PsychosisMBIpNCT02244970
Mindfulness RCT for Early Psychosis
A study testing Mindfulness and Psychoeducation in people with Psychosis, run by The University of Hong Kong at 1 site in China.
Trial summary
Depressive mood and anxiety are prevalent in patients suffering from early psychosis. Treatments focused on these dimensions are rarely seen. Meanwhile, growing evidence showed Mindfulness-based intervention (MBI) as an effective option in handling depression and anxiety. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychosis
- What is being tested?
- Mindfulness and Psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Sep 2015
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cantonese-speaking patients aged 18-65, who are service users of the aforementioned community mental health services in Hong Kong.
- diagnosis of Schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, psychotic disorder not otherwise specified, or manic episodes with psychotic features according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) and less than 5 years' duration since onset of psychosis.
- present with mild depressive or anxiety symptoms (PANSS items G2 or G6 scores higher than or equal to 3; any item on CDSS scores more than or equal to 1).
- They must have an ability to consent, stable positive symptoms (PANSS symptomatic items: P1-P7 scores less than or equal to 3) and good medication compliance (assessed by clinical interview, informant interview, and pill-counting).
Who cannot join
- Known organic brain disorder
- Known history of intellectual disability,
- Diagnosed with drug-induced psychosis,
- Practice of mindfulness (in forms of yoga, Tai Chi, etc.) more than twice a week during the previous three months,
- Previous or current substance abuse,
- High risk features associated with acute psychotic episodes, and
- Questionable adherence to medication treatment and follow-up.
Trial locations and contacts
1 site in 1 country.
JingXia Lin, PhD contact
About this study
Official title: Brief Mindfulness-Based Intervention for Early Psychosis: A Randomized Controlled Study
Depressive mood and anxiety are prevalent in patients suffering from early psychosis. Treatments focused on these dimensions are rarely seen. Meanwhile, growing evidence showed Mindfulness-based intervention (MBI) as an effective option in handling depression and anxiety. There is a great possibility that MBI is also useful in depression and anxiety associating with early psychosis. Given that cost-effectiveness is widely concerned in Hong Kong or any other countries, a brief intervention is more favored. Current paper is a study protocol for a randomized controlled trial which assess the feasibility of a 7-week mindfulness-based intervention in patients with early psychosis targeting on their depressive mood and anxiety.
In this RCT, 60 patients aged 18-65 with early psychosis less than 5 years' duration and mild depressive mood or anxiety will be invited to join this single blind randomized controlled trial. After baseline assessments, eligible participants will be, using third party simple randomization, randomly assigned to either the 7-week Mindfulness-based Intervention (MBI), or the psychoeducation group as control.
Read more
The primary outcome is depressive mood and anxiety levels at post-intervention and 3 months. The secondary outcomes include life functioning, quality of life, other general clinical symptoms and mindfulness ability. Qualitative interviews will help evaluate and measure the feasibility of the intervention. Data will be analyzed according to the intention-to-treat principle.
This randomized trial offers an insight into mindfulness-based intervention and its effectiveness on psychosis concomitants. It provides the foundation for future evaluation and implementation of an effective and cost-efficient treatment option.
Read the detailed description
Psychosis is a set of symptoms associated with distorted perception and cognition. Clinical treatments that focus on positive symptoms, hallucination, and delusion are increasingly well developed throughout the century. However peripheral facets such as depressive mood (post-psychotic depression to its extreme) and anxiety have never been the foci of attention; they are often viewed as less important than positive, negative, or cognitive symptoms, if not entirely ignored. Sadly, depression and anxiety are prevalent in early psychotic patients. Depression was found in 22% of people with First Episode Psychosis (FEP), and anxiety disorders of social phobia was found in 32%, and obsessive compulsive disorder in 4-15% of people with FEP. These adverse conditions after the early acute stage of psychosis are linked with poor engagement in treatment services and adverse impact on the change process, resulting in poor treatment outcomes, lowered quality of life, and increased likelihood of suicide. Given the high prevalence and extensive impact, there is a need to explore adjunction intervention that targets mood and anxiety symptoms following onset of psychotic disorders.
