xml: <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/NCT06017388</url>
    </required_header>
    <id_info>
      <org_study_id>2022-213</org_study_id>
      <nct_id>NCT06017388</nct_id>
    </id_info>
    <brief_title>Mystical Experience in Hypnosis: a Neurophenomenological Study</brief_title>
    <acronym>MystHyp</acronym>
    <official_title>A Neurophenomenological Study of Hypnosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Liege</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Liege</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Mystical experience is described as an experience that is unique to everyone, potentially&#xD;
        transformative and leaving a mark for many years or even a lifetime. It is characterized by:&#xD;
        a loss of self/ego, being with the whole/nature/universe, transcendence, a loss of&#xD;
        spatio-temporal reference points, ineffability, peace and joy, a sacred character, and a&#xD;
        noetic quality. The mystical experience is one that occurs in the context of non-ordinary&#xD;
        states of consciousness such as meditation and the consumption of so-called psychedelic&#xD;
        drugs, for example. It would seem, in fact, to correspond to the transformative mechanism of&#xD;
        the psychedelic experience. The goal ofthis study is to investigate the possibility of a&#xD;
        mystical experience through hypnosis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Anyone interested in taking part in the study will be contacted by telephone or e-mail and&#xD;
        offered a face-to-face appointment to carry out the screening (T0). During the appointment,&#xD;
        screening (cf. inclusion criteria) will be carried out, socio-demographic data (age, sex,&#xD;
        education, nationality, history of hypnosis practice, etc.) and randomization will also take&#xD;
        place at this time. At this time, the investigators will assess psychological flexibility and&#xD;
        psychologigal well-being, and participants will do a cognitive flexibility task (T1). If&#xD;
        people meet the inclusion criteria, the investigators will schedule an appointment for a&#xD;
        session to take place roughly a week later.&#xD;
  &#xD;
        During this session, the investigators will start by reviewing beliefs about hypnosis,&#xD;
        assessing participants' expectations of the study, their absorption and dissociation trait,&#xD;
        their positive and negative affects and their anxiety. Next, the investigators will perform a&#xD;
        15-minute resting electroencephalographic (EEG) recording. We will then administer the Elkins&#xD;
        Hypnotizability Scale. A 30-minute break will be taken. Next, the investigators willperform a&#xD;
        hypnotic induction followed by a mystical experience suggestion for the experimental group.&#xD;
        The control group will simply receive a reading of the mystical experience suggestion without&#xD;
        hypnosis. The rest of the procedure is the same for both groups. EEG activity will be&#xD;
        recorded during the mystical experience suggestion (± 15 minutes) in hypnosis and outside&#xD;
        hypnosis (ordinary state of consciousness). Directly afterwards, participants will be asked&#xD;
        to orally explain their subjective experience during the suggestion of mystical experience.&#xD;
        Then the investigators will assess the positive and negative affect in addition to these&#xD;
        outcomes: the mystical experience, the ego dissolution, the psychological flexibility, the&#xD;
        cognitive flexibility, the altered state of consciousness, the near-death experience,&#xD;
        alterness, absorption state, dissociation state, time perception (T2).&#xD;
  &#xD;
        Three months after receiving the experimental session, participants will be seen again for a&#xD;
        follow-up session (T3). During this session, we will ask: &quot;Since the experimental session,&#xD;
        have you observed any changes in your behaviors, emotions and beliefs? If so, can you tell us&#xD;
        about them?&quot;. The investigators will assess the positive and negative affects and&#xD;
        psychological well-being.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mystical experience</measure>
      <time_frame>During the procedure</time_frame>
      <description>The 30-item revised Mystical Experience Questionnaire will assess the occurrence and intensity of mystical-type experiences. It is comprised of four factors: mysticality, positivity of mood, transcendence of time and space, and ineffability. A mystical experience is defined as having a score equal or above 60% on all factors.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hypnotizability</measure>
      <time_frame>During the procedure</time_frame>
