Table 1.
Primary and secondary outcome measures and times of data collection
| Outcome variable/domain | Standardised measure/other | Putative moderators or mediators of treatment effects on clinical outcome | Clinical/economic outcomes | TO | T1 | T2 |
|---|---|---|---|---|---|---|
| PRIMARY OUTCOME | ||||||
| Seizure frequency | Seizure diary and self-report | X | X | X | X | |
| SECONDARY OUTCOMES | ||||||
| Seizures | Seizure severity; Two items measuring subjective severity (intensity) and bothersomeness from the Seizure Severity Scale [53] | X | X | X | X | |
| Longest period of seizure freedom between T1 & T2; seizure diary and self-report | X | X | ||||
| Seizure freedom for last 3 months of study; seizure diary and self-report | X | X | ||||
| >50 % reduction in seizure frequency; seizure diary and self-report | X | X | X | |||
| Informant’s rating of patient’s seizures; Rating as to whether participant’s seizures are better/same/ worse or whether they are seizure free | X | X | X | |||
| Health-related Quality of Life (QoL) | SF-12v2 (12-item measure of health-related QoL) [50] | X | X | X | X | |
| Psychosocial functioning | Work and Social Adjustment Scale (5-item scale to measure patients’ own perceptions of the impact of DS on their functioning in terms of work, home management, social leisure and private leisure activities, family and other relationships) [54] | X | X | X | X | |
| Avoidance of people, places and situations (3-item locally devised scale) | Mediator | X | X | X | ||
| Psychiatric symptoms and psychological distress | GAD7 (7-item scale to measure anxiety) [55] | X | X | X | X | |
| PHQ9 (9-item scale to measure depression) [56] | X | X | X | X | ||
| Modified PHQ15 (measure of other somatic symptoms) [57, 58] | X | X | X | X | ||
| CORE-10 (10-item scale; general measure of psychological distress including risk) [59] | X | X | X | X | ||
| 12-item Beliefs About Emotions Scale [42] | Mediator | X | X | X | ||
| Clinical impression of improvement | Clinical Global Impression (CGI) [28] Change score | X | X | X | ||
| Clinical Global Impression (CGI) [28] Change score rated by clinician (psychiatrist or neurologist) | X | X | ||||
| Clinical Global Impression (CGI) [28] Change score rated by CBT therapist at end of session 12 of CBT | X | |||||
| Satisfaction with treatment and beliefs relating to diagnosis and treatment | Single item measure of satisfaction with treatment | X | X | X | ||
| Belief in diagnosis of DS (single item; 11 point scale) | Mediator and/or moderator | X | X | X | ||
| Belief in having been given the correct treatment (single item; 11 point scale) | Mediator | X | X | X | ||
| Health economics | Client Service Receipt Inventory [46]: Formal and informal health service use | X | X | X | X | |
| EQ-5D-5L (5-item, 5 level measure) [49] | X | X | X | X | ||
| Linkage data setsa from Health and Social Care Information Centre (Hospital Episode Statistics) eDRIS (NHS National Services Scotland Information Services Division (ISD) and NHS Wales Informatics Service | X | X | X | X |
T0 = Baseline (prerandomisation) (face to face); T1 = 6 month follow-up (postal); T2 = 12 month follow-up (face-to face)
aAll data sought electronically