Epilepsy, TraumaticHOBSCOTCHPTENCT05235061

HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) -Post-Traumatic Epilepsy (PTE)

A study testing Home Based Self-management and Cognitive Training Changes lives in post traumatic epilepsy (HOBSCOTCH-PTE) and HOBSCOTCH-PTE for Caregivers in people with Epilepsy, Traumatic and Brain Injuries, Traumatic, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Epilepsy, Traumatic, Brain Injuries, Traumatic
What is being tested?: Home Based Self-management and Cognitive Training Changes lives in post traumatic epilepsy (HOBSCOTCH-PTE) and HOBSCOTCH-PTE for Caregivers
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 1 siteUnited States
Study dates: 21 Mar 2022to Dec 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18+
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

Show all 12Show fewer

Internet access
Age 18+
Caregivers to a patient with a confirmed diagnosis of PTE
Literate and proficient in English
Telephone access
Internet access

Who cannot join

Subjects self-reporting a dementing illness or a mention of a dementing illness in their medical record
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

Trial locations and contacts

1 site in 1 country.

United States1 site

Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756

Other trials in United States

About this study

The purpose of this study is to assess the ability of the home-based intervention, HOBSCOTCH-PTE, to improve the quality of life and cognitive function in Service Members, Veterans and civilians with post traumatic epilepsy (PTE). This study will also assess the ability of the HOBSCOTCH-PTE program to improve quality of life in caregivers of PTE patients and to reduce caregiver burden.

Read the detailed description

The investigators hypothesis is that the home-based intervention (HOBSCOTCH-PTE) will improve quality of life and cognitive function in Service Members, Veterans and civilians with PTE. The integration of family caregiver participation in the HOBSCOTCH-PTE intervention will reduce caregiver burden and increase caregiver knowledge of their loved one's disease and cognitive challenges they face, ultimately leading to an improvement in caregiver quality of life.

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: Epilepsy, Traumatic, Brain Injuries, Traumatic
Being tested: Home Based Self-management and Cognitive Training Changes lives in post traumatic epilepsy (HOBSCOTCH-PTE), HOBSCOTCH-PTE for Caregivers
Keywords: Epilepsy, Epilepsy, Post-Traumatic, Traumatic Brain Injury, Cognition, Self-Management, Cognitive remediation, Seizures, Memory Disorders, Caregivers, Caregiver Burden, Mindfulness
Medical subject headings: Epilepsy, Post-Traumatic, Brain Injuries, Traumatic, Epilepsy, Seizures, Memory Disorders, Caregiver Burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Home Based Self-management and Cognitive Training Changes lives in post traumatic epilepsy (HOBSCOTCH-PTE)Behavioural
Also called 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 CaregiversBehavioural
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).

Study groups in NCT05235061
Study group	Role	What they receive
PTE Participant Group 1	Experimental	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) Receives: Behavioral: Home Based Self-management and Cognitive Training Changes lives in post traumatic epilepsy (HOBSCOTCH-PTE)
PTE Participant Group 2	Other	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) Receives: Behavioral: Home Based Self-management and Cognitive Training Changes lives in post traumatic epilepsy (HOBSCOTCH-PTE)
PTE Caregiver Group 1	Experimental	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. Receives: Behavioral: HOBSCOTCH-PTE for Caregivers
PTE Caregiver Group 2	Other	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. Receives: Behavioral: HOBSCOTCH-PTE for Caregivers

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in quality of life as measured by comparing QOLIE-31 scores at baseline and 3 months post-intervention in participants with PTE
The Quality of Life in Epilepsy (QOLIE-31) is a validated tool containing 16 multi-item scales which assess health related quality of life, emotional well-being, memory and attention deficits, medication effects, seizure control, psychosocial functioning, and health perception. Scores range from 0 to 100, with a higher score reflecting a higher quality of life.
Measured: Baseline and 3 months post-intervention.
Change in subjective cognition as measured by comparing NeuroQOL - Cognitive Function sub-scale scores at baseline and 3 months post-intervention in participants with PTE
The Cognitive Function sub-scale of the NeuroQOL is a brief validated tool developed by the NIH for use in patients with neurological disease. Scores range from 8 to 40, with a higher score indicating better reported cognitive functioning.
Measured: Baseline, 3 months, 6 months
Change in caregiver burden as measured by comparing Zarit Burden Interview scores at baseline and at 3 months post-intervention in caregivers of PTE participants
The Zarit Burden Interview is a 22-item questionnaire designed to measure the extent to which a caregiver perceives his or her level of burden as a result of caring for a person with a particular diagnosis. A 5 point Likert scale is used with a higher score indicating a greater level of perceived burden.
Measured: Baseline and 3 months post-intervention

