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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR003016 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MindTrails pilot | Experimental | This intervention involves completion of five, 20-minute MindTrails online training sessions over five weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MindTrails | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | After completion of the intervention (week 5) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessie S Gibson, PhD, RN | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: MindTrails Pilot in Parkinson's Disease | This intervention involves completion of five, 20-minute MindTrails online training sessions over five weeks. |
| FG001 | Experimental: MindTrails Pilot in Huntington's Disease | This intervention involves completion of five, 20-minute MindTrails online training sessions over five weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: MindTrails Pilot in Parkinson's Disease | This intervention involves completion of five, 20-minute MindTrails online training sessions over five weeks. |
| BG001 | Experimental: MindTrails Pilot in Huntington's Disease |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Count of Participants | Participants | Between baseline and week 5 |
|
Approximately 13 weeks (5 week intervention period and 2 month follow-up).
Because this study posed minimal risk to the subject, adverse events were only to be collected or recorded if a causal relationship to the study intervention was suspected. No adverse events were reported during the course of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental: MindTrails Pilot in Parkinson's Disease | This intervention involves completion of five, 20-minute MindTrails online training sessions over five weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessie Gibson, PhD, RN | University of Virginia School of Nursing | 434-924-0107 | js6zn@virginia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 26, 2024 | Jul 1, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| D010300 | Parkinson Disease |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Two single groups will be recruited: one including participants with Huntington's disease and the other including participants with Parkinson's disease.
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This intervention involves completion of five, 20-minute MindTrails online training sessions over five weeks.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education | Count of Participants | Participants |
|
|
|
| Primary | 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. | All participants in each arm were invited to complete a semi-structured interview; 14 PD participants and 10 HD participants completed interviews. | Posted | Count of Participants | Participants | After completion of the intervention (week 5) |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Experimental: MindTrails Pilot in Huntington's Disease | This intervention involves completion of five, 20-minute MindTrails online training sessions over five weeks. | 0 | 21 | 0 | 21 | 0 | 21 |
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| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020734 | Parkinsonian Disorders |
| D000080874 | Synucleinopathies |
| completed it on phone |
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| completed on computer |
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| participant baseline characteristics influence experience positively |
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| participant baseline characteristics influence experience negatively |
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| positive experience/ enjoyed MindTrails |
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| easy to navigate/ straight-forward |
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| interesting/ engaging |
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| neutral experience with MindTrails |
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| did not enjoy MindTrails |
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| difficulty with and/or did not like forced response choice |
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| redundancy |
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