      <description>The susceptibility one has concerning hypnosis. Will be assessed with the Elkins Hypnotizability Scale. A score :&#xD;
  0-3 : low hypnotizability 4-7: medium hypnotizability 8-11 : high hypnotizability 12 : very high hypnotizability.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Ego Dissolution</measure>
      <time_frame>During the procedure</time_frame>
      <description>The Ego Dissolution Inventory will assess the occurrence of ego dissolution.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Alteration of consciousness</measure>
      <time_frame>During the procedure</time_frame>
      <description>The Phenomenology of Consciousness Inventory will allow to empirically quantify the subjective experience in terms of pattern and intensity parameters. It is composed of 53 items consisting of 12 major dimensions (e.g., positive affect), and 14 minor dimensions (e.g., absorption) (annex). Graphs will be constructed to represent the intensity and pattern of relationships between pairs of dimensions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Psychological flexibility</measure>
      <time_frame>Before the procedure and direclty after the procedure</time_frame>
      <description>Multidimensional Psychological Flexibility Inventory.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive flexibility</measure>
      <time_frame>Before the procedure and direclty after the procedure</time_frame>
      <description>Cognitive flexility will be assessed with the Test of Attentional Performance which is an informatized cognitive task.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Psychological well-being</measure>
      <time_frame>Before the intervention and after 3 months</time_frame>
      <description>Psychological well-being will be assessed with the Warwick-Edinburgh Mental Well-Being Scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Modification of mood, cognition, emotion and behavior</measure>
      <time_frame>After 3 months</time_frame>
      <description>We will ask an open-ended question &quot;Since the experimental session, have you observed any changes in your behaviors, emotions and beliefs? If so, can you tell us about them?&quot;.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Phenomenal experience</measure>
      <time_frame>During the procedure</time_frame>
      <description>Phenomenal experience will be assessed by the recording of the narrative experience.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Socio-demographics</measure>
      <time_frame>At screening</time_frame>
      <description>age, sex, éducation, nationality, prior practice of hypnosis or other non-ordinary states of consciousness, prior mystical experience.</description>
    </other_outcome>
    <other_outcome>
      <measure>Psychiatric screening</measure>
      <time_frame>At screening</time_frame>
      <description>Psychiatric screening will be assessed with the Mini-International Neuropsychiatric Interview</description>
    </other_outcome>
    <other_outcome>
      <measure>Beliefs about hypnosis</measure>
      <time_frame>Before the procedure</time_frame>
      <description>Beliefs about hypnosis will be assessed with an open-ended question &quot;What are your beliefs about hypnosis?&quot;</description>
    </other_outcome>
    <other_outcome>
      <measure>Expectancies about the study</measure>
      <time_frame>Before the procedure</time_frame>
      <description>Expectancies about the study will be assessed with an open-ended question &quot;What are your expectancies about the study?&quot;</description>
    </other_outcome>
    <other_outcome>
      <measure>Phenomenal control</measure>
      <time_frame>During the procedure</time_frame>
      <description>The phenomenal control will be assessed with the Phenomenological Control Scale.</description>
    </other_outcome>
    <other_outcome>
      <measure>Positive and negative affects</measure>
      <time_frame>Beforethe procedure, During the procedure, direcly after the procedure, and after 3 months</time_frame>
      <description>Positive and negative affects will be assessed with the Positive Affect and Negative Affect.</description>
    </other_outcome>
    <other_outcome>
      <measure>Absorption trait</measure>
      <time_frame>Before the procedure</time_frame>
      <description>The absorption trait will be assessed with the Tellegen Absorption Scale which consists of 34 true/false items, aiming to measure the absorption of a person, meaning the disposition for having episodes of a deep involvement that engage all the subject's resources (perceptual, imaginative, and cognitive). The total score range is from 0 to 34. The higher the score, the more one has a high propensity for absorption.</description>
    </other_outcome>
    <other_outcome>
      <measure>Dissociation trait</measure>
