Trial Outcomes & Findings for Motivational Interviewing to Enhance Adherence of Patients With Psychogenic Non-epileptic Seizures (NCT NCT02598076)
NCT ID: NCT02598076
Last Updated: 2019-04-24
Results Overview
Patients are classified as adherent if they attend 8 or more of the recommended 12 weekly psychotherapy sessions over a 16 week period. Otherwise they are classified as non-adherent.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
4 months
Results posted on
2019-04-24
Participant Flow
Participant milestones
| Measure |
Control
Group will receive standard treatment for psychogenic non-epileptic seizures. They will undergo an initial clinic visit with a neuropsychiatrist and neurologists. They will not undergo any subsequent motivational interview. Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at Brigham and Women's Hospital or referred to a local psychotherapist according to their preference.
standard psychotherapy: Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES
|
Motivational Interviewing
Group will receive an initial clinic visit with a neuropsychiatrist and neurologists, identical to the initial clinic visit for the control group. In addition they will receive 1 session of motivational interviewing immediately following the initial clinic visit. These patients will be questioned using standardized motivational interviewing techniques by a board certified neurologist with formal training and certification in motivational interviewing.
Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at BWH or referred to a local psychotherapist according to their preference.
motivational interviewing: Motivational interviews will include the classical 4 steps of MI: 1) engagement; 2) focusing; 3) strengthening motivation; and 4) planning.
standard psychotherapy: Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
29
|
|
Overall Study
COMPLETED
|
29
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Control
Group will receive standard treatment for psychogenic non-epileptic seizures. They will undergo an initial clinic visit with a neuropsychiatrist and neurologists. They will not undergo any subsequent motivational interview. Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at Brigham and Women's Hospital or referred to a local psychotherapist according to their preference.
standard psychotherapy: Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES
|
Motivational Interviewing
Group will receive an initial clinic visit with a neuropsychiatrist and neurologists, identical to the initial clinic visit for the control group. In addition they will receive 1 session of motivational interviewing immediately following the initial clinic visit. These patients will be questioned using standardized motivational interviewing techniques by a board certified neurologist with formal training and certification in motivational interviewing.
Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at BWH or referred to a local psychotherapist according to their preference.
motivational interviewing: Motivational interviews will include the classical 4 steps of MI: 1) engagement; 2) focusing; 3) strengthening motivation; and 4) planning.
standard psychotherapy: Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
Baseline Characteristics
participant unwilling to complete baseline questionnaire
Baseline characteristics by cohort
| Measure |
Control
n=31 Participants
Group will receive standard treatment for psychogenic non-epileptic seizures. They will undergo an initial clinic visit with a neuropsychiatrist and neurologists. They will not undergo any subsequent motivational interview. Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at Brigham and Women's Hospital or referred to a local psychotherapist according to their preference.
standard psychotherapy: Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES
|
Motivational Interviewing
n=29 Participants
Group will receive an initial clinic visit with a neuropsychiatrist and neurologists, identical to the initial clinic visit for the control group. In addition they will receive 1 session of motivational interviewing immediately following the initial clinic visit. These patients will be questioned using standardized motivational interviewing techniques by a board certified neurologist with formal training and certification in motivational interviewing.
Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at BWH or referred to a local psychotherapist according to their preference.
motivational interviewing: Motivational interviews will include the classical 4 steps of MI: 1) engagement; 2) focusing; 3) strengthening motivation; and 4) planning.
standard psychotherapy: Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.7 years
STANDARD_DEVIATION 14.3 • n=31 Participants
|
39.6 years
STANDARD_DEVIATION 16.8 • n=29 Participants
|
40.2 years
STANDARD_DEVIATION 15.4 • n=60 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=31 Participants
|
23 Participants
n=29 Participants
|
49 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=31 Participants
|
6 Participants
n=29 Participants
|
11 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
African-American
|
3 Participants
n=31 Participants
|
3 Participants
n=29 Participants
|
6 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
7 Participants
n=31 Participants
|
6 Participants
n=29 Participants
|
13 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
20 Participants
n=31 Participants
|
20 Participants
n=29 Participants
|
40 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=31 Participants
|
0 Participants
n=29 Participants
|
1 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=31 Participants
|
29 participants
n=29 Participants
|
60 participants
n=60 Participants
|
|
years of education
|
13.8 years
STANDARD_DEVIATION 2.5 • n=31 Participants • participant unwilling to complete baseline questionnaire
|
13.0 years
STANDARD_DEVIATION 2.7 • n=28 Participants • participant unwilling to complete baseline questionnaire
|
13.4 years
STANDARD_DEVIATION 2.6 • n=59 Participants • participant unwilling to complete baseline questionnaire
|
|
household income
|
42000 dollars
n=19 Participants • participants unwilling to provide information
|
30000 dollars
n=21 Participants • participants unwilling to provide information
|
33000 dollars
n=40 Participants • participants unwilling to provide information
|
|
major depressive disorder
|
13 Participants
n=31 Participants • participant unwilling to provide information
