NCT07425431

Brief Summary

The goal of the study is to compare a mind body intervention against usual care in patients with fatigue with mold illness. Our research questions include:

  • Is the mind body intervention additive to usual care in mold illness
  • Can the mind body intervention change self-reported overall wellness, and wearable device metrics such as heart rate variability

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

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

February 15, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 16, 2026

Last Update Submit

February 16, 2026

Conditions

Mold Illness

Outcome Measures

Primary Outcomes (2)

  • Mold IQ Questionnaire

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

  • Heart Rate Variability

    HRV collected via wearable devices

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

Secondary Outcomes (4)

  • Hospital Anxiety and Depression Scale (HADS)

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

  • Multidimensional Fatigue Inventory (MFI)

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

  • PROMIS-29

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

  • EuroQol 5 Dimension (EQ-5D)

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

Study Arms (2)

Amygdala insula retraining + standard care

EXPERIMENTAL

Mind body intervention intervention delivered virtually

Behavioral: Amygdala insula retraining

Control

NO INTERVENTION

The participants in the comparator group will be wait listed for the intervention

Interventions

Amygdala insula retrainingBEHAVIORAL

Mind body intervention

Amygdala insula retraining + standard care

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18-80
  • Confirmed mold illness through a positive mold mycotoxin test from October 2023-January 2025 OR who are receiving active treatment for mold illness under the care of an MD or ND.
  • Able to speak English
  • Able to access internet

You may not qualify if:

  • \- Previous experience with brain retraining programs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luther College Department of Psychology

Decorah, Iowa, 52101, United States

Location

Study Design

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

Study Record Dates

First Submitted

February 16, 2026

First Posted

February 20, 2026

Study Start

February 15, 2025

Primary Completion

August 15, 2025

Study Completion

August 15, 2025

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)