      <time_frame>Before the procedure</time_frame>
      <description>The dissociation trait will be assessed with the Dissociative Experience Scale. It is a self-reported questionnaire used to evaluate the presence, quantity, and type of dissociative experiences one might live in daily life. It consists of 28 items arranged on an analog scale (from 0 to 100% measuring the frequency of dissociative experiences), and the total score ranges from 0 to 100. There is a cutoff of 45 as a mean score to suggest a dissociative disorder. This questionnaire is not a diagnostic instrument; it is designed only for screening, but it can suggest that a specific clinical assessment is needed.</description>
    </other_outcome>
    <other_outcome>
      <measure>Anxiety state</measure>
      <time_frame>Before the procedure and during the procedure</time_frame>
      <description>Anxiety will be assessed with a numerical rating scale.</description>
    </other_outcome>
    <other_outcome>
      <measure>Absorption state</measure>
      <time_frame>During the procedure</time_frame>
      <description>Absorption will be assessed with a numerical rating scale.</description>
    </other_outcome>
    <other_outcome>
      <measure>Dissociation state</measure>
      <time_frame>During the procedure</time_frame>
      <description>Dissociation will be assessed with a numerical rating scale.</description>
    </other_outcome>
    <other_outcome>
      <measure>Alertness</measure>
      <time_frame>During the procedure</time_frame>
      <description>Alertness will be assessed with a numerical rating scale.</description>
    </other_outcome>
    <other_outcome>
      <measure>Time perception</measure>
      <time_frame>During the procedure</time_frame>
      <description>We will ask the participants how long they thought the intervention lasted.</description>
    </other_outcome>
    <other_outcome>
      <measure>Near Death Experience</measure>
      <time_frame>During the procedure</time_frame>
      <description>The near death experience will be assessed with the The Near-Death Experience Content (NDE-C) Scale.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The control group will simply receive a reading of the mystical experience suggestion without hypnosis.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experiemental</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The experiemental group will receive a suggestion of the mystical experience in hypnosis.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Hypnosis</intervention_name>
      <description>We will propose a hypnotic induction followed by a suggestion of mystical experience (based on Lynn &amp; Evans, 2017).</description>
      <arm_group_label>Experiemental</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Control</intervention_name>
      <description>We will propose the neutral reading of a mystical expetience suggestion (based on Lynn &amp; Evans, 2017).</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  at least 18 years old&#xD;
  &#xD;
            -  good comprehension of French&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Psychiatric history&#xD;
  &#xD;
            -  History of neurological disorder&#xD;
  &#xD;
            -  Psychoactive medication&#xD;
  &#xD;
            -  Addiction&#xD;
  &#xD;
            -  Alcoholism&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Aminata Bicego</last_name>
      <phone>+3243663499</phone>
      <email>abicego@uliege.be</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Audrey Vanhaudenhuyse</last_name>
      <phone>+3243238033</phone>
      <email>avanhaudenhuyse@chuliege.be</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Liege</investigator_affiliation>
      <investigator_full_name>Bicego Aminata</investigator_full_name>
      <investigator_title>PhD</investigator_title>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06017388
  org study id: 2022-213
  nct id: NCT06017388
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Mystical experience is described as an experience that is unique to everyone, potentially
        transformative and leaving a mark for many years or even a lifetime. It is characterized by:
        a loss of self/ego, being with the whole/nature/universe, transcendence, a loss of
        spatio-temporal reference points, ineffability, peace and joy, a sacred character, and a
        noetic quality. The mystical experience is one that occurs in the context of non-ordinary
        states of consciousness such as meditation and the consumption of so-called psychedelic
        drugs, for example. It would seem, in fact, to correspond to the transformative mechanism of
        the psychedelic experience. The goal ofthis study is to investigate the possibility of a
        mystical experience through hypnosis.
