Psychotic DisorderNCT03688009
Mindfulness-Based Family Psychoeducation Intervention for Early Psychosis
A study testing Mindfulness-Based Family Psycho-Education (MBFBE) and Family Psycho-Education (FPE) in people with Psychotic Disorder, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychotic Disorder
- What is being tested?
- Mindfulness-Based Family Psycho-Education (MBFBE) and Family Psycho-Education (FPE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2019to 30 Dec 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brief Mindfulness-Based Family Psychoeducation Intervention for Chinese Students With Early Psychosis: A Mixed Methods Study
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.
Read the 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.
- Conditions
- Psychotic Disorder
- Being tested
- Mindfulness-Based Family Psycho-Education (MBFBE), Family Psycho-Education (FPE)
- Keywords
- mindfulness-based intervention, family psychoeducation, Chinese family caregivers, early psychosis, mixed methods design
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Family Psycho-Education (MBFBE)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Family Psycho-Education (FPE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: (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
Measured by Experience of Caregiving Inventory (Szmukler et al., 1996), with selected subscales of Stigma (5 items), Effects on the Family (7 items), Positive Experience in Caregiving (14 items), assessing caregivers' experience in the caregiving relationship.
The Stigma score ranges from 0 (little experience of stigma) to 20 (much experience of stigma). The Effects on the Family score ranges from 0 (little negative effects on the family) to 28 (much negative effects on the family). The Positive Experience in Caregiving score ranges from 0 (little positive experience in caregiving) to 56 (much positive experience in caregiving).
No total scores are calculated.
Measured: (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
Physical health measured by 14 item, Physical Distress subscale in Body-Mind-Spirit Well-Being Inventory (Ng et al., 2005), assessing caregivers' level of subjective distress caused by specific physical symptoms; mental health, i.e., Anxiety and Depression, measured by Hospital Anxiety and Depression Scale (Zigmond \& Snaith, 1983), assessing caregivers' severity of anxiety and depression.
The Physical Distress score ranges from 0 (low distress) to 140 (high distress). The Anxiety score ranges from 0 (low anxiety) to 21 (high anxiety). The Depression score ranges from 0 (low depression) to 21 (high depression).
No total scores are calculated.
Measured: (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
Measured by WHO-5 Well-Being Index (Johansen, 1998), assessing caregivers' emotional well-being.
The total score ranges from 0 (bad well-being) to 25 (good well-being).
Measured: (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
Measured by 5 item, Family APGAR Scale (Smilkstein, Ashworth, \& Montano, 1982), with five subscales in adaptation, partnership, growth, affection and resolve, assessing parent's satisfaction of family functions.
The total score ranges from 0 (dissatisfaction) to 10 (good satisfaction).
Measured: (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
Measured by Mental Health Recovery Measure (Young \& Bullock, 2005), with 30 items in eight subscales relating to positive dimensions in recovery including Overcoming Stuckness (OS; 4 items), Self-Empowerment (SE; 4 items), Learning and Self-Redefinition (LSR; 4 items), Basic Functioning (BF; 4 items), Overall Well-Being (OWB; 4 items), New Potentials (NP; 4 items), Advocacy/Enrichment (A/E; 4 items) and Spirituality (2 items), assessing recovery-related experiences of people with severe mental illness.
The total score ranges from 0 (bad recovery-related experiences) to 120 (good recovery-related experiences).
OS, SE, LSR, BF, OWB, NP and A/E range from 0 (bad recovery-related experiences) to 16 (good recovery-related experiences).
Spirituality ranges from 0 (bad recovery-related experiences) to 8 (good recovery-related experiences).
Eight subscale scores are summed to compute a total score.
Measured: (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion
Change from baseline caregiver's interpersonal mindfulness at 6 weeks and at 12 months
Measured by the Interpersonal mindfulness in Parenting Scale (Duncan, 2007), with 23 items in four factors in Compassion for Child (CC), Emotional Awareness in Parenting (EAP), Nonjudgmental Acceptance in Parenting (NAP) and Listening with Full Awareness (LFA) (Lo et al., 2018), assessing caregivers' quality of mindfulness specific to his or her family context.
