| Cohort Name |
COgnitive behavioural therapy vs. standardised medical care for adults with Dissociative non-Epileptic Seizures: a multicentre randomised controlled trial |
| Cohort Acronym |
CODES |
| Study Overview |
This study examined the clinical and cost-effectiveness of dissociative-seizure specific cognitive behavioural therapy plus standardised medical care vs standardised medical care alone for adults with dissociative seizures. This clinical trial randomised patients from a larger pool of patients with dissociative seizures recruited in neurology/epilepsy clinics in the UK. |
| #Subjects at Baseline |
368 completed baseline assessments and were randomised to the RCT. |
| Institution Name |
King's College London |
| Department Name |
Psychology |
| City |
London |
| Study/Database Website |
Study website www.codestrial.org |
| Principal Investigator (PI) |
Prof Laura Goldstein |
| Key Study References |
Goldstein LH, Mellers JDC, Landau, S, Stone J, Carson A, Medford N, et al. Cognitive behavioural
therapy vs standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES):
a multicentre randomised controlled trial protocol. BMC Neurol 2015;15:98.
Robinson EJ, Goldstein LH, McCrone P, Perdue I, Chalder T, Mellers JDC, et al. Cognitive behavioural
therapy versus standardised medical care for adults with dissociative non-epileptic seizures (CODES):
statistical and economic analysis plan for a randomised controlled trial. Trials 2017;18:258.
Goldstein LH, Robinson EJ, Mellers JDC, Stone J, Carson A, Reuber M, et al. Cognitive behavioural
therapy for adults with dissociative seizures (CODES): a pragmatic, multicentre, randomised controlled trial. Lancet Psychiatry 2020;7:491–505.
Goldstein LH, Robinson EJ, Pilecka I, Perdue I, Mosweu I, Read J, et al. Cognitive–behavioural
therapy compared with standardised medical care for adults with dissociative non-epileptic
seizures: the CODES RCT. Health Technol Assess 2021;25(XX).(in press) |
| Population Based Study? |
No |
| Family Based Study? |
No |
| Clinical based sample? |
Yes |
| Is there follow-up data available? |
As part of the study |
| Were participants included prior to development of dementia (may refer to controls only)? |
N/a |
| Were participants included prior to development of MCI (may refer to controls only)? |
N/a |
| How is data collected? |
It was collected either by post or face-to-face |
| Who carries out data collection? |
Research workers |
| Does this take place in participants' homes or at a central location? |
Location varied; at home or in hospital settings when face to face |
| Do participants take part individually or are families/partners involved? |
Participants took part individually; some data is from clinicians |
| Dementia cases ascertained as part of study: |
N/a |
| How many times followed up? |
Twice post randomisation (at 6 and 12 months) |
| Study start date |
01.06.2014 |
| Study end date |
31.03.2020 (end of grant; 10.12.2019 end of study decleration to NRES). |
| Is study ongoing? |
No |
| Is study still recruiting? |
No |
| Inclusion criteria |
Inclusion criteria (for the initial screening phase from wich RCT patients randomised)
a) Adults aged at least 18 years who had experienced DSs within the previous 8 weeks and
whose diagnosis was corroborated by either video encephalography telemetry or, if not available,
clinical consensus .
b) Adults with no recorded history of intellectual disability.
c) Adults able to keep seizure diaries and fill out questionnaires.
d) Adults who showed willingness to keep seizure diaries on a regular basis and attend a psychiatric
assessment 3 months following receipt of their DS diagnosis in the study.
e) Adults who were able to provide informed consent. Inclusion criteria for randomised controlled trial (intervention phase for which data are provided)
a) Adults aged ≥ 18 years who had been recruited into the study in the screening phase following
their diagnosis.
b) Adults who were willing to continue filling out seizure diaries and complete questionnaires.
c) Adults who had provided data about their seizure occurrence on a regular basis since receiving their diagnosis of DSs in the screening phase.
d) Adults who indicated that if they were randomsied to CBT, they would be willing to attend weekly or fortnightly therapy sessions.
e) Both the participant and their clinician believed that randomisation was acceptable.
f) Adults who had the ability to provide written informed consent. |
| Exclusion criteria |
Exclusion criteria (screening phase from which randomisation then occurred)
a) A diagnosis of currently occurring epileptic seizures in addition to DSs (‘current’ was defined as
an epileptic seizure occurring in the previous year).
b) Adults lacking the ability to independently maintain seizure records or complete questionnaires.
c) Adults who met criteria for current alcohol or drug dependency in line with the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
d) Adults who were insufficiently fluent in English to complete questionnaires or later undergo CBT without the aid of an interpreter.
e) Adults currently receiving cognitive behavioural therapy (CBT) for another diagnosis, if this intervention would still be ongoing by the time the assessment by the psychiatrist took place.
f) Adults who previously had a CBT-based treatment for dissociative seizures at one of the centres taking part in the trial. Exclusion criteria for randomised controlled trial
a) Adults who were currently experiencing epileptic seizures in addition to dissociative seizures
b)Adults who had not experienced a dissociative seizure during the 8-week period leading up to the psychiatry assessment.
c) Adults who had previously received a CBT-based intervention for dissociative seizures at one of the centres participating in the RCT.
d) Adults who were currently receiving a CBT intervention for another disorder.
e) Adults who were experiencing an active psychosis.
f) Adults who met criteria for current alcohol or drug dependence according to DSM-IV criteria
g) Evidence of current use of benzodiazepines greater than the equivalent dose of 10 mg of
diazepam per day.
h) Adults at high risk of imminent self-harm following the psychiatry assessment or according to the
results of a structured psychiatric assessment [the Mini-International Neuropsychiatric Interview] administered by the research worker, subsequently followed up by a discussion with the relevant psychiatrist.
i) Adults who had received a diagnosis of factitious disorder. |