Secondary outcomes (17)

Changes in PTE participant knowledge of their own epilepsy as measured by comparing scores on the Epilepsy Knowledge of Own Condition questionnaire at baseline and 6 months post-intervention.
The Epilepsy Knowledge of Own Condition is a 23 item, mostly YES/NO, questionnaire developed and validated by S. Jarvie, C. Espie, M. Brodie Published 1 September 1993questionnaire to assess knowledge of epilepsy: 2-knowledge of own condition.
Measured: Baseline and 6 months post-intervention.
Changes in PTE participants self-efficacy (subjective impression of managing their life with epilepsy) as measured by comparing scores on the Epilepsy Self-Efficacy Scale at baseline and at 3 months post-intervention.
The Epilepsy Self-Efficacy Scale is validated a 33-item scale that measures the different aspects of efficacy in the self-management of epilepsy. Items are rated on an 11-point Likert rating scale, ranging from 0, I cannot do at all, to 10, sure I can do.
Measured: Baseline and 3 months post-intervention.
Changes in PTE participants' objective cognition as measured by comparing scores on the Montreal Cognitive Assessment (MoCA) at baseline and at 3 months post-intervention.
The Montreal Cognitive Assessment (MoCA) is a validated 30 item test that helps healthcare professionals detect cognitive impairments.
Measured: Baseline and 3 months post-intervention.
Changes in PTE Participants' mood as measured by comparing scores on the Patient Health Questionnaire (PHQ-9) at baseline and at 3 months post- intervention.
The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day).
Measured: Baseline and at 3 months post-intervention
Changes in seizure frequency (PTE participants) as measured by comparing daily self-reported seizures at baseline and at 3 months post-intervention
PTE participants will self-report their seizure activity using a smartphone app or paper log. The smart phone app was developed by the HOBSCOTH program at Dartmouth-Hitchcock and is used clinically in the HOBSCOTCH program.
Measured: Recorded daily and compared between baseline and 3 months-post intervention.
Changes in PTE participants' medication adherence as measured by a daily self-reported diary compared at baseline and at 3 months post-intervention.
PTE participants will self-report their medication adherence activity using a smartphone app or paper log. The smart phone app was developed by the HOBSCOTH program at Dartmouth-Hitchcock and is used clinically in the HOBSCOTCH program.
Measured: Recorded daily and compared between baseline and 3 months post-intervention.
Changes in PTE participants' use of memory strategies as measured by a daily self-reported diary compared at baseline and 3 months post-intervention.
PTE participants will self-report their use of the memory strategies they learn in the HOBSCOTCH-PTE program using a smartphone app developed by the HOBSCOTH program at Dartmouth-Hitchcock or in a paper log.
Measured: Recorded daily and compared between baseline and 3 months post-intervention.
Changes in PTE participants' self-reports of wellbeing as measured by comparing daily reports of well-being in a diary at baseline and at 3 months post-intervention.
The researchers will collect daily well-being information throughout the entire study by use of a smartphone app or paper log and a basic single item Likert-scale of well-being.
Measured: Recorded daily and compared between baseline and 3 months post-intervention.
Changes in Caregiver Participants' knowledge of epilepsy as measured by comparing scores on the [Caregiver] General Knowledge of Epilepsy questionnaire at baseline and at 6 months-post intervention.
The [Caregivers] General Knowledge of Epilepsy is a validated 34 item TRUE/FALSE questionnaire developed to assess general knowledge of epilepsy. (Jarvie S, Espie CA, Brodie MJ. The development of a questionnaire to assess the knowledge of epilepsy, 1: general knowledge of epilepsy. Seizure 1993; 2: 179- 85.)
