Waking Hypnosis in the Treatment of MS-related Fatigue

NCT04429789 | Completed

• 2 other identifiers: STUDY00007428PP-1904-33857
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (8)

• 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

  4 months: 3 month follow-up

Secondary Outcomes (23)

• Psychological and Physical Function

  Assessed via telephone within a 1-week period at baseline (prior to randomization)

• Psychological and Physical Function

  Third week: mid-treatment (after second session)

• Psychological and Physical Function

  Fifth week: post-treatment (after fourth session)

• Psychological and Physical Function

  4 months: 3 month follow-up

• Activity Level

  Assessed via telephone within a 1-week period at baseline (prior to randomization)

Other Outcomes (4)

• Medication use for Fatigue

  Assessed via telephone within a 1-week period at baseline (prior to randomization)

• Medication use for Fatigue

  Third week: mid-treatment (after second session)

• Medication use for Fatigue

  Fifth week: post-treatment (after fourth session)

Study Arms (3)

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.

Interventions

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.

Active-Alert Hypnosis

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.

Traditional Hypnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• M. Elena Mendoza, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: June 12, 2020
• Study Start: May 27, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: May 3, 2021

Record last verified: 2021-04

Locations

US (1)