The total score ranges from 23 (low mindfulness) to 115 (high mindfulness). CC ranges from 7 (low compassion for child) to 35 (high compassion for child). EAP ranges from 6 (low emotional awareness in parenting) to 30 (high emotional awareness in parenting). NAP ranges from 6 (low nonjudgmental acceptance in parenting) to 30 (high nonjudgmental acceptance in parenting). LFA ranges from 4 (less likely listening with full awareness) to 20 (more likely listening with full awareness).
Four subscale scores are summed to compute a total score.
Measured: (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion
Change from baseline caregiver's non-attachment at 6 weeks and at 12 months
Measured by short form (8 items) of Non-attachment Scale (Sahdra, Shaver \& Brown, 2010), assessing caregivers' subjective level of nonattachment.
The total score ranges from 8 (low level of nonattachment) to 48 (high level of nonattachment).
Measured: (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion
Change from baseline youth's expressed emotion at 6 weeks and at 12 months
Measured by 12 item Level of Expressed Emotion Scale (Cole \& Kazarian, 1988), with subscales in Criticism (4 items), Hostility (4 items) and Over-Involvement (4 items), assessing patients' perceived expressed emotions from the most influential person.
The total score ranges from 12 (low perceived expressed emotions) to 48 (high perceived expressed emotions).
Criticism, Hostility and Over-Involvement scores range from 4 (low perceived expressed emotions from particular sources) to 16 (high perceived expressed emotions from particular sources).
Three subscale scores are summed to compute a total score.
Measured: (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion
Change from baseline youth's psychiatric symptom at 6 weeks and at 12 months
Measured by the Positive and Negative Syndrome Scale (PNSS) (Kay, Flszbein \& Opler, 1988), subscales in Positive Scale (7 items), Negative Scale (7 items) and General Psychopathology Scale (16 items), assessing students' psychiatric symptoms.
Positive Scale ranges from 7 (few positive syndromes) to 49 (many positive syndromes).
Negative Scale ranges from 7 (few negative syndromes) to 49 (many negative syndromes).
General Psychopathology Scale ranges from 16 (few general psychopathological symptoms) to 112 (many).
No total scores are calculated.
Measured: (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start1 Jan 2019
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisorderStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688009
- Sponsor's protocol ID
- 15604118
- Status last verified
- Feb 2024
- First submitted
- 11 Sep 2018
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39391083Zhang 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.
PubMed 36673773Lo 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.
PubMed 30915004
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Mindfulness-Based Family Psychoeducation Intervention for Chinese Students With Early Psychosis: A Mixed Methods Study
- ClinicalTrials.gov ID
- NCT03688009
- Acronym / sponsor ID
- 15604118
- Conditions
- Psychotic Disorder
- Keywords
- mindfulness-based intervention, family psychoeducation, Chinese family caregivers, early psychosis, mixed methods design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 27 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Family Psycho-Education (MBFBE) | Experimental | Behavioral: 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. |
| Family Psycho-Education (FPE) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Mindfulness-Based Family Psycho-Education (MBFBE) |
| 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. | Behavioural | Family Psycho-Education (FPE) |
Primary outcome
Change from baseline caregiver's general stress level at 6 weeks and at 12 months
Time frame: (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion
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).
9 secondary outcomes
Change from baseline caregiver's caregiving experiences at 6 weeks and at 12 months
Time frame: (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
Time frame: (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
Time frame: (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
Time frame: (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
Time frame: (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion
Change from baseline caregiver's interpersonal mindfulness at 6 weeks and at 12 months
Time frame: (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion
Change from baseline caregiver's non-attachment at 6 weeks and at 12 months
Time frame: (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion
Change from baseline youth's expressed emotion at 6 weeks and at 12 months
Time frame: (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion
Change from baseline youth's psychiatric symptom at 6 weeks and at 12 months
Time frame: (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Derived from this study: PubMed 39391083Zhang 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.
- Derived from this study: PubMed 36673773Zhang 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.
- Derived from this study: PubMed 30915004Lo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Family Psycho-Education (MBFBE) and Family Psycho-Education (FPE) in people with Psychotic Disorder, run by The Hong Kong Polytechnic University at 1 site 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 2 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 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change from baseline caregiver's general stress level at 6 weeks and at 12 months (time frame: (1) Pretest baseline, (2) through intervention completion, 6 weeks, and (3) 12-month follow up after intervention completion). 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 NCT03688009, which also lists 3 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 5 Mar 2024.