negative problem orientation). It has demonstrated satisfactory internal consistency (Cronbach's alpha= 0.68-0.81) and concurrent validity with a few coping scales in Hong Kong adolescents.\[

  18 months follow-up

Secondary Outcomes (5)

• Experience of Caregiving

  18 months follow-up

• Mental State

  18 months follow-up

• Patient Functioning

  18 months follow-up

• Perceived Expressed Emotion

  18 months follow-up

• Rate & Length of Rehospitalizations

  18 months follow-up

Study Arms (3)

Problem-solving Based Bibliotherapy

EXPERIMENTAL

The Problem-solving Based Bibliotherapy Program (PSBPF) using a self-help manual based on problem-solving therapy defined by D'Zurilla and Nezu (2007) to be 'a self-directed cognitive-behavioral process by which a person attempts to identify/discover effective/adaptive solutions for specific problems encountered in everyday living' (p.11).

Behavioral: Problem-solving Based Bibliotherapy Program

Behavioral Management and Education Program

ACTIVE COMPARATOR

The Behavioral Management and Education group program will be guided by a validated treatment protocol based on the research team's (Chien and Wong, 2007) psycho-education and McFarlane et al.'s (2003) family behavioral management programs for schizophrenia.

Behavioral: Behavioral Management and Education Program

Routine Outpatient Service

NO INTERVENTION

Participants in the control group (and 2 treatment groups) will receive routine psychiatric outpatient and family services.

Interventions

Problem-solving Based Bibliotherapy Program BEHAVIORAL

The PSBPF will complete the bibliotherapy (self-help) and problem-solving manual developed by the research team for caregivers of people with schizophrenia spectrum disorders.

Also known as: PSBPF

Problem-solving Based Bibliotherapy

Behavioral Management and Education Program BEHAVIORAL

Two trained advanced practice psychiatric nurses who are experienced in psychiatric rehabilitation and group programs will lead the behavioral management and education group, which is guided by a validated treatment protocol based on the research team's (Chien and Wong, 2007) and McFarlane et al.'s (2001) family management programs for schizophrenia.

Behavioral Management and Education Program

Eligibility Criteria

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

You may qualify if:

• Hong Kong Chinese residents, aged 18-64;
• Taking care of a family member primarily diagnosed as schizophrenia spectrum disorders, including schizophrenia, schizophreniform and schizoaffective disorders, as stated in the criteria of the Diagnostic and Statistical Manual (DSM-IV Text-Revised edition) in the past 3 years;
• 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 for case selection).

You may not qualify if:

• Caregivers have received or are receiving another family intervention; or
• Presented with a recent personal history of a serious mental illness/medical disease and/or learning difficulties.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Integrated Community Care and Family Support Centres: collaborator

Study Sites (2)

KH OPD

Mong Kok, Kowloon, Hong Kong

Location

Li Ka Shing Specialty OPD

Shatin, NT, Hong Kong

Location

Related Publications (2)

• McCann TV, Lubman DI, Clark E. First-time primary caregivers' experience of caring for young adults with first-episode psychosis. Schizophr Bull. 2011 Mar;37(2):381-8. doi: 10.1093/schbul/sbp085. Epub 2009 Aug 13.

  PMID: 19679716 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

Study Officials

• Wai Tong 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 received by the participants
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Repeated-measures, three-arm design

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 5, 2014
• Study Start: April 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: April 30, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)