  Anyone interested in taking part in the study will be contacted by telephone or e-mail and
        offered a face-to-face appointment to carry out the screening (T0). During the appointment,
        screening (cf. inclusion criteria) will be carried out, socio-demographic data (age, sex,
        education, nationality, history of hypnosis practice, etc.) and randomization will also take
        place at this time. At this time, the investigators will assess psychological flexibility and
        psychologigal well-being, and participants will do a cognitive flexibility task (T1). If
        people meet the inclusion criteria, the investigators will schedule an appointment for a
        session to take place roughly a week later.
  
        During this session, the investigators will start by reviewing beliefs about hypnosis,
        assessing participants' expectations of the study, their absorption and dissociation trait,
        their positive and negative affects and their anxiety. Next, the investigators will perform a
        15-minute resting electroencephalographic (EEG) recording. We will then administer the Elkins
        Hypnotizability Scale. A 30-minute break will be taken. Next, the investigators willperform a
        hypnotic induction followed by a mystical experience suggestion for the experimental group.
        The control group will simply receive a reading of the mystical experience suggestion without
        hypnosis. The rest of the procedure is the same for both groups. EEG activity will be
        recorded during the mystical experience suggestion (± 15 minutes) in hypnosis and outside
        hypnosis (ordinary state of consciousness). Directly afterwards, participants will be asked
        to orally explain their subjective experience during the suggestion of mystical experience.
        Then the investigators will assess the positive and negative affect in addition to these
        outcomes: the mystical experience, the ego dissolution, the psychological flexibility, the
        cognitive flexibility, the altered state of consciousness, the near-death experience,
        alterness, absorption state, dissociation state, time perception (T2).
  
        Three months after receiving the experimental session, participants will be seen again for a
        follow-up session (T3). During this session, we will ask: "Since the experimental session,
        have you observed any changes in your behaviors, emotions and beliefs? If so, can you tell us
        about them?". The investigators will assess the positive and negative affects and
        psychological well-being.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Mystical experience
  time frame: During the procedure
  description: The 30-item revised Mystical Experience Questionnaire will assess the occurrence and intensity of mystical-type experiences. It is comprised of four factors: mysticality, positivity of mood, transcendence of time and space, and ineffability. A mystical experience is defined as having a score equal or above 60% on all factors.
  measure: Hypnotizability
  time frame: During the procedure
  description: The susceptibility one has concerning hypnosis. Will be assessed with the Elkins Hypnotizability Scale. A score :
  0-3 : low hypnotizability 4-7: medium hypnotizability 8-11 : high hypnotizability 12 : very high hypnotizability.
  measure: Ego Dissolution
  time frame: During the procedure
  description: The Ego Dissolution Inventory will assess the occurrence of ego dissolution.
  measure: Alteration of consciousness
  time frame: During the procedure
  description: The Phenomenology of Consciousness Inventory will allow to empirically quantify the subjective experience in terms of pattern and intensity parameters. It is composed of 53 items consisting of 12 major dimensions (e.g., positive affect), and 14 minor dimensions (e.g., absorption) (annex). Graphs will be constructed to represent the intensity and pattern of relationships between pairs of dimensions.
  measure: Psychological flexibility
  time frame: Before the procedure and direclty after the procedure
  description: Multidimensional Psychological Flexibility Inventory.
  measure: Cognitive flexibility
  time frame: Before the procedure and direclty after the procedure
  description: Cognitive flexility will be assessed with the Test of Attentional Performance which is an informatized cognitive task.
  measure: Psychological well-being
  time frame: Before the intervention and after 3 months
  description: Psychological well-being will be assessed with the Warwick-Edinburgh Mental Well-Being Scale
  measure: Modification of mood, cognition, emotion and behavior
  time frame: After 3 months
  description: We will ask an open-ended question "Since the experimental session, have you observed any changes in your behaviors, emotions and beliefs? If so, can you tell us about them?".
