<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/NCT04429789</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00007428</org_study_id>
    <secondary_id>PP-1904-33857</secondary_id>
    <nct_id>NCT04429789</nct_id>
  </id_info>
  <brief_title>Waking Hypnosis in the Treatment of MS-related Fatigue</brief_title>
  <acronym>POWER-UP</acronym>
  <official_title>Waking Hypnosis in the Treatment of MS-related Fatigue: Pilot and Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Multiple Sclerosis Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>No</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>
      The proposed study is a single-center, single-blind three-group randomized (1:1:1) controlled&#xD;
      trial (RCT) comparing two hypnosis interventions to waitlist control efficacy for MS-related&#xD;
      fatigue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This project will test the efficacy of two different hypnosis approaches for improving&#xD;
      MS-related fatigue that have shown to be beneficial for individuals with cancer and other&#xD;
      medical conditions in the management of their symptoms. One of these methods, the&#xD;
      active-alert hypnosis has helped people to manage fatigue and may have important advantages&#xD;
      over the more traditional relaxation hypnotic approaches in the treatment of fatigue, since&#xD;
      the hypnotic inductions and the self-hypnosis methods use activation instead of relaxation.&#xD;
      Therefore, the goals of this study are to determine if a comparison study of these two&#xD;
      hypnotic conditions is feasible, and, if so, to determine which treatment may be more&#xD;
      effective for helping individuals with MS gain more control over fatigue. Additionally, it&#xD;
      will explore the mechanisms of these two approaches to hypnosis treatment to determine which&#xD;
      might be most helpful to individuals with MS and fatigue.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 27, 2020</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</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>
    <intervention_model_description>Single-center, single-blind three-group randomized (1:1:1) controlled trial (RCT) comparing two hypnosis interventions to waitlist control efficacy for MS-related fatigue.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Research assistant administering the telephone assessments is blinded to participant treatment intervention while the clinician conducting the treatment sessions is blinded to participant responses provided during telephone assessments. The only instance where we may unblind staff members to assessment or treatment data (depending on what the staff member is responsible for) will be at the end of the study, after data collection has been completed. At that point, the staff member conducting telephone assessments may be allowed to know which interventions participants were assigned to, and the clinician conducting treatment sessions may be allowed to access assessment data if a staff member were to assist in data cleaning or data analysis. Participants are blind to study hypotheses and will not be told which intervention is expected to yield what results. Participants may be unblinded if/when we disseminate findings (e.g., in a published manuscript) related to this study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Fatigue Self Efficacy</measure>
    <time_frame>Assessed via telephone within a 1-week period at baseline (prior to randomization)</time_frame>
    <description>Multiple Sclerosis-Fatigue Self-Efficacy scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue Self Efficacy</measure>
    <time_frame>Third week: mid-treatment (after second session)</time_frame>
    <description>Multiple Sclerosis-Fatigue Self-Efficacy scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue Self Efficacy</measure>
    <time_frame>Fifth week: post-treatment (after fourth session)</time_frame>
    <description>Multiple Sclerosis-Fatigue Self-Efficacy scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue Self Efficacy</measure>
    <time_frame>4 months: 3 month follow-up</time_frame>
    <description>Multiple Sclerosis-Fatigue Self-Efficacy scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue Severity</measure>
    <time_frame>Assessed via telephone within a 1-week period at baseline (prior to randomization)</time_frame>
    <description>Fatigue Severity Scale (FSS) score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue Severity</measure>
    <time_frame>Third week: mid-treatment (after second session)</time_frame>
    <description>Fatigue Severity Scale (FSS) score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue Severity</measure>
    <time_frame>Fifth week: post-treatment (after fourth session)</time_frame>
    <description>Fatigue Severity Scale (FSS) score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue Severity</measure>
    <time_frame>4 months: 3 month follow-up</time_frame>
    <description>Fatigue Severity Scale (FSS) score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Psychological and Physical Function</measure>
    <time_frame>Assessed via telephone within a 1-week period at baseline (prior to randomization)</time_frame>
    <description>PROMIS Physical Function SF score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological and Physical Function</measure>
    <time_frame>Third week: mid-treatment (after second session)</time_frame>