Measured: Baseline and 6 months post-intervention.
Changes in caregiver self-reported health status as measured by comparing scores on the Short-Form 36 (SF-36) at baseline and 3 months-post intervention.
The Short Form Health Survey (SF-36) is a validated 36-item, patient-reported survey of patient health. It consists of 8 sub-scales, which are scored on a 3-point, 5-point or dichotomous (yes/no or true/false) scale. The scores are converted to a 1 - 100 point scale with a lower score indicating more disability, i.e. 0 = maximum disability and 100 = no disability.
Measured: Baseline and 3 months post-intervention.
Changes in Caregiver Participants' mood as measured by comparing scores on the Patient Health Questionnaire (PHQ-9) at baseline and at 3 months post- intervention.
The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day).
Measured: Baseline and at 3 months post-intervention
Sustainability of improvement on primary outcome measure for PTE Participants by comparing scores on the QOLIE-31 at 3 months and 6 months post-intervention.
The Quality of Life in Epilepsy (QOLIE-31) is a validated tool containing 16 multi-item scales which assess health related quality of life, emotional well-being, memory and attention deficits, medication effects, seizure control, psychosocial functioning, and health perception. Scores range from 0 to 100, with a higher score reflecting a higher quality of life.
Measured: 3 months 6 months post intervention.
Sustainability of improvement on primary outcome measures for PTE Participants by comparing scores on the Cognitive Function sub-scale of the NeuroQOL at 3 months and 6 months post-intervention.
The Cognitive Function sub-scale of the NeuroQOL is a brief validated tool developed by the NIH for use in patients with neurological disease. Scores range from 8 to 40, with a higher score indicating better reported cognitive functioning.
Measured: 3 months 6 months post intervention.
Sustainability of improvement on primary outcome measures for Caregiver Participants by comparing scores on the Zarit Caregiver Burden at 3 months and 6 months post-intervention.
The Zarit Burden Interview is a 22-item questionnaire designed to measure the extent to which a caregiver perceives his or her level of burden as a result of caring for a person with a particular diagnosis. A 5 point Likert scale is used with a higher score indicating a greater level of perceived burden.
Measured: 3 months 6 months post intervention.
Engagement and Satisfaction for PTE Participants as measured by analyzing study attrition and a Participant Satisfaction Survey at the end of the study.
The Participant Satisfaction Survey has been developed through the original HOBSCOTH program and is used in clinical practice for quality improvement. It contains 10 items scored on a 5-point Likert scale with a higher score indicating greater satisfaction with the program.
Measured: 6 months post-intervention (end of study)
HOBSCOTCH Fidelity and Compliance as measured by completed sessions and completed homework for PTE Participants.
Completed sessions and homework are tracked throughout the study by the certified HOBSCOTCH coaches.
Measured: 6 months post-intervention (end of study)
Feasibility of HOBSCOTCH program for Caregivers as measured by study attrition and a Participant Satisfaction Survey.
The Participant Satisfaction Survey was developed through the original HOBSCOTH program and is used in clinical practice for quality improvement. It has been modified to address Caregiver's satisfaction as a result or participating in this study and contains 9 items scored on a 5-point Likert scale with a higher score indicating greater satisfaction with the program.
Measured: 6 months post-intervention (end of study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Mar 2022Dec 2026

