<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02244970</url>
  </required_header>
  <id_info>
    <org_study_id>MIND2014</org_study_id>
    <nct_id>NCT02244970</nct_id>
  </id_info>
  <brief_title>Mindfulness RCT for Early Psychosis</brief_title>
  <acronym>MBIp</acronym>
  <official_title>Brief Mindfulness-Based Intervention for Early Psychosis: A Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Depressive mood and anxiety are prevalent in patients suffering from early psychosis.&#xD;
      Treatments focused on these dimensions are rarely seen. Meanwhile, growing evidence showed&#xD;
      Mindfulness-based intervention (MBI) as an effective option in handling depression and&#xD;
      anxiety. There is a great possibility that MBI is also useful in depression and anxiety&#xD;
      associating with early psychosis. Given that cost-effectiveness is widely concerned in Hong&#xD;
      Kong or any other countries, a brief intervention is more favored. Current paper is a study&#xD;
      protocol for a randomized controlled trial which assess the feasibility of a 7-week&#xD;
      mindfulness-based intervention in patients with early psychosis targeting on their depressive&#xD;
      mood and anxiety.&#xD;
&#xD;
      In this RCT, 60 patients aged 18-65 with early psychosis less than 5 years' duration and mild&#xD;
      depressive mood or anxiety will be invited to join this single blind randomized controlled&#xD;
      trial. After baseline assessments, eligible participants will be, using third party simple&#xD;
      randomization, randomly assigned to either the 7-week Mindfulness-based Intervention (MBI),&#xD;
      or the psychoeducation group as control.&#xD;
&#xD;
      The primary outcome is depressive mood and anxiety levels at post-intervention and 3 months.&#xD;
      The secondary outcomes include life functioning, quality of life, other general clinical&#xD;
      symptoms and mindfulness ability. Qualitative interviews will help evaluate and measure the&#xD;
      feasibility of the intervention. Data will be analyzed according to the intention-to-treat&#xD;
      principle.&#xD;
&#xD;
      This randomized trial offers an insight into mindfulness-based intervention and its&#xD;
      effectiveness on psychosis concomitants. It provides the foundation for future evaluation and&#xD;
      implementation of an effective and cost-efficient treatment option.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Psychosis is a set of symptoms associated with distorted perception and cognition. Clinical&#xD;
      treatments that focus on positive symptoms, hallucination, and delusion are increasingly well&#xD;
      developed throughout the century. However peripheral facets such as depressive mood&#xD;
      (post-psychotic depression to its extreme) and anxiety have never been the foci of attention;&#xD;
      they are often viewed as less important than positive, negative, or cognitive symptoms, if&#xD;
      not entirely ignored. Sadly, depression and anxiety are prevalent in early psychotic&#xD;
      patients. Depression was found in 22% of people with First Episode Psychosis (FEP), and&#xD;
      anxiety disorders of social phobia was found in 32%, and obsessive compulsive disorder in&#xD;
      4-15% of people with FEP. These adverse conditions after the early acute stage of psychosis&#xD;
      are linked with poor engagement in treatment services and adverse impact on the change&#xD;
      process, resulting in poor treatment outcomes, lowered quality of life, and increased&#xD;
      likelihood of suicide. Given the high prevalence and extensive impact, there is a need to&#xD;
      explore adjunction intervention that targets mood and anxiety symptoms following onset of&#xD;
      psychotic disorders.&#xD;
&#xD;
      Mindfulness is the awareness that emerges from paying attention to the present moment without&#xD;
      judgment. It is a skill that can be achieved through meditation practices, and has been shown&#xD;
      to improve general well-being. Mindfulness-based intervention (MBI) has been referred to as&#xD;
      the &quot;third wave&quot; of psychological interventions after the first wave behavioral and the&#xD;
      second wave cognitive interventions. Research relating to MBIs has increased exponentially in&#xD;
      the past decade. Key, fully developed, MBIs in the literature include mindfulness-based&#xD;
      stress reduction (MBSR), mindfulness-based cognitive therapy (MBCT) and acceptance and&#xD;
      commitment therapy (ACT). These interventions are increasingly used with individuals&#xD;
      suffering from depression or anxiety and have gained positive findings. Hofmann and&#xD;