    <description>PROMIS Physical Function SF score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological and Physical Function</measure>
    <time_frame>Fifth week: post-treatment (after fourth session)</time_frame>
    <description>PROMIS Physical Function SF score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological and Physical Function</measure>
    <time_frame>4 months: 3 month follow-up</time_frame>
    <description>PROMIS Physical Function SF score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity Level</measure>
    <time_frame>Assessed via telephone within a 1-week period at baseline (prior to randomization)</time_frame>
    <description>IPAQ: International Physical Activity Questionnaire SF score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity Level</measure>
    <time_frame>Third week: mid-treatment (after second session)</time_frame>
    <description>IPAQ: International Physical Activity Questionnaire SF score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity Level</measure>
    <time_frame>Fifth week: post-treatment (after fourth session)</time_frame>
    <description>IPAQ: International Physical Activity Questionnaire SF score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity Level</measure>
    <time_frame>4 months: 3 month follow-up</time_frame>
    <description>IPAQ: International Physical Activity Questionnaire SF score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Suggestibility</measure>
    <time_frame>Within a 1-week period at baseline (prior to randomization)</time_frame>
    <description>Barber Suggestibility Scale score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Suggestibility</measure>
    <time_frame>Fifth week: post-treatment (after fourth session)</time_frame>
    <description>Barber Suggestibility Scale score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attitudes towards hypnosis</measure>
    <time_frame>Assessed via telephone within a 1-week period at baseline (prior to randomization)</time_frame>
    <description>Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attitudes towards hypnosis</measure>
    <time_frame>Third week: mid-treatment (after second session)</time_frame>
    <description>Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attitudes towards hypnosis</measure>
    <time_frame>Fifth week: post-treatment (after fourth session)</time_frame>
    <description>Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attitudes towards hypnosis</measure>
    <time_frame>4 months: 3 month follow-up</time_frame>
    <description>Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Outcome Expectancy</measure>
    <time_frame>Assessed via telephone within a 1-week period at baseline (prior to randomization)</time_frame>
    <description>Treatment Expectancy Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>Assessed via telephone within a 1-week period at baseline (prior to randomization)</time_frame>
    <description>PROMIS-SLEEP DISTURBANCE - SF 8A</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>Third week: mid-treatment (after second session)</time_frame>
    <description>PROMIS-SLEEP DISTURBANCE - SF 8A</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>Fifth week: post-treatment (after fourth session)</time_frame>
    <description>PROMIS-SLEEP DISTURBANCE - SF 8A</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>4 months: 3 month follow-up</time_frame>
    <description>PROMIS-SLEEP DISTURBANCE - SF 8A</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Illness Perception</measure>
    <time_frame>Assessed via telephone within a 1-week period at baseline (prior to randomization)</time_frame>
    <description>Illness Perception Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Illness Perception</measure>
    <time_frame>Third week: mid-treatment (after second session)</time_frame>
    <description>Illness Perception Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Illness Perception</measure>
    <time_frame>Fifth week: post-treatment (after fourth session)</time_frame>
    <description>Illness Perception Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Illness Perception</measure>
    <time_frame>4 months: 3 month follow-up</time_frame>
    <description>Illness Perception Questionnaire</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Medication use for Fatigue</measure>
    <time_frame>Assessed via telephone within a 1-week period at baseline (prior to randomization)</time_frame>
    <description>CO-VARIATE - Medication self-report</description>
  </other_outcome>
  <other_outcome>
    <measure>Medication use for Fatigue</measure>
    <time_frame>Third week: mid-treatment (after second session)</time_frame>
    <description>CO-VARIATE - Medication self-report</description>
  </other_outcome>
  <other_outcome>
    <measure>Medication use for Fatigue</measure>
    <time_frame>Fifth week: post-treatment (after fourth session)</time_frame>
    <description>CO-VARIATE - Medication self-report</description>
  </other_outcome>
  <other_outcome>
    <measure>Medication use for Fatigue</measure>
    <time_frame>4 months: 3 month follow-up</time_frame>
