Huntington Disease, Parkinson Disease
Conditions
Keywords
Anxiety, Interpretation bias, Cognitive bias modification
Brief 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.
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.
Interventions
BEHAVIORALMindTrails
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.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
University of Virginia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two single groups will be recruited: one including participants with Huntington's disease and the other including participants with Parkinson's disease.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Huntington's disease or Parkinson's disease * Age 21 or older * Has anxiety symptoms (NeuroQoL Anxiety short form \>12)
Exclusion criteria
* Unable to read and understand English * Previously diagnosed with dementia * Not located in the USA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Completing at Least 50% of the MindTrails Sessions | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental: MindTrails Pilot in Parkinson's Disease This intervention involves completion of five, 20-minute MindTrails online training sessions over five weeks. | 22 |
| Experimental: MindTrails Pilot in Huntington's Disease This intervention involves completion of five, 20-minute MindTrails online training sessions over five weeks. | 21 |
| Total | 43 |
Baseline characteristics
| Characteristic | Experimental: MindTrails Pilot in Huntington's Disease | Total | Experimental: MindTrails Pilot in Parkinson's Disease |
|---|---|---|---|
| Age, Continuous | 48.95 years STANDARD_DEVIATION 11.81 | 56.67 years STANDARD_DEVIATION 13.69 | 64.05 years STANDARD_DEVIATION 11.2 |
| Education Associate's Degree | 1 Participants | 5 Participants | 4 Participants |
| Education Bachelor's | 6 Participants | 12 Participants | 6 Participants |
| Education Doctorate/PhD | 1 Participants | 4 Participants | 3 Participants |
| Education High School | 3 Participants | 5 Participants | 2 Participants |
| Education Master's | 1 Participants | 5 Participants | 4 Participants |
| Education Some College | 9 Participants | 12 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 6 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 36 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 42 Participants | 21 Participants |
| Region of Enrollment United States | 21 participants | 43 participants | 22 participants |
| Sex: Female, Male Female | 15 Participants | 24 Participants | 9 Participants |
| Sex: Female, Male Male | 6 Participants | 19 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 21 |
| other Total, other adverse events | 0 / 22 | 0 / 21 |
| serious Total, serious adverse events | 0 / 22 | 0 / 21 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental: MindTrails Pilot in Parkinson's Disease | Participant Perceptions of Perceived Benefits and Limitations of MindTrails | completed it on phone | 3 Participants |
| Experimental: MindTrails Pilot in Parkinson's Disease | Participant Perceptions of Perceived Benefits and Limitations of MindTrails | easy to navigate/ straight-forward | 13 Participants |
| Experimental: MindTrails Pilot in Parkinson's Disease | Participant Perceptions of Perceived Benefits and Limitations of MindTrails | participant baseline characteristics influence experience positively | 4 Participants |
| Experimental: MindTrails Pilot in Parkinson's Disease | Participant Perceptions of Perceived Benefits and Limitations of MindTrails | interesting/ engaging | 5 Participants |
| Experimental: MindTrails Pilot in Parkinson's Disease | Participant Perceptions of Perceived Benefits and Limitations of MindTrails | needed caregiver assistance | 1 Participants |
| Experimental: MindTrails Pilot in Parkinson's Disease | Participant Perceptions of Perceived Benefits and Limitations of MindTrails | neutral experience with MindTrails | 2 Participants |
| Experimental: MindTrails Pilot in Parkinson's Disease | Participant Perceptions of Perceived Benefits and Limitations of MindTrails | participant baseline characteristics influence experience negatively | 4 Participants |
| Experimental: MindTrails Pilot in Parkinson's Disease | Participant Perceptions of Perceived Benefits and Limitations of MindTrails | did not enjoy MindTrails | 0 Participants |
| Experimental: MindTrails Pilot in Parkinson's Disease | Participant Perceptions of Perceived Benefits and Limitations of MindTrails | completed on computer | 3 Participants |
| Experimental: MindTrails Pilot in Parkinson's Disease | Participant Perceptions of Perceived Benefits and Limitations of MindTrails | difficulty with and/or did not like forced response choice | 5 Participants |
| Experimental: MindTrails Pilot in Parkinson's Disease | Participant Perceptions of Perceived Benefits and Limitations of MindTrails | positive experience/ enjoyed MindTrails | 7 Participants |
| Experimental: MindTrails Pilot in Parkinson's Disease | Participant Perceptions of Perceived Benefits and Limitations of MindTrails | redundancy | 4 Participants |
| Experimental: MindTrails Pilot in Parkinson's Disease | Participant Perceptions of Perceived Benefits and Limitations of MindTrails | did not need help to complete | 12 Participants |
| Experimental: MindTrails Pilot in Huntington's Disease | Participant Perceptions of Perceived Benefits and Limitations of MindTrails | redundancy | 2 Participants |
| Experimental: MindTrails Pilot in Huntington's Disease | Participant Perceptions of Perceived Benefits and Limitations of MindTrails | did not need help to complete | 9 Participants |
| Experimental: MindTrails Pilot in Huntington's Disease | Participant Perceptions of Perceived Benefits and Limitations of MindTrails | needed caregiver assistance | 1 Participants |
| Experimental: MindTrails Pilot in Huntington's Disease | Participant Perceptions of Perceived Benefits and Limitations of MindTrails | completed it on phone | 1 Participants |
| Experimental: MindTrails Pilot in Huntington's Disease | Participant Perceptions of Perceived Benefits and Limitations of MindTrails | completed on computer | 3 Participants |
| Experimental: MindTrails Pilot in Huntington's Disease | Participant Perceptions of Perceived Benefits and Limitations of MindTrails | participant baseline characteristics influence experience positively | 4 Participants |
| Experimental: MindTrails Pilot in Huntington's Disease | Participant Perceptions of Perceived Benefits and Limitations of MindTrails | participant baseline characteristics influence experience negatively | 5 Participants |
| Experimental: MindTrails Pilot in Huntington's Disease | Participant Perceptions of Perceived Benefits and Limitations of MindTrails | positive experience/ enjoyed MindTrails | 4 Participants |
| Experimental: MindTrails Pilot in Huntington's Disease | Participant Perceptions of Perceived Benefits and Limitations of MindTrails | easy to navigate/ straight-forward | 10 Participants |
| Experimental: MindTrails Pilot in Huntington's Disease | Participant Perceptions of Perceived Benefits and Limitations of MindTrails | interesting/ engaging | 2 Participants |
| Experimental: MindTrails Pilot in Huntington's Disease | Participant Perceptions of Perceived Benefits and Limitations of MindTrails | neutral experience with MindTrails | 2 Participants |
| Experimental: MindTrails Pilot in Huntington's Disease | Participant Perceptions of Perceived Benefits and Limitations of MindTrails | did not enjoy MindTrails | 1 Participants |
| Experimental: MindTrails Pilot in Huntington's Disease | Participant Perceptions of Perceived Benefits and Limitations of MindTrails | difficulty with and/or did not like forced response choice | 3 Participants |
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)
Time frame: Between baseline and week 5
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental: MindTrails Pilot in Parkinson's Disease | Proportion of Participants Completing at Least 50% of the MindTrails Sessions | 14 Participants |
| Experimental: MindTrails Pilot in Huntington's Disease | Proportion of Participants Completing at Least 50% of the MindTrails Sessions | 14 Participants |