Ignite Creation Date:
2024-05-06 @ 3:15 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02244970
Status:
UNKNOWN
Last Update Posted:
2014-09-19
First Post:
2014-08-21
Brief Title:
Mindfulness RCT for Early Psychosis
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Brief Mindfulness-Based Intervention for Early Psychosis A Randomized Controlled Study
Status:
UNKNOWN
Status Verified Date:
2014-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MBIp
Brief 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 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None