Multiple Sclerosis
Conditions
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.
Interventions
BEHAVIORALActive-Alert Hypnosis
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.
BEHAVIORALTraditional Hypnosis
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.
Sponsors
National Multiple Sclerosis Society
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Severity | Assessed via telephone within a 1-week period at baseline (prior to randomization) | Fatigue Severity Scale (FSS) score |
| Fatigue Self Efficacy | Assessed via telephone within a 1-week period at baseline (prior to randomization) | Multiple Sclerosis-Fatigue Self-Efficacy scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activity Level | Assessed via telephone within a 1-week period at baseline (prior to randomization) | IPAQ: International Physical Activity Questionnaire SF score |
| Suggestibility | Within a 1-week period at baseline (prior to randomization) | Barber Suggestibility Scale score |
| Attitudes towards hypnosis | Assessed via telephone within a 1-week period at baseline (prior to randomization) | Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version |
| Sleep Quality | Assessed via telephone within a 1-week period at baseline (prior to randomization) | PROMIS-SLEEP DISTURBANCE - SF 8A |
| Illness Perception | Assessed via telephone within a 1-week period at baseline (prior to randomization) | Illness Perception Questionnaire |
| Treatment Outcome Expectancy | Assessed via telephone within a 1-week period at baseline (prior to randomization) | Treatment Expectancy Scale |
| Psychological and Physical Function | Assessed via telephone within a 1-week period at baseline (prior to randomization) | PROMIS Physical Function SF score |
Other
| Measure | Time frame | Description |
|---|---|---|
| Medication use for Fatigue | Assessed via telephone within a 1-week period at baseline (prior to randomization) | CO-VARIATE - Medication self-report |
Countries
United States
Outcome results
None listed