    <description>CO-VARIATE - Medication self-report</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Active-Alert Hypnosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional Hypnosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-List Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in this arm will continue their usual care for fatigue. The therapist will notify participants assigned to Usual Care via the participant's preferred mode of communication (phone, U.S. mail, or email). People assigned to usual care will be encouraged to continue using the health care services available to them to address their fatigue. The study therapist will emphasize the importance of completing the outcome assessments. Following the completion of their final assessment (3 month follow-up); these individuals will be offered their choice of the two hypnosis treatments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active-Alert Hypnosis</intervention_name>
    <description>Participants in this arm will receive four one-hour weekly sessions that will include training in a rapid self-hypnosis method. Participants will learn how to use waking hypnosis to manage fatigue using exercises with sensory experiences.</description>
    <arm_group_label>Active-Alert Hypnosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Traditional Hypnosis</intervention_name>
    <description>Participants in this arm will receive four one-hour weekly sessions where participants will learn how to use hypnosis along with relaxation. The exercises and suggestions included in the training will be adapted from the protocol used in a series of studies on the efficacy of self-hypnosis training for the management of chronic pain in persons with disabilities, and from a therapist guide of procedures and hypnotic suggestions for chronic pain.</description>
    <arm_group_label>Traditional Hypnosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of MS;&#xD;
&#xD;
          -  Adults 18 years of age or older;&#xD;
&#xD;
          -  Bothersome fatigue (defined as the presence of chronic, problematic fatigue that, in&#xD;
             the opinion of the patient, has interfered with their daily activities for ≥ 3 months&#xD;
             and average Fatigue Severity Scale score &gt; to 4 at screening);&#xD;
&#xD;
          -  Ability to read, speak, and understand English and/or Spanish.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria will be evidence for significant psychopathology that would&#xD;
             interfere with study participation, including current suicidal ideation with intent,&#xD;
             active psychosis or hallucinations, or severe cognitive impairment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>M. Elena Mendoza, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>May 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>April 29, 2021</last_update_submitted>
  <last_update_submitted_qc>April 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>M. Elena Mendoza</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</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/NCT04429789
org study id: STUDY00007428
secondary id: PP-1904-33857
nct id: NCT04429789
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The proposed study is a single-center, single-blind three-group randomized (1:1:1) controlled
      trial (RCT) comparing two hypnosis interventions to waitlist control efficacy for MS-related
      fatigue.
This project will test the efficacy of two different hypnosis approaches for improving
      MS-related fatigue that have shown to be beneficial for individuals with cancer and other
      medical conditions in the management of their symptoms. One of these methods, the
      active-alert hypnosis has helped people to manage fatigue and may have important advantages
      over the more traditional relaxation hypnotic approaches in the treatment of fatigue, since
      the hypnotic inductions and the self-hypnosis methods use activation instead of relaxation.
      Therefore, the goals of this study are to determine if a comparison study of these two
      hypnotic conditions is feasible, and, if so, to determine which treatment may be more
      effective for helping individuals with MS gain more control over fatigue. Additionally, it
      will explore the mechanisms of these two approaches to hypnosis treatment to determine which
      might be most helpful to individuals with MS and fatigue.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Single-center, single-blind three-group randomized (1:1:1) controlled trial (RCT) comparing two hypnosis interventions to waitlist control efficacy for MS-related fatigue.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Research assistant administering the telephone assessments is blinded to participant treatment intervention while the clinician conducting the treatment sessions is blinded to participant responses provided during telephone assessments. The only instance where we may unblind staff members to assessment or treatment data (depending on what the staff member is responsible for) will be at the end of the study, after data collection has been completed. At that point, the staff member conducting telephone assessments may be allowed to know which interventions participants were assigned to, and the clinician conducting treatment sessions may be allowed to access assessment data if a staff member were to assist in data cleaning or data analysis. Participants are blind to study hypotheses and will not be told which intervention is expected to yield what results. Participants may be unblinded if/when we disseminate findings (e.g., in a published manuscript) related to this study.
