Functional Cognitive DisorderNCT07379723
Brief Intervention for FCD: A Feasibility Study
A study testing Brief psychological intervention including attention training in people with Functional Cognitive Disorder, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Functional Cognitive Disorder
- What is being tested?
- Brief psychological intervention including attention training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Nov 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Aged above 65 years
- Lack capacity to consent
- MRI results not in normal range
- Neurological diagnosis
- Indication of severe low mood or depression (from clinical interview, routine measures)
- Taking part in any other intervention study or trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College Hospital
London
Kendra Shaw, +4420 3299 8330, kendra.shaw@nhs.net
About this study
Official title: Feasibility Pilot Study of a Brief Intervention in Functional Cognitive Disorder
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?
Read more
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.
- Conditions
- Functional Cognitive Disorder
- Being tested
- Brief psychological intervention including attention training
- Keywords
- Functional Cognitive Disorder, Brief Interventions, Feasibility, Pilot, Attention Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief psychological intervention including attention trainingBehavioural
Brief psychological intervention including attention training
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Brief psychological intervention including attention training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to follow-up 6 weeks post-intervention.
Secondary outcomes (6)
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).
Measured: Post-intervention follow-up at 6 weeks.
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)
Measured: At enrolment and at follow-up 6 weeks post-intervention
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)
Measured: At enrolment and at follow-up 6 weeks post-intervention
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)
Measured: At enrolment and at follow-up 6 weeks post-intervention
Change in quality of life from enrolment to post-intervention follow-up
Participants will complete questionnaire at enrolment and at follow-up post-intervention:
- EuroQol 5-Dimension 5-Level (EQ-5D-5L)(Herdman et al., 2011)
Measured: At enrolment and at follow-up 6 weeks post-intervention
Change in self-reported cognitive symptoms from enrolment to post-intervention follow-up
Participants will complete questionnaire at enrolment and at follow-up post-intervention:
- The Cognitive Failures Questionnaire 2.0(Goodhew \& Edwards, 2024).
Measured: At enrolment and at follow-up 6 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start11 Nov 2025
- Primary completion13 Mar 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Cognitive DisorderStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379723
- Sponsor's protocol ID
- IRAS Reference: 354504
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Pilot Study of a Brief Intervention in Functional Cognitive Disorder
- ClinicalTrials.gov ID
- NCT07379723
- Acronym / sponsor ID
- IRAS Reference: 354504
- Conditions
- Functional Cognitive Disorder
- Keywords
- Functional Cognitive Disorder, Brief Interventions, Feasibility, Pilot, Attention Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 13 Mar 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Brief psychological intervention including attention training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Aged above 65 years
- Lack capacity to consent
- MRI results not in normal range
- Neurological diagnosis
- Indication of severe low mood or depression (from clinical interview, routine measures)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief psychological intervention including attention trainingBrief psychological intervention including attention training | Behavioural | Intervention |
Primary outcome
Participant recruitment, feasibility and retention from baseline to follow-up
Time frame: From enrollment to follow-up 6 weeks post-intervention.
• Number of participants recruited and retention rate (number and percentage of participants completing post-intervention measures) will be recorded.
6 secondary outcomes
Acceptability of the study intervention at follow-up
Time frame: Post-intervention follow-up at 6 weeks.
Change in symptoms of depression from enrolment to post-intervention follow-up
Time frame: At enrolment and at follow-up 6 weeks post-intervention
Change in symptoms of anxiety from enrolment to post-intervention follow-up
Time frame: At enrolment and at follow-up 6 weeks post-intervention
Change in functional impairment from enrolment to post-intervention follow-up
Time frame: At enrolment and at follow-up 6 weeks post-intervention
Change in quality of life from enrolment to post-intervention follow-up
Time frame: At enrolment and at follow-up 6 weeks post-intervention
Change in self-reported cognitive symptoms from enrolment to post-intervention follow-up
Time frame: At enrolment and at follow-up 6 weeks post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief psychological intervention including attention training in people with Functional Cognitive Disorder, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant recruitment, feasibility and retention from baseline to follow-up (time frame: From enrollment to follow-up 6 weeks post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.