Mindfulness-Based Family Psychoeducation Intervention for Early Psychosis

NCT ID: NCT03688009

Last Updated: 2024-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-12-30

Brief Summary

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A brief Mindfulness-Based Family Psychoeducation programme is developed to reduce the caregiver's stress and to promote young people's recovery.

A randomized controlled trial will be conducted to compare a mindfulness-based family psychoeducation intervention, with an ordinary family psychoeducation intervention. 300 caregivers of a youth who have experienced early psychosis will be recruited.

Programme effectiveness will be assessed by comparing outcomes measuring caregiver's perceived stress, positive well-being, and the young people's mental health symptoms. As part of the programme activity, Photovoice approach is selected to explore the complex family experiences and the benefits of mindfulness from the caregiver's personal perspectives. Caregivers can offer their voices about their burdens, and how mindfulness can benefit to the families through their involvement in a photo taking activity during the psychoeducation programme.

Detailed Description

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According to the World Health Organization Global Burden of Disease Study, for youth aged 10 to 24 years old, schizophrenia ranked as the third among all causes of disability. Schizophrenia shows a marked increase in prevalence after aged 15 and many manifests in early 20s. The term early psychosis is used for young people before and after their first identified psychotic episode.

The support of family members during the treatment and recovery of early psychosis is critical. Schizophrenia results in serious functional impairment, including a delimited social networks, termination or suspension of schooling. Caregivers encounter much psychological distress, particularly in handling the violent behaviours, suicidal ideation, failures in treatment, and other illness behaviours of such students. One-third of such caregivers have experienced emotional difficulties, such as depression. Family psychoeducation intervention has been recommended as a major component in the treatment of early psychosis.

International and local studies have reported positive outcomes using family psychoeducation interventions, but many limitations have also been identified. Many previous studies implemented an intensive programme design, with an emphasis on improvements in illness outcome of patients only. A recent review concluded that benefits of such programmes to caregivers were limited. There have been calls for a time-limited but more cost-effective programme for caregivers of a youth with early psychosis to mitigate the looming realities of eventual serious mental illness and family suffering. A brief Mindfulness-Based Family Psychoeducation programme is developed to reduce the caregiver's stress and to promote young people's recovery. Results from the pilot study suggested that such programme could reduce caregiver stress, and promote positive caregiving experience.

A more rigorous study is proposed using a mixed methods design. A randomized controlled trial will be conducted to compare a mindfulness-based family psychoeducation intervention, with an ordinary family psychoeducation intervention. 300 caregivers of a youth who have experienced early psychosis will be recruited, with the assistance of five NGO collaborators. Programme effectiveness will be assessed by comparing outcomes measuring caregiver's perceived stress, positive well-being, and the young people's mental health symptoms. As part of the programme activity, Photovoice approach is selected to explore the complex family experiences and the benefits of mindfulness from the caregiver's personal perspectives. Caregivers can offer their voices about their burdens, and how mindfulness can benefit to the families through their involvement in a photo taking activity during the psychoeducation programme.

Conditions

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Psychotic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Mindfulness-Based Family Psycho-Education (MBFBE)

A programme focuses on non-judgmental attitudes, collaborative inquiry and self-care, including components of understanding early psychosis, medication, treatment management, mental health service collaboration, attention to caregiver's experiences and distress, strategies for improving communication and problem-solving, and crisis planning.

Group Type EXPERIMENTAL

Mindfulness-Based Family Psycho-Education (MBFBE)

Intervention Type BEHAVIORAL

Six sessions includes: 1. Working with Caregiving Stress; 2. The Struggles of a Caregiver; 3. The Struggles of a Person in Recovery; 4. The Path of Recovery; 5. A Supportive Caregiving; and 6. Review of Learning.

Family Psycho-Education (FPE)

A programme focuses on information giving, problem-solving and mutual support, including components of understanding early psychosis, medication, treatment management, mental health service collaboration, attention to caregiver's experiences and distress, strategies for improving communication and problem-solving, and crisis planning.

Group Type ACTIVE_COMPARATOR

Family Psycho-Education (FPE)

Intervention Type BEHAVIORAL

Six sessions includes: 1. Working with Caregiving Stress; 2. The Struggles of a Caregiver; 3. The Struggles of a Person in Recovery; 4. The Path of Recovery; 5. A Supportive Caregiving; and 6. Review of Learning.

Interventions

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Mindfulness-Based Family Psycho-Education (MBFBE)

Six sessions includes: 1. Working with Caregiving Stress; 2. The Struggles of a Caregiver; 3. The Struggles of a Person in Recovery; 4. The Path of Recovery; 5. A Supportive Caregiving; and 6. Review of Learning.

Intervention Type BEHAVIORAL

Family Psycho-Education (FPE)

Six sessions includes: 1. Working with Caregiving Stress; 2. The Struggles of a Caregiver; 3. The Struggles of a Person in Recovery; 4. The Path of Recovery; 5. A Supportive Caregiving; and 6. Review of Learning.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* caregivers of a youth under the age of 35 and who has experienced EP, or has a diagnosis of SMI, in the last three years
* caregivers who have offered the care to the student for at least one year.

Exclusion Criteria

* caregivers who have diagnoses of SMI or developmental disabilities, such as intellectual disabilities, which may present difficulties in comprehending the content of the programme.
* both caregivers and youth who refuse to receive regular psychiatric consultation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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Zhang ZJ, Lo HHM, Ho WC, Lau ENS, Ng SM, Mak WWS, Wong SYS, Hung KSY, Lai IYS, Lo CSL, Wong JOY, Lui SSY, Siu CMW, Yan EWC, Chan SHW, Lin E, Wong GOC, Mak JWH, Tam HSW, Tse IHH. Mindfulness-based family psychoeducation intervention for caregivers of young adults with first-episode psychosis: results at 9-month follow-up. Front Psychiatry. 2024 Sep 26;15:1460151. doi: 10.3389/fpsyt.2024.1460151. eCollection 2024.

Reference Type DERIVED
PMID: 39391083 (View on PubMed)

Zhang ZJ, Lo HHM, Ng SM, Mak WWS, Wong SYS, Hung KSY, Lo CSL, Wong JOY, Lui SSY, Lin E, Siu CMW, Yan EWC, Chan SHW, Yip A, Poon MF, Wong GOC, Mak JWH, Tam HSW, Tse IHH, Leung BFH. The Effects of a Mindfulness-Based Family Psychoeducation Intervention for the Caregivers of Young Adults with First-Episode Psychosis: A Randomized Controlled Trial. Int J Environ Res Public Health. 2023 Jan 5;20(2):1018. doi: 10.3390/ijerph20021018.

Reference Type DERIVED
PMID: 36673773 (View on PubMed)

Lo HH, Ho WC, Lau EN, Lo CW, Mak WWS, Ng SM, Wong SY, Wong JO, Lui SSY, Lo CS, Lin EC, Poon MF, Choi K, Leung CW. A Brief Mindfulness-Based Family Psychoeducation Intervention for Chinese Young Adults With First Episode Psychosis: A Study Protocol. Front Psychol. 2019 Mar 11;10:516. doi: 10.3389/fpsyg.2019.00516. eCollection 2019.

Reference Type DERIVED
PMID: 30915004 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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15604118

Identifier Type: -

Identifier Source: org_study_id

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