An interventional study of MindTrails in Huntington Disease and Parkinson Disease, sponsored by University of Virginia. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-12-20.
Sponsored by University of Virginia · Not applicable, Interventional, and Treatment
The purpose of this study is conduct a pilot open trial of a web-based cognitive bias modification intervention to reduce anxiety symptoms in persons with Huntington's disease and persons with Parkinson's disease.
After being informed about the study and giving informed consent, participants will enroll in a pilot open trial of MindTrails, a web-based cognitive bias modification intervention. Participants will complete five, 20-minute MindTrails training sessions over five weeks. Additionally, assessments of anxiety, interpretation bias, and other related outcomes will be completed at baseline, week 3, week 5, and 2 months following the last training session. Participants will each complete a semi-structured interview to provide qualitative feedback about their experiences with MindTrails and anxiety.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 43 is close to the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
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Exclusion Criteria:
This intervention involves completion of five, 20-minute MindTrails online training sessions over five weeks.
Behavioral: MindTrails
MindTrails is a web-based cognitive bias modification intervention. Training sessions are designed to encourage cognitive flexibility through repeated practice assigning benign resolutions to ambiguous, anxiety-provoking situations.
Proportion of Participants Completing at Least 50% of the MindTrails Sessions
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)
Time frame: Between baseline and week 5
Participant Perceptions of Perceived Benefits and Limitations of MindTrails
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.
Time frame: After completion of the intervention (week 5)
| Milestone | Experimental: MindTrails Pilot in Parkinson's Disease | Experimental: MindTrails Pilot in Huntington's Disease |
|---|---|---|
| Started | 22 | 21 |
| Completed | 14 | 12 |
| Not completed | 8 | 9 |
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)
| Participants | Experimental: MindTrails Pilot in Parkinson's Disease | Experimental: MindTrails Pilot in Huntington's Disease |
|---|---|---|
| Proportion of Participants Completing at Least 50% of the MindTrails Sessions | 14 | 14 |
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.
| Participants | Experimental: MindTrails Pilot in Parkinson's Disease | Experimental: MindTrails Pilot in Huntington's Disease |
|---|---|---|
| did not need help to complete | 12 | 9 |
| needed caregiver assistance | 1 | 1 |
| completed it on phone | 3 | 1 |
| completed on computer | 3 | 3 |
| participant baseline characteristics influence experience positively | 4 | 4 |
| participant baseline characteristics influence experience negatively | 4 | 5 |
| positive experience/ enjoyed MindTrails | 7 | 4 |
| easy to navigate/ straight-forward | 13 | 10 |
| interesting/ engaging | 5 | 2 |
| neutral experience with MindTrails | 2 | 2 |
| did not enjoy MindTrails | 0 | 1 |
| difficulty with and/or did not like forced response choice | 5 | 3 |
| redundancy | 4 | 2 |
Collected over Approximately 13 weeks (5 week intervention period and 2 month follow-up).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental: MindTrails Pilot in Parkinson's Disease | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Experimental: MindTrails Pilot in Huntington's Disease | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Age, Continuous(years) | Experimental: MindTrails Pilot in Parkinson's Disease | Experimental: MindTrails Pilot in Huntington's Disease | Total |
|---|---|---|---|
| Mean | 64.05 ± 11.20 | 48.95 ± 11.81 | 56.67 ± 13.69 |
| Sex: Female, Male(Participants) | Experimental: MindTrails Pilot in Parkinson's Disease | Experimental: MindTrails Pilot in Huntington's Disease | Total |
|---|---|---|---|
| Female | 9 | 15 | 24 |
| Male | 13 | 6 | 19 |
| Ethnicity (NIH/OMB)(Participants) | Experimental: MindTrails Pilot in Parkinson's Disease | Experimental: MindTrails Pilot in Huntington's Disease | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 3 | 6 |
| Not Hispanic or Latino | 19 | 17 | 36 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Experimental: MindTrails Pilot in Parkinson's Disease | Experimental: MindTrails Pilot in Huntington's Disease | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 21 | 21 | 42 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Experimental: MindTrails Pilot in Parkinson's Disease | Experimental: MindTrails Pilot in Huntington's Disease | Total |
|---|---|---|---|
| United States | 22 | 21 | 43 |
| Education(Participants) | Experimental: MindTrails Pilot in Parkinson's Disease | Experimental: MindTrails Pilot in Huntington's Disease | Total |
|---|---|---|---|
| High School | 2 | 3 | 5 |
| Some College | 3 | 9 | 12 |
| Associate's Degree | 4 | 1 | 5 |
| Bachelor's | 6 | 6 | 12 |
| Master's | 4 | 1 | 5 |
| Doctorate/PhD | 3 | 1 | 4 |
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University of Virginia