Mindfulness is the awareness that emerges from paying attention to the present moment without judgment. It is a skill that can be achieved through meditation practices, and has been shown to improve general well-being. Mindfulness-based intervention (MBI) has been referred to as the "third wave" of psychological interventions after the first wave behavioral and the second wave cognitive interventions. Research relating to MBIs has increased exponentially in the past decade. Key, fully developed, MBIs in the literature include mindfulness-based stress reduction (MBSR), mindfulness-based cognitive therapy (MBCT) and acceptance and commitment therapy (ACT). These interventions are increasingly used with individuals suffering from depression or anxiety and have gained positive findings. Hofmann and colleagues conducted an effect size analysis on 39 studies of MBI for anxiety and mood symptoms in clinical samples. They found a moderately strong uncontrolled pre-post effect size of MBIs on reducing anxiety symptoms and depressive symptoms among individuals with disorders not limited to anxiety disorders or major depression. The authors postulated that MBIs may not be diagnosis-specific. Rather it is effective in reducing stress in general and hence improves symptoms of anxiety and depression across a relatively wide range of conditions.
Since MBIs are efficacious in reducing mood and anxiety symptoms across various disorders, it has potential intervention value for early psychosis as well. In a recent meta-review, Khoury and colleagues concluded that MBIs have moderate therapeutic effects for psychosis. At the same time, there are arguments against mindfulness practices on active psychotic patients, and in people at risk of developing psychosis. In response, Chadwick et al. demonstrated in a feasibility study the safe use of a mindfulness intervention on nine active psychotic patients. Given the small sample size, further careful research, especially randomized controlled trials (RCTs), is needed to support its usage .
Evidence on mindfulness-based interventions in treatment of mood and anxiety symptoms is encouraging. Yet, only a small number of RCTs have been conducted on patients with early psychosis to date. Further, with the limited resources available to the health system in Hong Kong, we aimed to create a simple MBI specific for early psychosis patients, with a user-friendly protocol that can be operated by health practitioners after sufficient yet time-efficient training. Therefore, the current RCT protocol in assessing the efficacy of a brief MBI on patients with early psychosis is of value.
The primary research question is whether positive changes on depressive and anxiety symptoms can be obtained through a 7-week MBI program designed for early psychotic patients. Specifically, we hypothesized that the anxiety level and depressive mood can be significantly reduced by our MBI. The second question we sought to answer is whether this change can be maintained, as reflected in a 3-month follow up. Our secondary hypotheses are that since depression and anxiety are lowered, those receiving the MBI will perceive having better quality of life and overall functioning as a result
- Conditions
- Psychosis
- Being tested
- Mindfulness, Psychoeducation
- Keywords
- Mindfulness, Depressive mood, anxiety, early psychosis
- Medical subject headings
- Psychotic Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessOther
Mindfulness is the awareness that emerges from paying attention to the present moment without judgment. In this study, subject in this arm will receive 7 weeks of MBI with a focus on tackling anxiety, depressed mood, and attention deficits among early psychosis participants. The elements of 7-week program included mindful-breathing, indoor and outdoor mindful-walking, mindful-eating, mindul-drawing, tree-of-life exercise and closing celebration.
PsychoeducationOther
Participants in the psychoeducation group will receive seven weeks of psychoeducation sessions which include basic knowledge related to 1) General mental health, 2) Knowledge of psychosis, 3) Treatment and community resources, 4) Recovery and relapse prevention, 5) Healthy lifestyle, 6) Social skills training, and finally a closing celebration at week 7.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | Subjects are scheduled to receive a 7-week group mindfulness-based intervention (MBI) program. Receives: Other: Mindfulness |
| Psychoeducation | Active comparator | Subjects will receive 7 weeks of group-based psychoeducation as an active comparison group parallel to the mindfulness group. Receives: Other: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive mood
Depressive mood is measured by the Positive and Negative Symptom Scale Item G2 (PANSS-G2); Calgary Depression Scale for Schizophrenics (CDSS); Depression Anxiety Stress Scale - Depression subscale (DASS-21-D) and Beck Depression Inventory - II (BDI-II).
Measured: 19weeks
Anxiety
Anxiety is measured by DASS-21 - Anxiety subscale and PANSS item G6.
Measured: 19weeks
Secondary outcomes (3)
Quality of Life
measured by Short Form 12 (SF12)
Measured: 19weeks
Life Functioning
rated on the Social and Occupational Functioning Assessment Scale (SOFAS)
Measured: 19weeks
Mindfulness
two separate mindfulness scales: the Five Facet Mindfulness Questionnaire (FFMQ) and the Southampton Mindfulness Questionnaire (SMQ).We also take note of the number of practices conducted individually by participants during each week of the intervention period and also the frequency of practice after the seven weeks of MBI.