|
12 Participants
n=28 Participants • participant unwilling to provide information
|
25 Participants
n=59 Participants • participant unwilling to provide information
|
|
generalized anxiety disorder
|
19 Participants
n=31 Participants • participant unwilling to complete baseline questionnaire
|
15 Participants
n=28 Participants • participant unwilling to complete baseline questionnaire
|
34 Participants
n=59 Participants • participant unwilling to complete baseline questionnaire
|
|
Post traumatic stress disorder
|
10 Participants
n=31 Participants • participant unwilling to provide information
|
12 Participants
n=28 Participants • participant unwilling to provide information
|
22 Participants
n=59 Participants • participant unwilling to provide information
|
|
History of abuse
physical abuse
|
11 Participants
n=31 Participants • participant unwilling to provide information
|
11 Participants
n=28 Participants • participant unwilling to provide information
|
22 Participants
n=59 Participants • participant unwilling to provide information
|
|
History of abuse
sexual abuse
|
15 Participants
n=31 Participants • participant unwilling to provide information
|
13 Participants
n=28 Participants • participant unwilling to provide information
|
28 Participants
n=59 Participants • participant unwilling to provide information
|
|
History of abuse
emotional abuse
|
11 Participants
n=31 Participants • participant unwilling to provide information
|
11 Participants
n=28 Participants • participant unwilling to provide information
|
22 Participants
n=59 Participants • participant unwilling to provide information
|
|
History of abuse
any abuse
|
18 Participants
n=31 Participants • participant unwilling to provide information
|
18 Participants
n=28 Participants • participant unwilling to provide information
|
36 Participants
n=59 Participants • participant unwilling to provide information
|
|
delay to diagnosis of PNES
|
3 months
n=31 Participants • participant unwilling to provide information
|
9 months
n=28 Participants • participant unwilling to provide information
|
7 months
n=59 Participants • participant unwilling to provide information
|
|
psychogenic seizure frequency
|
3 PNES per week
n=31 Participants • participant unwilling to provide information
|
4 PNES per week
n=28 Participants • participant unwilling to provide information
|
4 PNES per week
n=59 Participants • participant unwilling to provide information
|
|
Quality of Life in Epilepsy (QOLIE)-10
|
28.0 units on a scale
STANDARD_DEVIATION 9.5 • n=25 Participants • participants unwilling to complete instrument
|
28.4 units on a scale
STANDARD_DEVIATION 8.8 • n=25 Participants • participants unwilling to complete instrument
|
28.2 units on a scale
STANDARD_DEVIATION 9.0 • n=50 Participants • participants unwilling to complete instrument
|
|
Emergency Department visits per month
|
1 visits per month
n=28 Participants • participants unwilling to provide information
|
1 visits per month
n=26 Participants • participants unwilling to provide information
|
1 visits per month
n=54 Participants • participants unwilling to provide information
|
|
referred to psychotherapy at Brigham and Women's Hospital
|
17 Participants
n=31 Participants
|
13 Participants
n=29 Participants
|
30 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: Analysis population includes all participants for whom follow-up data was available. Patients who were lost to contact (after 7 phone calls and a mailed letter) for whom follow-up data was not available, were excluded from analysis.
Patients are classified as adherent if they attend 8 or more of the recommended 12 weekly psychotherapy sessions over a 16 week period. Otherwise they are classified as non-adherent.
Outcome measures
| Measure |
Control
n=29 Participants
Group will receive standard treatment for psychogenic non-epileptic seizures. They will undergo an initial clinic visit with a neuropsychiatrist and neurologists. They will not undergo any subsequent motivational interview. Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at Brigham and Women's Hospital or referred to a local psychotherapist according to their preference.
standard psychotherapy: Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES
|
Motivational Interviewing
n=26 Participants
Group will receive an initial clinic visit with a neuropsychiatrist and neurologists, identical to the initial clinic visit for the control group. In addition they will receive 1 session of motivational interviewing immediately following the initial clinic visit. These patients will be questioned using standardized motivational interviewing techniques by a board certified neurologist with formal training and certification in motivational interviewing.
Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at BWH or referred to a local psychotherapist according to their preference.
motivational interviewing: Motivational interviews will include the classical 4 steps of MI: 1) engagement; 2) focusing; 3) strengthening motivation; and 4) planning.
standard psychotherapy: Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES
|
|---|---|---|
|
Adherence
|
9 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Analysis population includes all participants for whom follow-up data was available. Patients who were lost to contact (after 7 phone calls and a mailed letter) for whom follow-up data was not available, were excluded from analysis.
Percent decrease in monthly PNES frequency
Outcome measures
| Measure |
Control
n=28 Participants
Group will receive standard treatment for psychogenic non-epileptic seizures. They will undergo an initial clinic visit with a neuropsychiatrist and neurologists. They will not undergo any subsequent motivational interview. Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at Brigham and Women's Hospital or referred to a local psychotherapist according to their preference.
standard psychotherapy: Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES
|
Motivational Interviewing
n=26 Participants
Group will receive an initial clinic visit with a neuropsychiatrist and neurologists, identical to the initial clinic visit for the control group. In addition they will receive 1 session of motivational interviewing immediately following the initial clinic visit. These patients will be questioned using standardized motivational interviewing techniques by a board certified neurologist with formal training and certification in motivational interviewing.
Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at BWH or referred to a local psychotherapist according to their preference.
motivational interviewing: Motivational interviews will include the classical 4 steps of MI: 1) engagement; 2) focusing; 3) strengthening motivation; and 4) planning.
standard psychotherapy: Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES
|
|---|---|---|
|
Percent Decrease in PNES Frequency
|
34.8 percentage of baseline seizures
Standard Deviation 89.7
|
76.2 percentage of baseline seizures
Standard Deviation 39.2
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Participants who provided this data at 4 month telephone follow-up.
Change from baseline number of Emergency Department visits per month.
Outcome measures
| Measure |
Control
n=28 Participants
Group will receive standard treatment for psychogenic non-epileptic seizures. They will undergo an initial clinic visit with a neuropsychiatrist and neurologists. They will not undergo any subsequent motivational interview. Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at Brigham and Women's Hospital or referred to a local psychotherapist according to their preference.
standard psychotherapy: Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES
|
Motivational Interviewing
n=26 Participants
Group will receive an initial clinic visit with a neuropsychiatrist and neurologists, identical to the initial clinic visit for the control group. In addition they will receive 1 session of motivational interviewing immediately following the initial clinic visit. These patients will be questioned using standardized motivational interviewing techniques by a board certified neurologist with formal training and certification in motivational interviewing.
Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at BWH or referred to a local psychotherapist according to their preference.
motivational interviewing: Motivational interviews will include the classical 4 steps of MI: 1) engagement; 2) focusing; 3) strengthening motivation; and 4) planning.
standard psychotherapy: Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES
|
|---|---|---|
|
Change in Number of Monthly Emergency Department Visits
|
0.06 ED visits per month
Standard Deviation 0.47
|
-0.15 ED visits per month
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Participants who provided information at 4 month telephone follow-up
Patients are classified as PNES free if they have had no PNES in 3 months, otherwise they are classified as not PNES free.
Outcome measures
| Measure |
Control
n=28 Participants
Group will receive standard treatment for psychogenic non-epileptic seizures. They will undergo an initial clinic visit with a neuropsychiatrist and neurologists. They will not undergo any subsequent motivational interview. Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at Brigham and Women's Hospital or referred to a local psychotherapist according to their preference.
standard psychotherapy: Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES
|
Motivational Interviewing
n=26 Participants
Group will receive an initial clinic visit with a neuropsychiatrist and neurologists, identical to the initial clinic visit for the control group. In addition they will receive 1 session of motivational interviewing immediately following the initial clinic visit. These patients will be questioned using standardized motivational interviewing techniques by a board certified neurologist with formal training and certification in motivational interviewing.
Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at BWH or referred to a local psychotherapist according to their preference.
motivational interviewing: Motivational interviews will include the classical 4 steps of MI: 1) engagement; 2) focusing; 3) strengthening motivation; and 4) planning.
standard psychotherapy: Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES
|
|---|---|---|
|
PNES Freedom
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Participants who provided QOLIE-10 information at 4-month follow-up
Change from baseline to 4 month follow-up, in quality of life in epilepsy (QOLIE)-10 score. Quality of Life in Epilepsy (QOLIE)-10 scale is a validated, reliable instrument measuring quality of life on a scale from 10 (best) to 50 (worst). Total score was used. No sub-scales were used.
Outcome measures
| Measure |
Control
n=23 Participants
Group will receive standard treatment for psychogenic non-epileptic seizures. They will undergo an initial clinic visit with a neuropsychiatrist and neurologists. They will not undergo any subsequent motivational interview. Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at Brigham and Women's Hospital or referred to a local psychotherapist according to their preference.
standard psychotherapy: Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES
|
Motivational Interviewing
n=24 Participants
Group will receive an initial clinic visit with a neuropsychiatrist and neurologists, identical to the initial clinic visit for the control group. In addition they will receive 1 session of motivational interviewing immediately following the initial clinic visit. These patients will be questioned using standardized motivational interviewing techniques by a board certified neurologist with formal training and certification in motivational interviewing.
Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at BWH or referred to a local psychotherapist according to their preference.
motivational interviewing: Motivational interviews will include the classical 4 steps of MI: 1) engagement; 2) focusing; 3) strengthening motivation; and 4) planning.
standard psychotherapy: Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES
|
|---|---|---|
|
Change in Quality of Life
|
1.8 units on QOLIE-10 scale
Standard Deviation 7.9
|
7.2 units on QOLIE-10 scale
Standard Deviation 10.0
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Motivational Interviewing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Benjamin Tolchin, MD, MS
Yale Comprehensive Epilepsy Center, Department of Neurology, Yale Univseristy School of Medicine
Phone: 347-721-8491
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place