NCT07427433

Brief Summary

The goal of this study is to compare a lifestyle intervention and a mind-body intervention against a wait-list control in individuals with multiple sclerosis experiencing persistent symptoms. Our research questions include: Are lifestyle and mind-body interventions additive to usual care in MS? Can these interventions improve MS symptoms and overall quality of life?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 16, 2026

Last Update Submit

February 16, 2026

Conditions

Multiple Sclerosis

Keywords

Amygdala and Insula Retraining (AIR)

Outcome Measures

Primary Outcomes (1)

  • Fatigue Severity Scale

    Baseline (Week 0) to post-intervention (Week 12)

Secondary Outcomes (5)

  • PROMIS Pain Interference 8a

    Baseline (Week 0) to post-intervention (Week 12)

  • EQ-5D (quality of life)

    Baseline (Week 0) to post-intervention (Week 12)

  • GAD-7 (anxiety)

    Baseline (Week 0) to post-intervention (Week 12)

  • PHQ-9 (depression, with suicidality item excluded)

    Baseline (Week 0) to post-intervention (Week 12)

  • MSQ-Revised (exploratory)

    Baseline (Week 0) to post-intervention (Week 12)

Study Arms (3)

Amygdala insula retraining

EXPERIMENTAL

Mind body amygdala insula retraining intervention delivered virtually + usual care

Behavioral: Amygdala insula retraining

Lifestyle program

EXPERIMENTAL

Mind body lifestyle intervention

Behavioral: Lifestyle program

Control

NO INTERVENTION

Interventions

Amygdala insula retrainingBEHAVIORAL

Mind body brain retraining intervention

Amygdala insula retraining
Lifestyle programBEHAVIORAL

Mind body lifestyle intervention

Lifestyle program

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed multiple sclerosis diagnosis

You may not qualify if:

  • Previous experience with brain retaining programs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luther College Department of Psychology

Decorah, Iowa, 52101, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2026

First Posted

February 23, 2026

Study Start

September 15, 2024

Primary Completion

March 15, 2025

Study Completion

March 15, 2025

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)