Multiple SclerosisPOWER-UPNCT04429789
Waking Hypnosis in the Treatment of MS-related Fatigue
A study testing Active-Alert Hypnosis and Traditional Hypnosis in people with Multiple Sclerosis, run by University of Washington at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Active-Alert Hypnosis and Traditional Hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2020to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of MS;
- Adults 18 years of age or older;
- Bothersome fatigue (defined as the presence of chronic, problematic fatigue that, in the opinion of the patient, has interfered with their daily activities for ≥ 3 months and average Fatigue Severity Scale score > to 4 at screening);
- Ability to read, speak, and understand English and/or Spanish.
Who cannot join
- Exclusion criteria will be evidence for significant psychopathology that would interfere with study participation, including current suicidal ideation with intent, active psychosis or hallucinations, or severe cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Waking Hypnosis in the Treatment of MS-related Fatigue: Pilot and Feasibility Study
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.
Read the detailed description
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Active-Alert Hypnosis, Traditional Hypnosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active-Alert HypnosisBehavioural
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.
Traditional HypnosisBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active-Alert Hypnosis | Experimental | Not described Receives: Behavioral: Active-Alert Hypnosis |
| Traditional Hypnosis | Experimental | Not described Receives: Behavioral: Traditional Hypnosis |
| Wait-List Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Self Efficacy
Multiple Sclerosis-Fatigue Self-Efficacy scale
Measured: Assessed via telephone within a 1-week period at baseline (prior to randomization)
Fatigue Self Efficacy
Multiple Sclerosis-Fatigue Self-Efficacy scale
Measured: Third week: mid-treatment (after second session)
Fatigue Self Efficacy
Multiple Sclerosis-Fatigue Self-Efficacy scale
Measured: Fifth week: post-treatment (after fourth session)
Fatigue Self Efficacy
Multiple Sclerosis-Fatigue Self-Efficacy scale
Measured: 4 months: 3 month follow-up
Fatigue Severity
Fatigue Severity Scale (FSS) score
Measured: Assessed via telephone within a 1-week period at baseline (prior to randomization)
Fatigue Severity
Fatigue Severity Scale (FSS) score
Measured: Third week: mid-treatment (after second session)
Fatigue Severity
Fatigue Severity Scale (FSS) score
Measured: Fifth week: post-treatment (after fourth session)
Fatigue Severity
Fatigue Severity Scale (FSS) score
Measured: 4 months: 3 month follow-up
Secondary outcomes (23)
Psychological and Physical Function
PROMIS Physical Function SF score
Measured: Assessed via telephone within a 1-week period at baseline (prior to randomization)
Psychological and Physical Function
PROMIS Physical Function SF score
Measured: Third week: mid-treatment (after second session)
Psychological and Physical Function
PROMIS Physical Function SF score
Measured: Fifth week: post-treatment (after fourth session)
Psychological and Physical Function
PROMIS Physical Function SF score
Measured: 4 months: 3 month follow-up
Activity Level
IPAQ: International Physical Activity Questionnaire SF score
Measured: Assessed via telephone within a 1-week period at baseline (prior to randomization)
Activity Level
IPAQ: International Physical Activity Questionnaire SF score
Measured: Third week: mid-treatment (after second session)
Activity Level
IPAQ: International Physical Activity Questionnaire SF score
Measured: Fifth week: post-treatment (after fourth session)
Activity Level
IPAQ: International Physical Activity Questionnaire SF score
Measured: 4 months: 3 month follow-up
Suggestibility
Barber Suggestibility Scale score
Measured: Within a 1-week period at baseline (prior to randomization)
Suggestibility
Barber Suggestibility Scale score
Measured: Fifth week: post-treatment (after fourth session)
Attitudes towards hypnosis
Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version
Measured: Assessed via telephone within a 1-week period at baseline (prior to randomization)
Attitudes towards hypnosis
Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version
Measured: Third week: mid-treatment (after second session)
Attitudes towards hypnosis
Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version
Measured: Fifth week: post-treatment (after fourth session)
Attitudes towards hypnosis
Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version
Measured: 4 months: 3 month follow-up
Treatment Outcome Expectancy
Treatment Expectancy Scale
Measured: Assessed via telephone within a 1-week period at baseline (prior to randomization)
Sleep Quality
PROMIS-SLEEP DISTURBANCE - SF 8A
Measured: Assessed via telephone within a 1-week period at baseline (prior to randomization)
Sleep Quality
PROMIS-SLEEP DISTURBANCE - SF 8A
Measured: Third week: mid-treatment (after second session)
Sleep Quality
PROMIS-SLEEP DISTURBANCE - SF 8A
Measured: Fifth week: post-treatment (after fourth session)
Sleep Quality
PROMIS-SLEEP DISTURBANCE - SF 8A
Measured: 4 months: 3 month follow-up
Illness Perception
Illness Perception Questionnaire