      colleagues conducted an effect size analysis on 39 studies of MBI for anxiety and mood&#xD;
      symptoms in clinical samples. They found a moderately strong uncontrolled pre-post effect&#xD;
      size of MBIs on reducing anxiety symptoms and depressive symptoms among individuals with&#xD;
      disorders not limited to anxiety disorders or major depression. The authors postulated that&#xD;
      MBIs may not be diagnosis-specific. Rather it is effective in reducing stress in general and&#xD;
      hence improves symptoms of anxiety and depression across a relatively wide range of&#xD;
      conditions.&#xD;
&#xD;
      Since MBIs are efficacious in reducing mood and anxiety symptoms across various disorders, it&#xD;
      has potential intervention value for early psychosis as well. In a recent meta-review, Khoury&#xD;
      and colleagues concluded that MBIs have moderate therapeutic effects for psychosis. At the&#xD;
      same time, there are arguments against mindfulness practices on active psychotic patients,&#xD;
      and in people at risk of developing psychosis. In response, Chadwick et al. demonstrated in a&#xD;
      feasibility study the safe use of a mindfulness intervention on nine active psychotic&#xD;
      patients. Given the small sample size, further careful research, especially randomized&#xD;
      controlled trials (RCTs), is needed to support its usage .&#xD;
&#xD;
      Evidence on mindfulness-based interventions in treatment of mood and anxiety symptoms is&#xD;
      encouraging. Yet, only a small number of RCTs have been conducted on patients with early&#xD;
      psychosis to date. Further, with the limited resources available to the health system in Hong&#xD;
      Kong, we aimed to create a simple MBI specific for early psychosis patients, with a&#xD;
      user-friendly protocol that can be operated by health practitioners after sufficient yet&#xD;
      time-efficient training. Therefore, the current RCT protocol in assessing the efficacy of a&#xD;
      brief MBI on patients with early psychosis is of value.&#xD;
&#xD;
      The primary research question is whether positive changes on depressive and anxiety symptoms&#xD;
      can be obtained through a 7-week MBI program designed for early psychotic patients.&#xD;
      Specifically, we hypothesized that the anxiety level and depressive mood can be significantly&#xD;
      reduced by our MBI. The second question we sought to answer is whether this change can be&#xD;
      maintained, as reflected in a 3-month follow up. Our secondary hypotheses are that since&#xD;
      depression and anxiety are lowered, those receiving the MBI will perceive having better&#xD;
      quality of life and overall functioning as a result&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depressive mood</measure>
    <time_frame>19weeks</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety</measure>
    <time_frame>19weeks</time_frame>
    <description>Anxiety is measured by DASS-21 - Anxiety subscale and PANSS item G6.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>19weeks</time_frame>
    <description>measured by Short Form 12 (SF12)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Life Functioning</measure>
    <time_frame>19weeks</time_frame>
    <description>rated on the Social and Occupational Functioning Assessment Scale (SOFAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mindfulness</measure>
    <time_frame>19weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Program evaluation</measure>
    <time_frame>19weeks</time_frame>
    <description>In order to evaluate the MBI for further development and to assist interpretation of results, qualitative semi-structured interviews will be conducted after the seven weeks of MBI. The interview primarily looks at the perceived processes of change, helpful aspects of the process, and therapeutic value of the MBI. Each interview will be recorded and transcribed</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Psychosis</condition>
  <arm_group>
    <arm_group_label>Mindfulness</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects are scheduled to receive a 7-week group mindfulness-based intervention (MBI) program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Psychoeducation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive 7 weeks of group-based psychoeducation as an active comparison group parallel to the mindfulness group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mindfulness</intervention_name>
    <description>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.</description>
    <arm_group_label>Mindfulness</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Psychoeducation</intervention_name>