First posted10 Feb 2022
Study start21 Mar 2022
Primary completion31 Oct 2025
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Epilepsy, TraumaticStudies of the same condition, open and under way.
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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05235061
Sponsor's protocol ID: STUDY02001238
Other IDs: W81XW82110279
Acronym: HOBSCOTCHPTE
Status last verified: Mar 2026
First submitted: 11 Jan 2022
Last updated: 19 Mar 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The Dartmouth-Hitchcock study team will share data with the MEW Network Database team at Case Western Reserve University. HOBSCOTCH is a part of the Managing Epilepsy Well Network (MEWN), MEWN has been a national leader in developing, testing and disseminating evidence-based epilepsy self-management programs. Collectively, the MEWN has an integrated database using MEW common data elements (e.g., demographics, seizure details, quality of life, depression) (1). Sajatovic, M., B. Wilson, R. Shegog, B.S.B. F, C. Escoffery, B.C. Jobst, E.K. Johnson, R.T. Fraser, R.C. Quarells, and T.M. Spruill, The Managing Epilepsy Well (MEW) network database: Lessons learned in refining and implementing an integrated data tool in service of a national U.S. Research Collaborative. Epilepsy Behav, 2021. 115: p. 107650.

Publications

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.
PubMed 26943948

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Epilepsy, Traumatic trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) -Post-Traumatic Epilepsy (PTE)
ClinicalTrials.gov ID: NCT05235061
Acronym / sponsor ID: HOBSCOTCHPTE / STUDY02001238
Conditions: Epilepsy, Traumatic, Brain Injuries, Traumatic
Keywords: Epilepsy, Epilepsy, Post-Traumatic, Traumatic Brain Injury, Cognition, Self-Management, Cognitive remediation, Seizures, Memory Disorders
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 160 participants (actual)
Lead sponsor: Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
Collaborators: United States Department of Defense
Study start: 21 Mar 2022 (actual)
Primary completion: 31 Oct 2025 (actual)
Study completion: Dec 2026 (estimated)
First posted: 10 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The investigators will test the hypothesis by pursuing the following specific aims:

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
PTE Participant Group 1	Experimental	Behavioral: Home Based Self-management and Cognitive Training Changes lives in post traumatic epilepsy (HOBSCOTCH-PTE)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)
PTE Participant Group 2	Other	Behavioral: Home Based Self-management and Cognitive Training Changes lives in post traumatic epilepsy (HOBSCOTCH-PTE)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)
PTE Caregiver Group 1	Experimental	Behavioral: HOBSCOTCH-PTE for CaregiversCaregiver 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.
PTE Caregiver Group 2	Other	Behavioral: HOBSCOTCH-PTE for CaregiversCaregiver 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Age 18+
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

Key exclusion criteria (7 listed)

Subjects self-reporting a dementing illness or a mention of a dementing illness in their medical record
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

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
Home Based Self-management and Cognitive Training Changes lives in post traumatic epilepsy (HOBSCOTCH-PTE)Also: HOBSCOTCH-PTEHOBSCOTCH 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.	Behavioural	PTE Participant Group 1, PTE Participant Group 2
HOBSCOTCH-PTE for CaregiversSelect 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).	Behavioural	PTE Caregiver Group 1, PTE Caregiver Group 2

Primary outcome

Change in quality of life as measured by comparing QOLIE-31 scores at baseline and 3 months post-intervention in participants with PTE
Time frame: Baseline and 3 months post-intervention.
The Quality of Life in Epilepsy (QOLIE-31) is a validated tool containing 16 multi-item scales which assess health related quality of life, emotional well-being, memory and attention deficits, medication effects, seizure control, psychosocial functioning, and health perception. Scores range from 0 to 100, with a higher score reflecting a higher quality of life.
Change in subjective cognition as measured by comparing NeuroQOL - Cognitive Function sub-scale scores at baseline and 3 months post-intervention in participants with PTE
Time frame: Baseline, 3 months, 6 months
The Cognitive Function sub-scale of the NeuroQOL is a brief validated tool developed by the NIH for use in patients with neurological disease. Scores range from 8 to 40, with a higher score indicating better reported cognitive functioning.
Change in caregiver burden as measured by comparing Zarit Burden Interview scores at baseline and at 3 months post-intervention in caregivers of PTE participants
Time frame: Baseline and 3 months post-intervention
The Zarit Burden Interview is a 22-item questionnaire designed to measure the extent to which a caregiver perceives his or her level of burden as a result of caring for a person with a particular diagnosis. A 5 point Likert scale is used with a higher score indicating a greater level of perceived burden.

17 secondary outcomes

Changes in PTE participant knowledge of their own epilepsy as measured by comparing scores on the Epilepsy Knowledge of Own Condition questionnaire at baseline and 6 months post-intervention.
Time frame: Baseline and 6 months post-intervention.
Changes in PTE participants self-efficacy (subjective impression of managing their life with epilepsy) as measured by comparing scores on the Epilepsy Self-Efficacy Scale at baseline and at 3 months post-intervention.
Time frame: Baseline and 3 months post-intervention.
Changes in PTE participants' objective cognition as measured by comparing scores on the Montreal Cognitive Assessment (MoCA) at baseline and at 3 months post-intervention.
Time frame: Baseline and 3 months post-intervention.
Changes in PTE Participants' mood as measured by comparing scores on the Patient Health Questionnaire (PHQ-9) at baseline and at 3 months post- intervention.
Time frame: Baseline and at 3 months post-intervention
Changes in seizure frequency (PTE participants) as measured by comparing daily self-reported seizures at baseline and at 3 months post-intervention
Time frame: Recorded daily and compared between baseline and 3 months-post intervention.
Changes in PTE participants' medication adherence as measured by a daily self-reported diary compared at baseline and at 3 months post-intervention.
Time frame: Recorded daily and compared between baseline and 3 months post-intervention.
Changes in PTE participants' use of memory strategies as measured by a daily self-reported diary compared at baseline and 3 months post-intervention.
Time frame: Recorded daily and compared between baseline and 3 months post-intervention.
Changes in PTE participants' self-reports of wellbeing as measured by comparing daily reports of well-being in a diary at baseline and at 3 months post-intervention.
Time frame: Recorded daily and compared between baseline and 3 months post-intervention.
Changes in Caregiver Participants' knowledge of epilepsy as measured by comparing scores on the [Caregiver] General Knowledge of Epilepsy questionnaire at baseline and at 6 months-post intervention.
Time frame: Baseline and 6 months post-intervention.
Changes in caregiver self-reported health status as measured by comparing scores on the Short-Form 36 (SF-36) at baseline and 3 months-post intervention.
Time frame: Baseline and 3 months post-intervention.
Changes in Caregiver Participants' mood as measured by comparing scores on the Patient Health Questionnaire (PHQ-9) at baseline and at 3 months post- intervention.
Time frame: Baseline and at 3 months post-intervention
Sustainability of improvement on primary outcome measure for PTE Participants by comparing scores on the QOLIE-31 at 3 months and 6 months post-intervention.
Time frame: 3 months 6 months post intervention.
Sustainability of improvement on primary outcome measures for PTE Participants by comparing scores on the Cognitive Function sub-scale of the NeuroQOL at 3 months and 6 months post-intervention.
Time frame: 3 months 6 months post intervention.
Sustainability of improvement on primary outcome measures for Caregiver Participants by comparing scores on the Zarit Caregiver Burden at 3 months and 6 months post-intervention.
Time frame: 3 months 6 months post intervention.
Engagement and Satisfaction for PTE Participants as measured by analyzing study attrition and a Participant Satisfaction Survey at the end of the study.
Time frame: 6 months post-intervention (end of study)
HOBSCOTCH Fidelity and Compliance as measured by completed sessions and completed homework for PTE Participants.
Time frame: 6 months post-intervention (end of study)
Feasibility of HOBSCOTCH program for Caregivers as measured by study attrition and a Participant Satisfaction Survey.
Time frame: 6 months post-intervention (end of study)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
Background: PubMed 26943948Caller 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.
Individual participant dataSharing planned: Yes. The Dartmouth-Hitchcock study team will share data with the MEW Network Database team at Case Western Reserve University. HOBSCOTCH is a part of the Managing Epilepsy Well Network (MEWN), MEWN has been a national leader in developing, testing and disseminating evidence-based epilepsy self-management programs. Collectively, the MEWN has an integrated database using MEW common data elements (e.g., demographics, seizure details, quality of life, depression) (1). Sajatovic, M., B. Wilson, R. Shegog, B.S.B. F, C. Escoffery, B.C. Jobst, E.K. Johnson, R.T. Fraser, R.C. Quarells, and T.M. Spruill, The Managing Epilepsy Well (MEW) network database: Lessons learned in refining and implementing an integrated data tool in service of a national U.S. Research Collaborative. Epilepsy Behav, 2021. 115: p. 107650.

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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.

Barbara C. Jobst, MD, Dr. Med. principal investigator

Dartmouth-Hitchcock Medical Center

Elaine T Kiriakopoulos, MD, MSc principal investigator

Dartmouth-Hitchcock Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

Change in quality of life as measured by comparing QOLIE-31 scores at baseline and 3 months post-intervention in participants with PTE (time frame: Baseline and 3 months post-intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05235061, which also lists 1 linked publication.

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 19 Mar 2026.