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| ID | Type | Description | Link |
|---|---|---|---|
| PP-1904-33857 | Other Grant/Funding Number | National Multiple Sclerosis Society |
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| Name | Class |
|---|---|
| National Multiple Sclerosis Society | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active-Alert Hypnosis | Experimental |
| |
| Traditional Hypnosis | Experimental |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active-Alert Hypnosis | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Self Efficacy | Multiple Sclerosis-Fatigue Self-Efficacy scale | Assessed via telephone within a 1-week period at baseline (prior to randomization) |
| Fatigue Self Efficacy | Multiple Sclerosis-Fatigue Self-Efficacy scale | Third week: mid-treatment (after second session) |
| Fatigue Self Efficacy | Multiple Sclerosis-Fatigue Self-Efficacy scale | Fifth week: post-treatment (after fourth session) |
| Fatigue Self Efficacy | Multiple Sclerosis-Fatigue Self-Efficacy scale | 4 months: 3 month follow-up |
| Fatigue Severity | Fatigue Severity Scale (FSS) score | Assessed via telephone within a 1-week period at baseline (prior to randomization) |
| Fatigue Severity | Fatigue Severity Scale (FSS) score | Third week: mid-treatment (after second session) |
| Fatigue Severity | Fatigue Severity Scale (FSS) score | Fifth week: post-treatment (after fourth session) |
| Fatigue Severity | Fatigue Severity Scale (FSS) score |
| Measure | Description | Time Frame |
|---|---|---|
| Psychological and Physical Function | PROMIS Physical Function SF score | Assessed via telephone within a 1-week period at baseline (prior to randomization) |
| Psychological and Physical Function | PROMIS Physical Function SF score |
| Measure | Description | Time Frame |
|---|---|---|
| Medication use for Fatigue | CO-VARIATE - Medication self-report | Assessed via telephone within a 1-week period at baseline (prior to randomization) |
| Medication use for Fatigue | CO-VARIATE - Medication self-report |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M. Elena Mendoza, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98104 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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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.
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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.
| Traditional Hypnosis | Behavioral | 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. |
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| 4 months: 3 month follow-up |
| Third week: mid-treatment (after second session) |
| Psychological and Physical Function | PROMIS Physical Function SF score | Fifth week: post-treatment (after fourth session) |
| Psychological and Physical Function | PROMIS Physical Function SF score | 4 months: 3 month follow-up |
| Activity Level | IPAQ: International Physical Activity Questionnaire SF score | Assessed via telephone within a 1-week period at baseline (prior to randomization) |
| Activity Level | IPAQ: International Physical Activity Questionnaire SF score | Third week: mid-treatment (after second session) |
| Activity Level | IPAQ: International Physical Activity Questionnaire SF score | Fifth week: post-treatment (after fourth session) |
| Activity Level | IPAQ: International Physical Activity Questionnaire SF score | 4 months: 3 month follow-up |
| Suggestibility | Barber Suggestibility Scale score | Within a 1-week period at baseline (prior to randomization) |
| Suggestibility | Barber Suggestibility Scale score | Fifth week: post-treatment (after fourth session) |
| Attitudes towards hypnosis | Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version | 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 | Third week: mid-treatment (after second session) |
| Attitudes towards hypnosis | Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version | Fifth week: post-treatment (after fourth session) |
| Attitudes towards hypnosis | Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version | 4 months: 3 month follow-up |
| Treatment Outcome Expectancy | Treatment Expectancy Scale | Assessed via telephone within a 1-week period at baseline (prior to randomization) |
| Sleep Quality | PROMIS-SLEEP DISTURBANCE - SF 8A | Assessed via telephone within a 1-week period at baseline (prior to randomization) |
| Sleep Quality | PROMIS-SLEEP DISTURBANCE - SF 8A | Third week: mid-treatment (after second session) |
| Sleep Quality | PROMIS-SLEEP DISTURBANCE - SF 8A | Fifth week: post-treatment (after fourth session) |
| Sleep Quality | PROMIS-SLEEP DISTURBANCE - SF 8A | 4 months: 3 month follow-up |
| Illness Perception | Illness Perception Questionnaire | Assessed via telephone within a 1-week period at baseline (prior to randomization) |
| Illness Perception | Illness Perception Questionnaire | Third week: mid-treatment (after second session) |
| Illness Perception | Illness Perception Questionnaire | Fifth week: post-treatment (after fourth session) |
| Illness Perception | Illness Perception Questionnaire | 4 months: 3 month follow-up |
| Third week: mid-treatment (after second session) |
| Medication use for Fatigue | CO-VARIATE - Medication self-report | Fifth week: post-treatment (after fourth session) |
| Medication use for Fatigue | CO-VARIATE - Medication self-report | 4 months: 3 month follow-up |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |