Mindfulness-Based Family Psychoeducation Intervention for Early Psychosis

NCT03688009 | Completed

• 1 other identifier: 15604118
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotic Disorder

Keywords

mindfulness-based intervention; family psychoeducation; Chinese family caregivers; early psychosis; mixed methods design

Outcome Measures

Primary Outcomes (1)

• Change from baseline caregiver's general stress level at 6 weeks and at 12 months

  Measured by Zarit Burden Interview (ZBI) (22 items) (Zarit, Reever, Bach-Peterson 1980), assessing caregivers' subjective burden. The total score ranges from 0 (low burden) to 88 (high burden).

  (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion

Secondary Outcomes (9)

• Change from baseline caregiver's caregiving experiences at 6 weeks and at 12 months

  (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion

• Change from baseline caregiver's physical health and mental health at 6 weeks and at 12 months

  (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion

• Change from baseline caregiver's well-being at 6 weeks and at 12 months

  (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion

• Change from baseline caregiver's perceived family functioning at 6 weeks and at 12 months

  (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion

• Change from baseline youth's recovery at 6 weeks and at 12 months

  (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion

Study Arms (2)

Mindfulness-Based Family Psycho-Education (MBFBE)

EXPERIMENTAL

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.

Behavioral: Mindfulness-Based Family Psycho-Education (MBFBE)

Family Psycho-Education (FPE)

ACTIVE COMPARATOR

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.

Behavioral: Family Psycho-Education (FPE)

Interventions

Mindfulness-Based Family Psycho-Education (MBFBE) 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.

Mindfulness-Based Family Psycho-Education (MBFBE)

Family Psycho-Education (FPE) 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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, 852, Hong Kong

Location

Related Publications (3)

• 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.

  PMID: 39391083 DERIVED

• 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.

  PMID: 36673773 DERIVED

• 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.

  PMID: 30915004 DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 27, 2018
• Study Start: January 1, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)