Clinical trial NCT03688009: Mindfulness-Based Family Psychoeducation Intervention for Early Psychosis
Official title: Brief Mindfulness-Based Family Psychoeducation Intervention for Chinese Students With Early Psychosis: A Mixed Methods Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotic Disorder
Keywords: mindfulness-based intervention
family psychoeducation
Chinese family caregivers
early psychosis
mixed methods design
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline caregiver's general stress level at 6 weeks and at 12 months
timeFrame: (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion
Secondary outcomes:
measure: Change from baseline caregiver's caregiving experiences at 6 weeks and at 12 months
timeFrame: (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion
measure: Change from baseline caregiver's physical health and mental health at 6 weeks and at 12 months
timeFrame: (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion
measure: Change from baseline caregiver's well-being at 6 weeks and at 12 months
timeFrame: (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion
measure: Change from baseline caregiver's perceived family functioning at 6 weeks and at 12 months
timeFrame: (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion
measure: Change from baseline youth's recovery at 6 weeks and at 12 months
timeFrame: (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion
measure: Change from baseline caregiver's interpersonal mindfulness at 6 weeks and at 12 months
timeFrame: (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion
measure: Change from baseline caregiver's non-attachment at 6 weeks and at 12 months
timeFrame: (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion
measure: Change from baseline youth's expressed emotion at 6 weeks and at 12 months
timeFrame: (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion
measure: Change from baseline youth's psychiatric symptom at 6 weeks and at 12 months
timeFrame: (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
References:
citation: 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.