Clinical trial NCT04429789: Waking Hypnosis in the Treatment of MS-related Fatigue
Official title: Waking Hypnosis in the Treatment of MS-related Fatigue: Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2020-06-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Fatigue Self Efficacy
timeFrame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
measure: Fatigue Self Efficacy
timeFrame: Third week: mid-treatment (after second session)
measure: Fatigue Self Efficacy
timeFrame: Fifth week: post-treatment (after fourth session)
measure: Fatigue Self Efficacy
timeFrame: 4 months: 3 month follow-up
measure: Fatigue Severity
timeFrame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
measure: Fatigue Severity
timeFrame: Third week: mid-treatment (after second session)
measure: Fatigue Severity
timeFrame: Fifth week: post-treatment (after fourth session)
measure: Fatigue Severity
timeFrame: 4 months: 3 month follow-up
Secondary outcomes:
measure: Psychological and Physical Function
timeFrame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
measure: Psychological and Physical Function
timeFrame: Third week: mid-treatment (after second session)
measure: Psychological and Physical Function
timeFrame: Fifth week: post-treatment (after fourth session)
measure: Psychological and Physical Function
timeFrame: 4 months: 3 month follow-up
measure: Activity Level
timeFrame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
measure: Activity Level
timeFrame: Third week: mid-treatment (after second session)
measure: Activity Level
timeFrame: Fifth week: post-treatment (after fourth session)
measure: Activity Level
timeFrame: 4 months: 3 month follow-up
measure: Suggestibility
timeFrame: Within a 1-week period at baseline (prior to randomization)
measure: Suggestibility
timeFrame: Fifth week: post-treatment (after fourth session)
measure: Attitudes towards hypnosis
timeFrame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
measure: Attitudes towards hypnosis
timeFrame: Third week: mid-treatment (after second session)
measure: Attitudes towards hypnosis
timeFrame: Fifth week: post-treatment (after fourth session)
measure: Attitudes towards hypnosis
timeFrame: 4 months: 3 month follow-up
measure: Treatment Outcome Expectancy
timeFrame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
measure: Sleep Quality
timeFrame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
measure: Sleep Quality
timeFrame: Third week: mid-treatment (after second session)
measure: Sleep Quality
timeFrame: Fifth week: post-treatment (after fourth session)
measure: Sleep Quality
timeFrame: 4 months: 3 month follow-up
measure: Illness Perception
timeFrame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
measure: Illness Perception
timeFrame: Third week: mid-treatment (after second session)
measure: Illness Perception
timeFrame: Fifth week: post-treatment (after fourth session)
measure: Illness Perception
timeFrame: 4 months: 3 month follow-up
Other outcomes:
measure: Medication use for Fatigue
timeFrame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
measure: Medication use for Fatigue
timeFrame: Third week: mid-treatment (after second session)
measure: Medication use for Fatigue
timeFrame: Fifth week: post-treatment (after fourth session)
measure: Medication use for Fatigue
timeFrame: 4 months: 3 month follow-up
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: M. Elena Mendoza, PhD
role: PRINCIPAL_INVESTIGATOR
References: