HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) -Post-Traumatic Epilepsy (PTE)
NCT ID: NCT05235061
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
160 participants
INTERVENTIONAL
2022-03-21
2026-02-28
Brief Summary
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Detailed Description
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The investigators will test the hypothesis by pursuing the following specific aims:
Aim 1: Adapt the HOBSCOTCH program education module for delivery to patients with PTE and cognitive challenges. The investigators working hypothesis is that the existing education module of the HOBSCOTCH program can be adapted to address key knowledge areas for patients with TBI and PTE and their caregivers.
Aim 2: Evaluate the efficacy of the HOBSCOTCH-PTE program in patients with PTE. The investigators working hypothesis is that the HOBSCOTCH-PTE intervention will improve QOL in PTE patients. The investigators also expect to see improvements in subjective cognition, knowledge, self-efficacy, symptom reduction, and health outcomes.
Aim 3: Incorporate family caregivers into select components of the HOBSCOTCH-PTE intervention and evaluate the effects of the HOBSCOTCH-PTE intervention on the caregiver. The investigators working hypothesis is that family caregivers will have improvement in QOL, caregiver burden, and health status as a result of their family member with PTE participating in the HOBSCOTCH-PTE intervention, and by their own participation in the HOBSCOTCH-PTE modules delivering disease specific education and mindfulness skill building exercises.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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PTE Participant Group 1
PTE Participant Group 1 will receive the HOBSCOTCH-PTE intervention consisting of 1:1 sessions delivered once per week including:
* 1 pre-HOBSCOTCH Session (on webcam)
* 1 educational session (on webcam)
* 6 telephone sessions
* 1 wrap-up session (webcam or telephone)
Home Based Self-management and Cognitive Training Changes lives in post traumatic epilepsy (HOBSCOTCH-PTE)
HOBSCOTCH is a home-based self-management program to treat cognitive symptoms and improve quality of life, while minimizing the barriers of access to care. The program is based on Problem Solving Therapy (PST) and teaches problem solving strategies and compensatory mechanisms to help manage cognitive dysfunction and enhance quality of life. HOBSCOTCH-PTE is an adaptation of the HOBSCOTCH program for people with a traumatic brain injury and post-traumatic epilepsy that incorporates education about TBI, PTE, and cognition into the education module.
PTE Participant Group 2
PTE Participant Group 2 will be on a 3-month wait list after which they will receive HOBSCOTCH-PTE consisting of 1:1 sessions delivered once per week including:
* 1 pre-HOBSCOTCH Session (on webcam)
* 1 educational session (on webcam)
* 6 telephone sessions
* 1 wrap-up session (webcam or telephone)
Home Based Self-management and Cognitive Training Changes lives in post traumatic epilepsy (HOBSCOTCH-PTE)
HOBSCOTCH is a home-based self-management program to treat cognitive symptoms and improve quality of life, while minimizing the barriers of access to care. The program is based on Problem Solving Therapy (PST) and teaches problem solving strategies and compensatory mechanisms to help manage cognitive dysfunction and enhance quality of life. HOBSCOTCH-PTE is an adaptation of the HOBSCOTCH program for people with a traumatic brain injury and post-traumatic epilepsy that incorporates education about TBI, PTE, and cognition into the education module.
PTE Caregiver Group 1
Caregiver Group 1 will receive an adapted version of HOBSCOTCH-PTE by attending session 1 of the HOBSCOTCH-PTE (virtual) program with their PTE patient as well as guidance and instructions on utilizing quick relaxation. Caregiver Group 1 will also attend session 8 of the program with the PTE patient to focus on program wrap-up and maintenance planning.
HOBSCOTCH-PTE for Caregivers
Select components of the HOBSCOTCH-PTE program delivered to caregivers consist of session 1 of the HOBSCOTCH-PTE (virtual) program (education module), guidance and instructions on utilizing quick relaxation, and session 8 of the HOBSCOTCH-PTE program (program wrap-up and maintenance planning).
PTE Caregiver Group 2
Caregiver Group 2 will be on a 3 month wait list with their PTE patient after which time they will receive an adapted version of HOBSCOTCH-PTE by attending session 1 of the HOBSCOTCH-PTE (virtual) program with their PTE patient as well as guidance and instructions on utilizing quick relaxation. Caregiver Group 2 will also attend session 8 of the program with the PTE patient to focus on program wrap-up and maintenance planning.
HOBSCOTCH-PTE for Caregivers
Select components of the HOBSCOTCH-PTE program delivered to caregivers consist of session 1 of the HOBSCOTCH-PTE (virtual) program (education module), guidance and instructions on utilizing quick relaxation, and session 8 of the HOBSCOTCH-PTE program (program wrap-up and maintenance planning).
Interventions
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Home Based Self-management and Cognitive Training Changes lives in post traumatic epilepsy (HOBSCOTCH-PTE)
HOBSCOTCH is a home-based self-management program to treat cognitive symptoms and improve quality of life, while minimizing the barriers of access to care. The program is based on Problem Solving Therapy (PST) and teaches problem solving strategies and compensatory mechanisms to help manage cognitive dysfunction and enhance quality of life. HOBSCOTCH-PTE is an adaptation of the HOBSCOTCH program for people with a traumatic brain injury and post-traumatic epilepsy that incorporates education about TBI, PTE, and cognition into the education module.
HOBSCOTCH-PTE for Caregivers
Select components of the HOBSCOTCH-PTE program delivered to caregivers consist of session 1 of the HOBSCOTCH-PTE (virtual) program (education module), guidance and instructions on utilizing quick relaxation, and session 8 of the HOBSCOTCH-PTE program (program wrap-up and maintenance planning).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of post traumatic epilepsy, with controlled or uncontrolled seizures
* Subjective memory complaints
* No changes in antiepileptic and antidepressant medication regimen for 1 month, however brief discontinuation of antiepileptic medicine for inpatient video EEG evaluation is acceptable
* Literate and proficient in English
* Telephone access
* Internet access
* Age 18+
* Caregivers to a patient with a confirmed diagnosis of PTE
* Literate and proficient in English
* Telephone access
* Internet access
Exclusion Criteria
* Severe mental disability or estimated IQ less than 70 per clinical judgement
* Significant visual impairment precluding reading or writing
* No reliable telephone or internet access
* No diagnosis of epilepsy
* Significant visual impairment precluding reading or writing
* No reliable telephone or internet access
18 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Dartmouth-Hitchcock Medical Center
OTHER
Responsible Party
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Barbara Jobst
Chair, Department of Neurology; Professor of Neurology
Principal Investigators
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Barbara C. Jobst, MD, Dr. Med.
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Elaine T Kiriakopoulos, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Locations
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Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Countries
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References
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Caller TA, Ferguson RJ, Roth RM, Secore KL, Alexandre FP, Zhao W, Tosteson TD, Henegan PL, Birney K, Jobst BC. A cognitive behavioral intervention (HOBSCOTCH) improves quality of life and attention in epilepsy. Epilepsy Behav. 2016 Apr;57(Pt A):111-117. doi: 10.1016/j.yebeh.2016.01.024. Epub 2016 Mar 2.
Other Identifiers
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W81XW82110279
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY02001238
Identifier Type: -
Identifier Source: org_study_id