    <description>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.</description>
    <arm_group_label>Psychoeducation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cantonese-speaking patients aged 18-65, who are service users of the aforementioned&#xD;
             community mental health services in Hong Kong.&#xD;
&#xD;
          -  diagnosis of Schizophrenia, schizophreniform disorder, schizoaffective disorder,&#xD;
             delusional disorder, brief psychotic disorder, psychotic disorder not otherwise&#xD;
             specified, or manic episodes with psychotic features according to the Diagnostic and&#xD;
             Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) and less than 5 years'&#xD;
             duration since onset of psychosis.&#xD;
&#xD;
          -  present with mild depressive or anxiety symptoms (PANSS items G2 or G6 scores higher&#xD;
             than or equal to 3; any item on CDSS scores more than or equal to 1).&#xD;
&#xD;
          -  They must have an ability to consent, stable positive symptoms (PANSS symptomatic&#xD;
             items: P1-P7 scores less than or equal to 3) and good medication compliance (assessed&#xD;
             by clinical interview, informant interview, and pill-counting).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known organic brain disorder&#xD;
&#xD;
          -  Known history of intellectual disability,&#xD;
&#xD;
          -  Diagnosed with drug-induced psychosis,&#xD;
&#xD;
          -  Practice of mindfulness (in forms of yoga, Tai Chi, etc.) more than twice a week&#xD;
             during the previous three months,&#xD;
&#xD;
          -  Previous or current substance abuse,&#xD;
&#xD;
          -  High risk features associated with acute psychotic episodes, and&#xD;
&#xD;
          -  Questionable adherence to medication treatment and follow-up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>JingXia Lin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>JingXia Lin, PhD</last_name>
    <email>jingxia.lin@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 16, 2014</last_update_submitted>
  <last_update_submitted_qc>September 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Eric Y H Chen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Mindfulness</keyword>
  <keyword>Depressive mood</keyword>
  <keyword>anxiety</keyword>
  <keyword>early psychosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psychotic Disorders</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02244970
org study id: MIND2014
nct id: NCT02244970
lead sponsor: 
has dmc: No
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.
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Depressive mood
time frame: 19weeks
description: 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).
measure: Anxiety
time frame: 19weeks
description: Anxiety is measured by DASS-21 - Anxiety subscale and PANSS item G6.
measure: Quality of Life
time frame: 19weeks
description: measured by Short Form 12 (SF12)
measure: Life Functioning
time frame: 19weeks
description: rated on the Social and Occupational Functioning Assessment Scale (SOFAS)
measure: Mindfulness
time frame: 19weeks
description: 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.
measure: Program evaluation
time frame: 19weeks
description: In order to evaluate the MBI for further development and to assist interpretation of results, qualitative semi-structured interviews will be conducted after the seven weeks of MBI. The interview primarily looks at the perceived processes of change, helpful aspects of the process, and therapeutic value of the MBI. Each interview will be recorded and transcribed
arm group label: Mindfulness
arm group type: Experimental
description: Subjects are scheduled to receive a 7-week group mindfulness-based intervention (MBI) program.
arm group label: Psychoeducation
arm group type: Active Comparator
description: Subjects will receive 7 weeks of group-based psychoeducation as an active comparison group parallel to the mindfulness group.
intervention type: Other
intervention name: Mindfulness
description: 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.
arm group label: Mindfulness
intervention type: Other
intervention name: Psychoeducation
description: 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.
arm group label: Psychoeducation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: JingXia Lin, PhD
role: Principal Investigator
affiliation: The University of Hong Kong
last name: JingXia Lin, PhD
email: jingxia.lin@gmail.com
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Eric Y H Chen
investigator title: Professor
mesh term: Psychotic Disorders
mesh term: Mental Disorders