  measure: Phenomenal experience
  time frame: During the procedure
  description: Phenomenal experience will be assessed by the recording of the narrative experience.
  measure: Socio-demographics
  time frame: At screening
  description: age, sex, éducation, nationality, prior practice of hypnosis or other non-ordinary states of consciousness, prior mystical experience.
  measure: Psychiatric screening
  time frame: At screening
  description: Psychiatric screening will be assessed with the Mini-International Neuropsychiatric Interview
  measure: Beliefs about hypnosis
  time frame: Before the procedure
  description: Beliefs about hypnosis will be assessed with an open-ended question "What are your beliefs about hypnosis?"
  measure: Expectancies about the study
  time frame: Before the procedure
  description: Expectancies about the study will be assessed with an open-ended question "What are your expectancies about the study?"
  measure: Phenomenal control
  time frame: During the procedure
  description: The phenomenal control will be assessed with the Phenomenological Control Scale.
  measure: Positive and negative affects
  time frame: Beforethe procedure, During the procedure, direcly after the procedure, and after 3 months
  description: Positive and negative affects will be assessed with the Positive Affect and Negative Affect.
  measure: Absorption trait
  time frame: Before the procedure
  description: The absorption trait will be assessed with the Tellegen Absorption Scale which consists of 34 true/false items, aiming to measure the absorption of a person, meaning the disposition for having episodes of a deep involvement that engage all the subject's resources (perceptual, imaginative, and cognitive). The total score range is from 0 to 34. The higher the score, the more one has a high propensity for absorption.
  measure: Dissociation trait
  time frame: Before the procedure
  description: The dissociation trait will be assessed with the Dissociative Experience Scale. It is a self-reported questionnaire used to evaluate the presence, quantity, and type of dissociative experiences one might live in daily life. It consists of 28 items arranged on an analog scale (from 0 to 100% measuring the frequency of dissociative experiences), and the total score ranges from 0 to 100. There is a cutoff of 45 as a mean score to suggest a dissociative disorder. This questionnaire is not a diagnostic instrument; it is designed only for screening, but it can suggest that a specific clinical assessment is needed.
  measure: Anxiety state
  time frame: Before the procedure and during the procedure
  description: Anxiety will be assessed with a numerical rating scale.
  measure: Absorption state
  time frame: During the procedure
  description: Absorption will be assessed with a numerical rating scale.
  measure: Dissociation state
  time frame: During the procedure
  description: Dissociation will be assessed with a numerical rating scale.
  measure: Alertness
  time frame: During the procedure
  description: Alertness will be assessed with a numerical rating scale.
  measure: Time perception
  time frame: During the procedure
  description: We will ask the participants how long they thought the intervention lasted.
  measure: Near Death Experience
  time frame: During the procedure
  description: The near death experience will be assessed with the The Near-Death Experience Content (NDE-C) Scale.
  arm group label: Control
  arm group type: Active Comparator
  description: The control group will simply receive a reading of the mystical experience suggestion without hypnosis.
  arm group label: Experiemental
  arm group type: Experimental
  description: The experiemental group will receive a suggestion of the mystical experience in hypnosis.
  intervention type: Behavioral
  intervention name: Hypnosis
  description: We will propose a hypnotic induction followed by a suggestion of mystical experience (based on Lynn & Evans, 2017).
  arm group label: Experiemental
  intervention type: Behavioral
  intervention name: Control
  description: We will propose the neutral reading of a mystical expetience suggestion (based on Lynn & Evans, 2017).
  arm group label: Control
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Aminata Bicego
  phone: +3243663499
  email: abicego@uliege.be
  last name: Audrey Vanhaudenhuyse
  phone: +3243238033
  email: avanhaudenhuyse@chuliege.be
  responsible party type: Principal Investigator
  investigator affiliation: University of Liege
  investigator full name: Bicego Aminata
  investigator title: PhD