Measured: 19weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Y H Chen, The University of Hong Kong
- Investigators
- JingXia Lin, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244970
- Sponsor's protocol ID
- MIND2014
- Acronym
- MBIp
- Status last verified
- Sep 2014
- First submitted
- 21 Aug 2014
- Last updated
- 19 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Mindfulness-Based Intervention for Early Psychosis: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02244970
- Acronym / sponsor ID
- MBIp / MIND2014
- Conditions
- Psychosis
- Keywords
- Mindfulness, Depressive mood, anxiety, early psychosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 19 Sep 2014 (estimated)
- 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.
Depressive mood and anxiety are prevalent in patients suffering from early psychosis. Treatments focused on these dimensions are rarely seen. Meanwhile, growing evidence showed Mindfulness-based intervention (MBI) as an effective option in handling depression and anxiety. There is a great possibility that MBI is also useful in depression and anxiety associating with early psychosis. Given that cost-effectiveness is widely concerned in Hong Kong or any other countries, a brief intervention is more favored. Current paper is a study protocol for a randomized controlled trial which assess the feasibility of a 7-week mindfulness-based intervention in patients with early psychosis targeting on their depressive mood and anxiety.
In this RCT, 60 patients aged 18-65 with early psychosis less than 5 years' duration and mild depressive mood or anxiety will be invited to join this single blind randomized controlled trial. After baseline assessments, eligible participants will be, using third party simple randomization, randomly assigned to either the 7-week Mindfulness-based Intervention (MBI), or the psychoeducation group as control.
The primary outcome is depressive mood and anxiety levels at post-intervention and 3 months. The secondary outcomes include life functioning, quality of life, other general clinical symptoms and mindfulness ability. Qualitative interviews will help evaluate and measure the feasibility of the intervention. Data will be analyzed according to the intention-to-treat principle.
This randomized trial offers an insight into mindfulness-based intervention and its effectiveness on psychosis concomitants. It provides the foundation for future evaluation and implementation of an effective and cost-efficient treatment option.
Detailed description
Psychosis is a set of symptoms associated with distorted perception and cognition. Clinical treatments that focus on positive symptoms, hallucination, and delusion are increasingly well developed throughout the century. However peripheral facets such as depressive mood (post-psychotic depression to its extreme) and anxiety have never been the foci of attention; they are often viewed as less important than positive, negative, or cognitive symptoms, if not entirely ignored. Sadly, depression and anxiety are prevalent in early psychotic patients. Depression was found in 22% of people with First Episode Psychosis (FEP), and anxiety disorders of social phobia was found in 32%, and obsessive compulsive disorder in 4-15% of people with FEP. These adverse conditions after the early acute stage of psychosis are linked with poor engagement in treatment services and adverse impact on the change process, resulting in poor treatment outcomes, lowered quality of life, and increased likelihood of suicide. Given the high prevalence and extensive impact, there is a need to explore adjunction intervention that targets mood and anxiety symptoms following onset of psychotic disorders.
Mindfulness is the awareness that emerges from paying attention to the present moment without judgment. It is a skill that can be achieved through meditation practices, and has been shown to improve general well-being. Mindfulness-based intervention (MBI) has been referred to as the "third wave" of psychological interventions after the first wave behavioral and the second wave cognitive interventions. Research relating to MBIs has increased exponentially in the past decade. Key, fully developed, MBIs in the literature include mindfulness-based stress reduction (MBSR), mindfulness-based cognitive therapy (MBCT) and acceptance and commitment therapy (ACT). These interventions are increasingly used with individuals suffering from depression or anxiety and have gained positive findings. Hofmann and colleagues conducted an effect size analysis on 39 studies of MBI for anxiety and mood symptoms in clinical samples. They found a moderately strong uncontrolled pre-post effect size of MBIs on reducing anxiety symptoms and depressive symptoms among individuals with disorders not limited to anxiety disorders or major depression. The authors postulated that MBIs may not be diagnosis-specific. Rather it is effective in reducing stress in general and hence improves symptoms of anxiety and depression across a relatively wide range of conditions.
