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Schizophrenia Spectrum DisordersPSBPFNCT02283437

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

A study testing Problem-solving Based Bibliotherapy Program and Behavioral Management and Education Program in people with Schizophrenia Spectrum Disorders and Family Caregivers, run by Chinese University of Hong Kong 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

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. Read more about this study

Who is it for?
Ages 18 to 64 years
What is being tested?
Problem-solving Based Bibliotherapy Program and Behavioral Management and Education Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
2 sitesHong Kong
Study dates
1 Apr 2018to 30 Apr 2020
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

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Hong Kong2 sites

  • KH OPD

    Mong Kok, Kowloon

  • Li Ka Shing Specialty OPD

    Shatin, NT

Other trials in Hong Kong

About this study

Official title: A Randomized Controlled Trial of Problem-solving Based Bibliotherapy Program for Family Caregivers of People With Schizophrenia Spectrum Disorders

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.

Read the detailed description

Family caregivers of people with schizophrenia-spectrum disorders are confronted by a various physical, psychosocial and financial hardships. This can adversely affect family members' caregiving experiences, psychological distress, general well-being, and family relationships or emotional involvement, which in turn may contribute to a greater risk of patient relapse and non-recovery. While family psycho-education (behavioral management) and mutual support groups are effective in reducing caregivers' burden of care, these approaches usually require regular meetings and encounter difficulties in extensive training of group leaders/facilitators and engaging participants to actively share their caregiving experiences due to time inconvenience and fear/inability of expression of feelings. By virtue of the above, an alternate model of self-help program in book form named bibliotherapy, which is a guided reading and self-practice program with problem-solving training facilitated by a psychiatric nurse, has recently demonstrated evidences in clinical trials for families of depressive and psychotic patients by the research team, and other researchers.

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 and educational group) and routine outpatient service and family support(control group) for 150 randomly selected family caregivers of outpatients with schizophrenia-spectrum disorders over a 18-month follow-up. Primary outcomes include caregivers' burden of care, caregiving experiences and coping and social problem-solving skills using validated instruments. Secondary outcomes are patients' mental state, functioning, perceived expressed emotion, and re-hospitalization rate. They will be measured at recruitment, one week, and 6 and 18 months following the interventions. Kaplan-Meier survival analysis will be used to analyze the relative risks of re-hospitalizations amongst the treatment and control groups over 18-month follow-up. It is hypothesized that the PSBPF participants will produce significantly better improvements in caregivers' perceived burden, caregiving experience and coping and problem-solving skills than those in behavioral management/education and control groups over 18-month follow-up.

Focus group interviews will be conducted after the first post-test with 30 caregivers (15 participants per group) in both treatment groups. Their data will be content analyzed to identify their perceived benefits, limitations and difficulties encountered and therapeutic ingredients of the two programs. With significant positive outcomes found in the PSBPF, this program will be adopted by community mental healthcare services in Hong Kong, and replicated in other Asian countries, to improve family-based care in schizophrenia-spectrum disorders.

Study Objectives:

This controlled trial tests the effects of the PSBPF on family caregivers' and patients' outcomes over a 18-month follow-up, when compared with those in a behavioral management and education group or routine family services for outpatients. Primary outcomes include caregivers' burden of care, coping and problem-solving skills. It will test two hypotheses that, comparing with those in behavioral management and education/routine care, the PSBPF will indicate significantly:

  • greater reduction of caregivers' perceived burden and improvements in coping and social problem-solving skills and caregiving experiences at 1-week, 6-month and/or 18-month follow-ups; and
  • greater improvements in patients' mental state, psychosocial functioning, perceived expressed emotion, and re-hospitalization rate at the three follow-ups.
Being tested
Problem-solving Based Bibliotherapy Program, Behavioral Management and Education Program
Keywords
Bibliotherapy, Problem-solving, Randomized Controlled Trial, Schizophrenia Spectrum Disorders, Family Caregivers

What participants receive

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

  • Problem-solving Based Bibliotherapy ProgramBehavioural

    Also called PSBPF

    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.

  • Behavioral Management and Education ProgramBehavioural

    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.

Study groups in NCT02283437
Study groupRoleWhat they receive
Problem-solving Based BibliotherapyExperimentalThe 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).
Receives: Behavioral: Problem-solving Based Bibliotherapy Program
Behavioral Management and Education ProgramActive comparatorThe 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.
Receives: Behavioral: Behavioral Management and Education Program
Routine Outpatient ServiceNo interventionParticipants in the control group (and 2 treatment groups) will receive routine psychiatric outpatient and family services.

What is being measured

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

  1. 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.

    Measured: 18 months after completion of intervention

  2. 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.

    Measured: 18 months follow-up

  3. 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.[

    Measured: 18 months follow-up

Secondary outcomes (5)

  1. Experience of Caregiving

    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. It consists of 10 subscales measuring negative (e.g., difficult behaviors, stigma and problems with services) and positive aspects (positive personal experience and aspects of relationship) of caregiving, being rated on a 5-point Likert scale ('0-never' to '4-nearly always'). It indicates satisfactory content validity and internal consistency (Cronbach's alpha= 0.60-0.85); higher scores on negative/positive (reverse-coded) subscale indicate a more negative appraisals.

    Measured: 18 months follow-up

  2. Mental State

    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. Each item is scored on a scale, ranging from '1- absent' to '7- extreme', and the scale has demonstrated good inter-rater reliability (Intra-class correlation= 0.88) and good internal consistency (Cronbach's alpha= 0.87-0.93), and concurrent and predictive validity.

    Measured: 18 months follow-up

  3. Patient Functioning

    The 43-item Specific Level of Functioning Scale will be used to assess 3 functional domains for patients with schizophrenia, including physical functioning/personal care (12 items), social functioning (14 items) and community living skills (17 items) on a 5-point Likert scale. The Chinese version was validated among patients with schizophrenia in Hong Kong, indicating satisfactory content validity, test-retest reliability (Pearson's r=0.76) and internal consistency (Cronbach's alpha= 0.88-0.96).

    Measured: 18 months follow-up

  4. Perceived Expressed Emotion

    Perceived expressed emotion by patients will be measured by Level of Expressed Emotion scale. The scale comprises 4 domains: intrusiveness, attitude toward illness, tolerance/expectancy, and emotional responses; each consists of 15 items on a 4-point Likert scale ('1-Not true' to '4-True'). The Chinese version has indicated satisfactory internal consistency (Cronbach's alpha= 0.80-0.90) and test-retest reliability (r= 0.87-0.93)

    Measured: 18 months follow-up

  5. Rate & Length of Rehospitalizations

    The data of patients' frequency and lengths (days) of psychiatric hospitalizations over the intervention period, and 12-month follow-ups, will be recorded by the research assistant by reviewing the electronic patient record (ePR) at outpatient clinics.

    Measured: 18 months follow-up

Timeline

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

  1. First posted5 Nov 2014 (estimated)
  2. Study start1 Apr 2018
  3. Primary completion31 Dec 2019
  4. Study completion30 Apr 2020

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, three-arm design
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02283437
Sponsor's protocol ID
HSEARS2014218003
Acronym
PSBPF
Status last verified
Sep 2020
First submitted
3 Nov 2014
Last updated
9 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19679716

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Problem-solving Based Bibliotherapy Program and Behavioral Management and Education Program in people with Schizophrenia Spectrum Disorders and Family Caregivers, run by Chinese University of Hong Kong 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 2 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 9 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 (time frame: 18 months after completion of intervention). 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 NCT02283437, which also lists 2 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 9 Sep 2020.

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