Problem-solving-based Bibliotherapy Program for Family Caregivers

NCT02391649 | Completed DMC

• 1 other identifier: 15401114
• Study Type: interventional
• Target: 422
• Locations: 1 country
• Sites: 2

Brief Summary

This proposed randomized controlled trial will test the effectiveness of a problem-solving based bibliotherapy program (PSBBP) for Chinese family caregivers in psychotic disorders (not more than 5 years onset). A repeated-measures, three-group design will be used to evaluate and compare the effects between two treatment groups(PSBBP and psycho-education group) and routine outpatient service and family support (control group) for 198 randomly selected family caregivers of outpatients with psychotic disorders over a 24-month follow-up. Before the 3-arm trial to be conducted, a pilot parallel-group randomised controlled trial with a similar study design to the later three-arm randomised controlled trial (Phase 2) will be conducted at one psychiatric outpatient clinic in Hong Kong. Receiving an additional funding from local government, another pilot two-arm trial will also be conducted for family caregivers of people with first-episode psychosis in the community to support and inform the 3-arm randomised controlled trial.

Conditions

Schizophrenia; Psychotic Disorders

Keywords

psychosis; self-learning program; problem-solving; family caregivers; randomized controlled trial

Outcome Measures

Primary Outcomes (6)

• Perceived burden of care (Chinese version of the 25-item 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 (for Phases 1 and 2) after completion of intervention

• Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule)

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

  12 months (for Phases 1 and 2) after completion of intervention

• Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule)

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

  24 months (for Phase 2 only) after completion of intervention

• 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.

  6 months (for Phases 1 and 2) after completion of intervention

• 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.

  12 months (for Phases 1 and 2) after completion of intervention

• 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.

  24 months (for Phase 2 only) after completion of intervention

Secondary Outcomes (6)

• Experience of caregiving (Chinese version of Experience of Caregiving Inventory)

  24 months (Phase 2; 6 and 12 months for Phase 1) after completion of intervention

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

  24 months (Phase 2; 6 and 12 months for Phase 1) after completion of intervention

• Mental state (Positive and Negative Syndrome Scale)

  24 months (Phase 2; 6 and 12 months for Phase 1) after completion of intervention

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

  24 months (Phase 2; 6 and 12 months for Phase 1) after completion of intervention

• Perceived expressed emotion (Level of Expressed Emotion scale; used in Phase 2 only)

  24 months after completion of intervention

Study Arms (3)

Self-learning program

EXPERIMENTAL

The participants in the Problem-solving Based Self-learning Program will complete the self-help and problem-solving manual developed by the research team for caregivers of people with psychotic disorders over 20 weeks. In addition to the orientation, understanding about psychosis and its care and final review sessions (4 sessions in 3 weeks) facilitated by the research nurse, the caregivers will work independently through the modules over 15-17 weeks.

Behavioral: Self-learning program

Psycho-education (in Phase 2)

ACTIVE COMPARATOR

Two trained advanced practice psychiatric nurses who are experienced in psychiatric rehabilitation and group programs will lead the psychoeducation group, which is guided by a validated treatment protocol based on the research team's and McFarlane and his colleagues' psychoeducation programs for psychosis. The program consists of 12 two-hour sessions held weekly/biweekly (similar to the self-learning program, completed in 5 months), with 4 main components, including 'introduction and goal setting'; 'an education workshop on mental illness, treatment and community services'; 'group exercises/rehearsals and discussion on symptom management, coping and self-care'; and ''review and future plan'.

Behavioral: Psycho-education program (in Phase 2)

Routine community care

NO INTERVENTION

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

Interventions

Self-learning program BEHAVIORAL

The PSBBP in this study 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), helping each caregiver from developing a positive attitude to caregiving, identifying caring related problems and obstacles, predicting positive and negative implications of each alternative, to trying out the solution and monitor if it worked.

Self-learning program

Psycho-education program (in Phase 2) BEHAVIORAL

The program consists of 12 two-hour sessions held weekly/biweekly completed in 5 months, with 4 main components, including 'introduction and goal setting'; 'an education workshop on mental illness, treatment and community services'; 'group exercises/rehearsals and discussion on symptom management, coping and self-care'; and 'review and future plan'.

Psycho-education (in Phase 2)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Hong Kong Chinese residents, aged 18-60;
• taking care of and living with a family member primarily diagnosed with one psychotic disorder in the past 5 years (for Phase 1, patients with recent-onset \[12 months\] or first-episode 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)

You may not qualify if:

• those received or are receiving another family intervention;
• those are having cognitive impairment or learning disability; and/or
• those 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Castle Peak Hospital: collaborator
• Prince of Wales Hospital, Shatin, Hong Kong: collaborator
• University of Victoria: collaborator

Study Sites (2)

Li Ka Shing Specialty OPD

Shatin, NT, Hong Kong

Location

TM Psy Centre

Tuenmen, NT, Hong Kong

Location

Related Publications (6)

• Chien WT, Chan SW. Testing the psychometric properties of a Chinese version of the Level of Expressed Emotion scale. Res Nurs Health. 2009 Feb;32(1):59-70. doi: 10.1002/nur.20303.

  PMID: 18800379 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

• Breitborde NJ, Moreno FA, Mai-Dixon N, Peterson R, Durst L, Bernstein B, Byreddy S, McFarlane WR. Multifamily group psychoeducation and cognitive remediation for first-episode psychosis: a randomized controlled trial. BMC Psychiatry. 2011 Jan 12;11:9. doi: 10.1186/1471-244X-11-9.

  PMID: 21226941 BACKGROUND

• Chien WT, Yip AL, Liu JY, McMaster TW. The effectiveness of manual-guided, problem-solving-based self-learning programme for family caregivers of people with recent-onset psychosis: A randomised controlled trial with 6-month follow-up. Int J Nurs Stud. 2016 Jul;59:141-55. doi: 10.1016/j.ijnurstu.2016.03.018. Epub 2016 Apr 6.

  PMID: 27222459 RESULT

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Wai Tong CHIEN

  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, three-arm design (and in phase 1, two pilot 2-arm controlled trials with repeated-measures design; sample size 112 for the two pilot studies)

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: March 18, 2015
• Study Start: March 1, 2014
• Primary Completion: August 31, 2019
• Study Completion: August 30, 2020
• Last Updated: September 14, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)