Functional cognitive disorder Mental and Behavioural Disorders
Conditions
Interventions
Simple randomisation is provided by King’s Clinical Trials Unit. Participants will be randomised to either the ACT group intervention (Condition A) or a control group (Condition B). The intervention i
TAU will have been provided for subjects in Condition B)
T2: At week 16 post-randomisation (group and booster sessions will have been completed in Condition A
at 3-4 months post TAU in Condition B)
T3: At week 26 post-randomisation
Proposed clinical outcome measures:
Acceptance and Action Questionnaire II
Self-evaluation of Memory Systems Questionnaire
P
Sponsors
South West London and St George's Mental Health NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. An established diagnosis of FCD made in DMC/CNC and confirmed by the research team 2. Aged 18 years or over 3. Capacity to provide written informed consent 4. MMSE score =25
Exclusion criteria
Exclusion criteria: 1. Disabling cognitive symptoms in the context of a primary psychiatric disorder (e.g., depression, severe generalised anxiety disorder, schizophrenia) 2. Greater than mild-moderate depressive or anxiety disorders (PHQ9 score =15 and/or GAD7 score =15) 3. At “medium” or “high” risk of deliberate self-harm and/or suicide (based on RiO electronic medical records structured risk assessment form) 4. Another predominant functional disorder (e.g., functional seizures) 5. Diagnosis of dementia 6. Diagnosis of learning disability 7. Insufficient command of English to engage without an interpreter
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The acceptability of the intervention and the feasibility of conducting a definitive RCT to test efficacy, assessed using the following outcomes: 1. Rates of referral (% of total seen in DMC during study recruitment period; data source: electronic patient records), eligibility (% of those referred meeting inclusion criteria; data source: study database) and enrolment (% of those eligible who agree to participate; data source: study database). Measured over the course of the study and reported at the end using descriptive statistics 2. Clinical and sociodemographic characteristics of ineligible and non-consenting subjects measured using the study database over the course of the study and reported at the end using descriptive statistics 3. Intervention adherence (% of starters who complete =4/5 group sessions) measured using the study database over the course of the intervention period and reported at the end using descriptive statistics 4. Intervention acceptability (% satisfied/very satisfied measured with a five-point Likert satisfaction scale and thematic analysis of qualitative responses from one-to-one interviews), measured over the course of the intervention period and reported at the end using descriptive statistics. Acceptability also explored using qualitative methodology during the intervention period 5. Intervention fidelity measured using the Acceptance and Commitment Therapy Fidelity Measure during ACT sessions selected at random over the course of the intervention period and reported at the end using descriptive statistics 6. Intervention safety (% and description of adverse events and serious adverse events in Conditions A and B) measured using the study database over the course of the study and reported at the end using descriptive statistics 7. Appropriateness and acceptability of clinical outcome measures (by thematic analysis of qualitative responses from one-to-one interviews) explored using qualitative methodology during and after the interventio | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 07/11/2022: 1. Psychological flexibility is measured using the Acceptance and Action Questionnaire II (AAQ-II) at baseline, 8 weeks, 16 weeks, and 26 weeks 2. Self-appraisal of memory functioning is measured using the Acceptance Multifactorial Memory Questionnaire (MMQ) at baseline, 8 weeks, 16 weeks, and 26 weeks 3. General level of distress and day-to-day functioning is measured using the World Health Organisation Disability Assessment Schedule (WHODAS 2.0) at baseline, 8 weeks, 16 weeks, and 26 weeks 4. Health-related quality of life is measured using the EQ-5F-5L at baseline, 8 weeks, 16 weeks, and 26 weeks 5. Level of depression is measured using the PHQ-9 at baseline, 8 weeks, 16 weeks, and 26 weeks 6. Level of anxiety is measured using the GAD-7 at baseline, 8 weeks, 16 weeks, and 26 weeks 7. Service utilisation is assessed using the Adult Service Use Schedule (AD-SUS) at baseline and again at 26 weeks 8. Assessment of non-health benefits is measured using the ICEpop CAPability measure for Adults (ICECAP-A) at baseline, 8 weeks, 16 weeks, and 26 weeks 9. Self-reported improvement at the end of the study period is assessed using the Clinical Global Impression – Global Improvement (CGI –I) Scale (self-report), at 26 weeks 10. Satisfaction with the interventions offered (Treatment as Usual and ACT) assessed using a Likert 5-point satisfaction with treatment scale at 16 weeks Previous secondary outcome measures: 1. Psychological flexibility measured using the Acceptance and Action Questionnaire II (AAQ-II) at baseline, 8, 16 and 26 weeks 2. Metacognition (perception of own memory functioning) measured using the Self-evaluation of Memory Systems Questionnaire (SMSQ) at baseline, 8, 16 and 26 weeks 3. Mood and anxiety measured using the Patient Health Questionnaire-9 (PHQ9) and Generalised Anxiety Disorder 7-item (GAD7) scales at baseline, 8, 16 and 26 weeks 4. Level of disability measured by the WHO Disability Assessment S | — |
Countries
England, United Kingdom
Outcome results
None listed