Brief Intervention for FCD: A Feasibility Study
ConditionFunctional Cognitive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKing's College Hospital NHS Trust
About this trial
The goal of this study is to learn if a single session intervention for people with Functional Cognitive Disorder (FCD) is feasible and acceptable. The main questions it aims to answer are:
What is the impact of a single session intervention on FCD symptoms, functional impairment, and quality of life in people with FCD?
What is the feasibility and acceptability of piloting a single session intervention for people with FCD.
Participants will:
* Complete questionnaires about cognitive concerns, anxiety, depression, functional impairment and quality of life * Visit the clinic for a single session intervention including practicing the Attention Training Technique (ATT) * Complete 2 telephone calls with a researcher to discuss their use of the intervention and to complete the same questionnaires from their clinic visit, and a questionnaire about their experience of the study and intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 65 or below
Meet criteria for diagnosis of FCD (criteria include normal MRI results with no neurological diagnosis, and symptoms that are not explained by any other medical condition, performance at routine pre-baseline neuropsychological assessment within the service)
Not taking part in any other intervention study or trial
Disqualifiers
Aged above 65 years
Lack capacity to consent
MRI results not in normal range
Neurological diagnosis
Trial design
Design model
Single group
Treatments tested in this trial
Brief psychological intervention including attention training
BehavioralBrief psychological intervention including attention training
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Participant recruitment, feasibility and retention from baseline to follow-up
• Number of participants recruited and retention rate (number and percentage of participants completing post-intervention measures) will be recorded.
Time frame
From enrollment to follow-up 6 weeks post-intervention.Secondary outcomes
1
Acceptability of the study intervention at follow-up
• At follow-up, participants will complete a questionnaire to collect information on acceptability of the study and intervention (Theoretical framework of acceptability \[TFA\] questionnaire; Sekhon et al., 2022).
Time frame
Post-intervention follow-up at 6 weeks.2
Change in symptoms of depression from enrolment to post-intervention follow-up
Participants will complete questionnaire at enrolment and at follow-up post-intervention: • Patient Health Questionnaire 9 (PHQ-9) (Kroenke et al., 2001)
Time frame
At enrolment and at follow-up 6 weeks post-intervention3
Change in symptoms of anxiety from enrolment to post-intervention follow-up
Participants will complete questionnaire at enrolment and at follow-up post-intervention: • Generalised Anxiety Disorder 7 questionnaire (GAD- 7) (Spitzer et al., 2006)
Time frame
At enrolment and at follow-up 6 weeks post-intervention4
Change in functional impairment from enrolment to post-intervention follow-up
Participants will complete questionnaire at enrolment and at follow-up post-intervention: • Work and Social Adjustment Scale (WSAS) (Mundt et al., 2002)
Time frame
At enrolment and at follow-up 6 weeks post-interventionSponsors and contacts
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Source ClinicalTrials.gov