Huntington DiseaseNCT05126862
Measurement and Modification of Threat Interpretation Bias in Neurodegenerative Movement Disorders (Aims 2 & 3)
A study testing MindTrails in people with Huntington Disease and Parkinson Disease, run by University of Virginia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Huntington Disease, Parkinson Disease
- What is being tested?
- MindTrails
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2021to 9 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Huntington's disease or Parkinson's disease
- Age 21 or older
- Has anxiety symptoms (NeuroQoL Anxiety short form >12)
Who cannot join
- Unable to read and understand English
- Previously diagnosed with dementia
- Not located in the USA
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
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.
Read the detailed description
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.
- Conditions
- Huntington Disease, Parkinson Disease
- Being tested
- MindTrails
- Keywords
- Anxiety, Interpretation bias, Cognitive bias modification
- Medical subject headings
- Huntington Disease, Parkinson Disease, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindTrailsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MindTrails pilot | Experimental | This intervention involves completion of five, 20-minute MindTrails online training sessions over five weeks. Receives: Behavioral: MindTrails |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: After completion of the intervention (week 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start10 Dec 2021
- Primary completion9 Jul 2023
- Study completion9 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Two single groups will be recruited: one including participants with Huntington's disease and the other including participants with Parkinson's disease.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Jessie Gibson, PhD, RN, University of Virginia
- Investigators
- Jessie S Gibson, PhD, RN, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126862
- Sponsor's protocol ID
- HSR 210113
- Other IDs
- KL2TR003016
- Status last verified
- Dec 2024
- First submitted
- 9 Nov 2021
- Last updated
- 20 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement and Modification of Threat Interpretation Bias in Neurodegenerative Movement Disorders (Aims 2 & 3)
- ClinicalTrials.gov ID
- NCT05126862
- Acronym / sponsor ID
- HSR 210113
- Conditions
- Huntington Disease, Parkinson Disease
- Keywords
- Anxiety, Interpretation bias, Cognitive bias modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 9 Jul 2023 (actual)
- Study completion
- 9 Jul 2023 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Posted 20 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Two single groups will be recruited: one including participants with Huntington's disease and the other including participants with Parkinson's disease.
| Arm | Type | Receives |
|---|---|---|
| MindTrails pilot | Experimental | Behavioral: MindTrailsThis intervention involves completion of five, 20-minute MindTrails online training sessions over five weeks. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Huntington's disease or Parkinson's disease
- Age 21 or older
- Has anxiety symptoms (NeuroQoL Anxiety short form >12)
Key exclusion criteria (3 listed)
- Unable to read and understand English
- Previously diagnosed with dementia
- Not located in the USA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindTrailsMindTrails 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. | Behavioural | MindTrails pilot |
Primary outcome
Proportion of Participants Completing at Least 50% of the MindTrails Sessions
Time frame: Between baseline and week 5
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)
Participant Perceptions of Perceived Benefits and Limitations of MindTrails
Time frame: After completion of the intervention (week 5)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessie S Gibson, PhD, RN principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MindTrails in people with Huntington Disease and Parkinson Disease, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Completing at Least 50% of the MindTrails Sessions (time frame: Between baseline and week 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.