Since MBIs are efficacious in reducing mood and anxiety symptoms across various disorders, it has potential intervention value for early psychosis as well. In a recent meta-review, Khoury and colleagues concluded that MBIs have moderate therapeutic effects for psychosis. At the same time, there are arguments against mindfulness practices on active psychotic patients, and in people at risk of developing psychosis. In response, Chadwick et al. demonstrated in a feasibility study the safe use of a mindfulness intervention on nine active psychotic patients. Given the small sample size, further careful research, especially randomized controlled trials (RCTs), is needed to support its usage .
Evidence on mindfulness-based interventions in treatment of mood and anxiety symptoms is encouraging. Yet, only a small number of RCTs have been conducted on patients with early psychosis to date. Further, with the limited resources available to the health system in Hong Kong, we aimed to create a simple MBI specific for early psychosis patients, with a user-friendly protocol that can be operated by health practitioners after sufficient yet time-efficient training. Therefore, the current RCT protocol in assessing the efficacy of a brief MBI on patients with early psychosis is of value.
The primary research question is whether positive changes on depressive and anxiety symptoms can be obtained through a 7-week MBI program designed for early psychotic patients. Specifically, we hypothesized that the anxiety level and depressive mood can be significantly reduced by our MBI. The second question we sought to answer is whether this change can be maintained, as reflected in a 3-month follow up. Our secondary hypotheses are that since depression and anxiety are lowered, those receiving the MBI will perceive having better quality of life and overall functioning as a result
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Other: MindfulnessSubjects are scheduled to receive a 7-week group mindfulness-based intervention (MBI) program. |
| Psychoeducation | Active comparator | Other: PsychoeducationSubjects will receive 7 weeks of group-based psychoeducation as an active comparison group parallel to the mindfulness group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cantonese-speaking patients aged 18-65, who are service users of the aforementioned community mental health services in Hong Kong.
- diagnosis of Schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, psychotic disorder not otherwise specified, or manic episodes with psychotic features according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) and less than 5 years' duration since onset of psychosis.
- present with mild depressive or anxiety symptoms (PANSS items G2 or G6 scores higher than or equal to 3; any item on CDSS scores more than or equal to 1).
- They must have an ability to consent, stable positive symptoms (PANSS symptomatic items: P1-P7 scores less than or equal to 3) and good medication compliance (assessed by clinical interview, informant interview, and pill-counting).
Key exclusion criteria (7 listed)
- Known organic brain disorder
- Known history of intellectual disability,
- Diagnosed with drug-induced psychosis,
- Practice of mindfulness (in forms of yoga, Tai Chi, etc.) more than twice a week during the previous three months,
- Previous or current substance abuse,
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 |
|---|---|---|
| MindfulnessMindfulness is the awareness that emerges from paying attention to the present moment without judgment. In this study, subject in this arm will receive 7 weeks of MBI with a focus on tackling anxiety, depressed mood, and attention deficits among early psychosis participants. The elements of 7-week program included mindful-breathing, indoor and outdoor mindful-walking, mindful-eating, mindul-drawing, tree-of-life exercise and closing celebration. | Other | Mindfulness |
| PsychoeducationParticipants in the psychoeducation group will receive seven weeks of psychoeducation sessions which include basic knowledge related to 1) General mental health, 2) Knowledge of psychosis, 3) Treatment and community resources, 4) Recovery and relapse prevention, 5) Healthy lifestyle, 6) Social skills training, and finally a closing celebration at week 7. | Other | Psychoeducation |
Primary outcome
Depressive mood
Time frame: 19weeks
Depressive mood is measured by the Positive and Negative Symptom Scale Item G2 (PANSS-G2); Calgary Depression Scale for Schizophrenics (CDSS); Depression Anxiety Stress Scale - Depression subscale (DASS-21-D) and Beck Depression Inventory - II (BDI-II).
Anxiety
Time frame: 19weeks
Anxiety is measured by DASS-21 - Anxiety subscale and PANSS item G6.
3 secondary outcomes
Quality of Life
Time frame: 19weeks
Life Functioning
Time frame: 19weeks
Mindfulness
Time frame: 19weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2014.
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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.
JingXia Lin, PhD contact
JingXia Lin, PhD principal investigator
The University of Hong Kong
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 and Psychoeducation in people with Psychosis, run by The University of Hong Kong at 1 site in China.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Sep 2014. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JingXia Lin, PhD (jingxia.lin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive mood (time frame: 19weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2014.