Trial Outcomes & Findings for Measurement and Modification of Threat Interpretation Bias in Neurodegenerative Movement Disorders (Aims 2 & 3) (NCT NCT05126862)
NCT ID: NCT05126862
Last Updated: 2024-12-20
Results Overview
Proportion of participants completing at least 50% of the MindTrails sessions (defined as proportion of participants who completed outcome assessments for at least 2 of the 3 timepoints measured during the intervention: baseline, week 3, and week 5)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
Between baseline and week 5
Results posted on
2024-12-20
Participant Flow
Participant milestones
| Measure |
Experimental: MindTrails Pilot in Parkinson's Disease
This intervention involves completion of five, 20-minute MindTrails online training sessions over five weeks.
|
Experimental: MindTrails Pilot in Huntington's Disease
This intervention involves completion of five, 20-minute MindTrails online training sessions over five weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
21
|
|
Overall Study
COMPLETED
|
14
|
12
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Measurement and Modification of Threat Interpretation Bias in Neurodegenerative Movement Disorders (Aims 2 & 3)
Baseline characteristics by cohort
| Measure |
Experimental: MindTrails Pilot in Parkinson's Disease
n=22 Participants
This intervention involves completion of five, 20-minute MindTrails online training sessions over five weeks.
|
Experimental: MindTrails Pilot in Huntington's Disease
n=21 Participants
This intervention involves completion of five, 20-minute MindTrails online training sessions over five weeks.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.05 years
STANDARD_DEVIATION 11.20 • n=5 Participants
|
48.95 years
STANDARD_DEVIATION 11.81 • n=7 Participants
|
56.67 years
STANDARD_DEVIATION 13.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
21 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Education
High School
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Education
Some College
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Education
Associate's Degree
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Education
Bachelor's
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Education
Master's
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Education
Doctorate/PhD
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Between baseline and week 5Proportion of participants completing at least 50% of the MindTrails sessions (defined as proportion of participants who completed outcome assessments for at least 2 of the 3 timepoints measured during the intervention: baseline, week 3, and week 5)
Outcome measures
| Measure |
Experimental: MindTrails Pilot in Parkinson's Disease
n=22 Participants
This intervention involves completion of five, 20-minute MindTrails online training sessions over five weeks.
|
Experimental: MindTrails Pilot in Huntington's Disease
n=21 Participants
This intervention involves completion of five, 20-minute MindTrails online training sessions over five weeks.
|
|---|---|---|
|
Proportion of Participants Completing at Least 50% of the MindTrails Sessions
|
14 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: After completion of the intervention (week 5)Population: All participants in each arm were invited to complete a semi-structured interview; 14 PD participants and 10 HD participants completed interviews.
All participants in each arm were invited to complete a semi-structured interview to assess their experience with the intervention or barriers to beginning or completing the intervention. Interviews were transcribed, and separate codebooks were developed for PD and HD transcripts. Each transcript was coded by 2 coders, and any disagreements were resolved by a third coder. Frequency of overlapping codes under the "Experiences completing MindTrails" theme for each group (PD and HD) are reported here.
Outcome measures
| Measure |
Experimental: MindTrails Pilot in Parkinson's Disease
n=14 Participants
This intervention involves completion of five, 20-minute MindTrails online training sessions over five weeks.
|
Experimental: MindTrails Pilot in Huntington's Disease
n=10 Participants
This intervention involves completion of five, 20-minute MindTrails online training sessions over five weeks.
|
|---|---|---|
|
Participant Perceptions of Perceived Benefits and Limitations of MindTrails
did not need help to complete
|
12 Participants
|
9 Participants
|
|
Participant Perceptions of Perceived Benefits and Limitations of MindTrails
needed caregiver assistance
|
1 Participants
|
1 Participants
|
|
Participant Perceptions of Perceived Benefits and Limitations of MindTrails
completed it on phone
|
3 Participants
|
1 Participants
|
|
Participant Perceptions of Perceived Benefits and Limitations of MindTrails
completed on computer
|
3 Participants
|
3 Participants
|
|
Participant Perceptions of Perceived Benefits and Limitations of MindTrails
participant baseline characteristics influence experience positively
|
4 Participants
|
4 Participants
|
|
Participant Perceptions of Perceived Benefits and Limitations of MindTrails
participant baseline characteristics influence experience negatively
|
4 Participants
|
5 Participants
|
|
Participant Perceptions of Perceived Benefits and Limitations of MindTrails
positive experience/ enjoyed MindTrails
|
7 Participants
|
4 Participants
|
|
Participant Perceptions of Perceived Benefits and Limitations of MindTrails
easy to navigate/ straight-forward
|
13 Participants
|
10 Participants
|
|
Participant Perceptions of Perceived Benefits and Limitations of MindTrails
interesting/ engaging
|
5 Participants
|
2 Participants
|
|
Participant Perceptions of Perceived Benefits and Limitations of MindTrails
neutral experience with MindTrails
|
2 Participants
|
2 Participants
|
|
Participant Perceptions of Perceived Benefits and Limitations of MindTrails
did not enjoy MindTrails
|
0 Participants
|
1 Participants
|
|
Participant Perceptions of Perceived Benefits and Limitations of MindTrails
difficulty with and/or did not like forced response choice
|
5 Participants
|
3 Participants
|
|
Participant Perceptions of Perceived Benefits and Limitations of MindTrails
redundancy
|
4 Participants
|
2 Participants
|
Adverse Events
Experimental: MindTrails Pilot in Parkinson's Disease
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental: MindTrails Pilot in Huntington's Disease
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jessie Gibson, PhD, RN
University of Virginia School of Nursing
Phone: 434-924-0107
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place