Open-Label Placebos to Treat Fatigue in Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-17

Study Completion Date

2022-01-19

Brief Summary

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Fatigue is one of the most prevalent and disabling symptoms of multiple sclerosis. Current treatments, including pharmacological, physical therapy, sleep regulation and psychological interventions are of marginal benefit. Pharmacological treatments have inconsistent evidence. Recent studies show that non-deceptive open-label placebos (OLP) have moderate-to-large effects on symptoms, including fatigue, in adults with a variety of medical conditions.

Hence, this is a pilot and feasibility study to obtain data on the feasibility and effects of OLP for multiple sclerosis related fatigue and its impact to provide the basis for a competitive NIH application. This pilot study will be the first study to evaluate whether OLP, that garners full consent and engages patients in their wellness, may offer a safe, effective treatment for multiple sclerosis related fatigue.

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Detailed Description

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The purpose of this pilot study is to evaluate the feasibility of recruiting, enrolling and retaining participants in a study on the acceptability and effects of a non-deceptive (open-label) administration of placebo pills for treating MS related fatigue. Specific Aim 1 will assess the feasibility endpoints including accrual (enroll 44 participants), retention (80% of the sample) and placebo adherence (90%). Specific Aim 2 will evaluate the between-group changes in fatigue, quality of life, cognitive functioning and self-efficacy. Specific Aim 3 will evaluate participant acceptability, satisfaction and experience.

Design:

This pilot study is a randomized control trial consisting of three arms: open label placebo arm, expectancy arm, and usual care arm. The clinical coordinator will review medical records, enroll and consent participants based on the following inclusion criteria: diagnosis of MS, 19 years or older, report of moderate to severe fatigue, PDDS score of \< 7, and stable dose of DMTs for 90 days.

Exclusion criteria consists of: major comorbid conditions and use of off label medications or exercise programs in the past 30 days, and if one is confined to a wheelchair.

Baseline and 21 day tele assessments will involve objective measures performed by a physical therapist, Single Digit Modality Test (SDMT) and Five Time Sit to Stand (FTSST) and subjective questionnaires sent to participant's email including Modified Fatigue Impact Scale (MFIS), Functional Systems Score (FSS), Patient Reported Outcomes Measurement Information System (PROMIS), Perceived Deficits Questionnaire, Epworth Sleepiness Scale, and the SF-36 assess of quality of life. Participants will be randomized by the clinical coordinator after baseline testing. The open label placebo and expectancy arm will meet with the care provider who will follow a scripted orientation that mimics a typical patient-provider interaction when prescribing a medication, including the rationale for effectiveness. The provider will emphasize the importance of adherence to the medication for the open label placebo arm and the breathing exercises for the expectancy arm for the next 21 days. A tracking sheet will be provided to both arms to document adherence. The usual care arm will meet with the care provider who will follow a scripted orientation on fatigue and heat management strategies. All participants will receive educational materials on fatigue and heat management. A day 11 check in call will be made to gauge progress and answer questions. After the 21 day tele assessment is performed, the participant will complete subjective questionnaires via email for 28 day and 35 day follow up.

Conditions

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Multiple Sclerosis Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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OLP treatment

Participants randomized to the treatment group will receive: 1) educational materials; 2) positive expectancy; 3) 2 placebo pills twice a day for 21 days.

Group Type EXPERIMENTAL

OLP treatment

Intervention Type OTHER

Receive two open-label placebo pills twice a day after randomization. Will receive for 21 days and then stop. It will include educational materials and positive expectancy.

Usual care

Participants randomized to the no treatment group will remain in standard care alone for 21 days and receive educational materials.

Group Type OTHER

Usual care

Intervention Type OTHER

Remain in standard care after randomization and educational materials.

Expectancy Group

Participants receive educational materials and positive expectancy orientation via Zoom or telephone

Group Type ACTIVE_COMPARATOR

Expectancy Group

Intervention Type OTHER

Educational materials and positive expectancy orientation via Zoom or telephone

Interventions

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OLP treatment

Receive two open-label placebo pills twice a day after randomization. Will receive for 21 days and then stop. It will include educational materials and positive expectancy.

Intervention Type OTHER

Usual care

Remain in standard care after randomization and educational materials.

Intervention Type OTHER

Expectancy Group

Educational materials and positive expectancy orientation via Zoom or telephone

Intervention Type OTHER

Other Intervention Names

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Open-Label placebo Glucose Tablet Standard care Education

Eligibility Criteria

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Inclusion Criteria

* A diagnosis of MS
* Aged 19 years or older
* report moderate-to-severe fatigue (i.e., ≥4 on the FSS)
* Patient Determined Disease Steps score of ≥7.

Exclusion Criteria

* Major comorbid conditions that might influence fatigue (e.g. lupus, chronic fatigue syndrome)
* Patients treated with off label medications or exercise program in the past 30 days.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No