Measured: Assessed via telephone within a 1-week period at baseline (prior to randomization)
Illness Perception
Illness Perception Questionnaire
Measured: Third week: mid-treatment (after second session)
Illness Perception
Illness Perception Questionnaire
Measured: Fifth week: post-treatment (after fourth session)
Illness Perception
Illness Perception Questionnaire
Measured: 4 months: 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start27 May 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Principal investigator, M. Elena Mendoza, University of Washington
- Investigators
- M. Elena Mendoza, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429789
- Sponsor's protocol ID
- STUDY00007428
- Other IDs
- PP-1904-33857
- Acronym
- POWER-UP
- Status last verified
- Apr 2021
- First submitted
- 11 May 2020
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Waking Hypnosis in the Treatment of MS-related Fatigue: Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT04429789
- Acronym / sponsor ID
- POWER-UP / STUDY00007428
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- 27 May 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active-Alert Hypnosis | Experimental | Behavioral: Active-Alert Hypnosis |
| Traditional Hypnosis | Experimental | Behavioral: Traditional Hypnosis |
| Wait-List Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of MS;
- Adults 18 years of age or older;
- Bothersome fatigue (defined as the presence of chronic, problematic fatigue that, in the opinion of the patient, has interfered with their daily activities for ≥ 3 months and average Fatigue Severity Scale score > to 4 at screening);
- Ability to read, speak, and understand English and/or Spanish.
Key exclusion criteria (1 listed)
- Exclusion criteria will be evidence for significant psychopathology that would interfere with study participation, including current suicidal ideation with intent, active psychosis or hallucinations, or severe cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active-Alert HypnosisParticipants 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. | Behavioural | Active-Alert Hypnosis |
| Traditional HypnosisParticipants 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. | Behavioural | Traditional Hypnosis |
Primary outcome
Fatigue Self Efficacy
Time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
Multiple Sclerosis-Fatigue Self-Efficacy scale
Fatigue Self Efficacy
Time frame: Third week: mid-treatment (after second session)
Multiple Sclerosis-Fatigue Self-Efficacy scale
Fatigue Self Efficacy
Time frame: Fifth week: post-treatment (after fourth session)
Multiple Sclerosis-Fatigue Self-Efficacy scale
Fatigue Self Efficacy
Time frame: 4 months: 3 month follow-up
Multiple Sclerosis-Fatigue Self-Efficacy scale
Fatigue Severity
Time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
Fatigue Severity Scale (FSS) score
Fatigue Severity
Time frame: Third week: mid-treatment (after second session)
Fatigue Severity Scale (FSS) score
Fatigue Severity
Time frame: Fifth week: post-treatment (after fourth session)
Fatigue Severity Scale (FSS) score
Fatigue Severity
Time frame: 4 months: 3 month follow-up
Fatigue Severity Scale (FSS) score
23 secondary outcomes
Psychological and Physical Function
Time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
Psychological and Physical Function
Time frame: Third week: mid-treatment (after second session)
Psychological and Physical Function
Time frame: Fifth week: post-treatment (after fourth session)
Psychological and Physical Function
Time frame: 4 months: 3 month follow-up
Activity Level
Time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
Activity Level
Time frame: Third week: mid-treatment (after second session)
Activity Level
Time frame: Fifth week: post-treatment (after fourth session)
Activity Level
Time frame: 4 months: 3 month follow-up
Suggestibility
Time frame: Within a 1-week period at baseline (prior to randomization)
Suggestibility
Time frame: Fifth week: post-treatment (after fourth session)
Attitudes towards hypnosis
Time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
Attitudes towards hypnosis
Time frame: Third week: mid-treatment (after second session)
Attitudes towards hypnosis
Time frame: Fifth week: post-treatment (after fourth session)
Attitudes towards hypnosis
Time frame: 4 months: 3 month follow-up
Treatment Outcome Expectancy
Time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
Sleep Quality
Time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
Sleep Quality
Time frame: Third week: mid-treatment (after second session)
Sleep Quality
Time frame: Fifth week: post-treatment (after fourth session)
Sleep Quality
Time frame: 4 months: 3 month follow-up
Illness Perception
Time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
Illness Perception
Time frame: Third week: mid-treatment (after second session)
Illness Perception
Time frame: Fifth week: post-treatment (after fourth session)
Illness Perception
Time frame: 4 months: 3 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Elena Mendoza, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active-Alert Hypnosis and Traditional Hypnosis in people with Multiple Sclerosis, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Self Efficacy (time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.