measure: Fatigue Self Efficacy
time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
description: Multiple Sclerosis-Fatigue Self-Efficacy scale
measure: Fatigue Self Efficacy
time frame: Third week: mid-treatment (after second session)
description: Multiple Sclerosis-Fatigue Self-Efficacy scale
measure: Fatigue Self Efficacy
time frame: Fifth week: post-treatment (after fourth session)
description: Multiple Sclerosis-Fatigue Self-Efficacy scale
measure: Fatigue Self Efficacy
time frame: 4 months: 3 month follow-up
description: Multiple Sclerosis-Fatigue Self-Efficacy scale
measure: Fatigue Severity
time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
description: Fatigue Severity Scale (FSS) score
measure: Fatigue Severity
time frame: Third week: mid-treatment (after second session)
description: Fatigue Severity Scale (FSS) score
measure: Fatigue Severity
time frame: Fifth week: post-treatment (after fourth session)
description: Fatigue Severity Scale (FSS) score
measure: Fatigue Severity
time frame: 4 months: 3 month follow-up
description: Fatigue Severity Scale (FSS) score
measure: Psychological and Physical Function
time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
description: PROMIS Physical Function SF score
measure: Psychological and Physical Function
time frame: Third week: mid-treatment (after second session)
description: PROMIS Physical Function SF score
measure: Psychological and Physical Function
time frame: Fifth week: post-treatment (after fourth session)
description: PROMIS Physical Function SF score
measure: Psychological and Physical Function
time frame: 4 months: 3 month follow-up
description: PROMIS Physical Function SF score
measure: Activity Level
time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
description: IPAQ: International Physical Activity Questionnaire SF score
measure: Activity Level
time frame: Third week: mid-treatment (after second session)
description: IPAQ: International Physical Activity Questionnaire SF score
measure: Activity Level
time frame: Fifth week: post-treatment (after fourth session)
description: IPAQ: International Physical Activity Questionnaire SF score
measure: Activity Level
time frame: 4 months: 3 month follow-up
description: IPAQ: International Physical Activity Questionnaire SF score
measure: Suggestibility
time frame: Within a 1-week period at baseline (prior to randomization)
description: Barber Suggestibility Scale score
measure: Suggestibility
time frame: Fifth week: post-treatment (after fourth session)
description: Barber Suggestibility Scale score
measure: Attitudes towards hypnosis
time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
description: Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version
measure: Attitudes towards hypnosis
time frame: Third week: mid-treatment (after second session)
description: Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version
measure: Attitudes towards hypnosis
time frame: Fifth week: post-treatment (after fourth session)
description: Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version
measure: Attitudes towards hypnosis
time frame: 4 months: 3 month follow-up
description: Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version
measure: Treatment Outcome Expectancy
time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
description: Treatment Expectancy Scale
measure: Sleep Quality
time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
description: PROMIS-SLEEP DISTURBANCE - SF 8A
measure: Sleep Quality
time frame: Third week: mid-treatment (after second session)
description: PROMIS-SLEEP DISTURBANCE - SF 8A
measure: Sleep Quality
time frame: Fifth week: post-treatment (after fourth session)
description: PROMIS-SLEEP DISTURBANCE - SF 8A
measure: Sleep Quality
time frame: 4 months: 3 month follow-up
description: PROMIS-SLEEP DISTURBANCE - SF 8A
measure: Illness Perception
time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
description: Illness Perception Questionnaire
measure: Illness Perception
time frame: Third week: mid-treatment (after second session)
description: Illness Perception Questionnaire
measure: Illness Perception
time frame: Fifth week: post-treatment (after fourth session)
description: Illness Perception Questionnaire
measure: Illness Perception
time frame: 4 months: 3 month follow-up
description: Illness Perception Questionnaire
measure: Medication use for Fatigue
time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
description: CO-VARIATE - Medication self-report
measure: Medication use for Fatigue
time frame: Third week: mid-treatment (after second session)
description: CO-VARIATE - Medication self-report
measure: Medication use for Fatigue
time frame: Fifth week: post-treatment (after fourth session)
description: CO-VARIATE - Medication self-report
measure: Medication use for Fatigue
time frame: 4 months: 3 month follow-up
description: CO-VARIATE - Medication self-report
arm group label: Active-Alert Hypnosis
arm group type: Experimental
arm group label: Traditional Hypnosis
arm group type: Experimental
arm group label: Wait-List Control
arm group type: No Intervention
description: Participants in this arm will continue their usual care for fatigue. The therapist will notify participants assigned to Usual Care via the participant's preferred mode of communication (phone, U.S. mail, or email). People assigned to usual care will be encouraged to continue using the health care services available to them to address their fatigue. The study therapist will emphasize the importance of completing the outcome assessments. Following the completion of their final assessment (3 month follow-up); these individuals will be offered their choice of the two hypnosis treatments.
intervention type: Behavioral
intervention name: Active-Alert Hypnosis
description: Participants in this arm will receive four one-hour weekly sessions that will include training in a rapid self-hypnosis method. Participants will learn how to use waking hypnosis to manage fatigue using exercises with sensory experiences.
arm group label: Active-Alert Hypnosis
intervention type: Behavioral
intervention name: Traditional Hypnosis
description: Participants in this arm will receive four one-hour weekly sessions where participants will learn how to use hypnosis along with relaxation. The exercises and suggestions included in the training will be adapted from the protocol used in a series of studies on the efficacy of self-hypnosis training for the management of chronic pain in persons with disabilities, and from a therapist guide of procedures and hypnotic suggestions for chronic pain.
arm group label: Traditional Hypnosis
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: M. Elena Mendoza, PhD
role: Principal Investigator
affiliation: University of Washington
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: M. Elena Mendoza
investigator title: Principal Investigator
mesh term: Multiple Sclerosis