Brief Intervention for FCD: A Feasibility Study

January 23, 2026 updated by: King's College Hospital NHS Trust

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?

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Behavioral: Brief psychological intervention including attention training
Brief psychological intervention including attention training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to follow-up 6 weeks post-intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of the study intervention at follow-up
Time Frame: Post-intervention follow-up at 6 weeks.
• 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).
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

Participants will complete questionnaire at enrolment and at follow-up post-intervention:

• Patient Health Questionnaire 9 (PHQ-9) (Kroenke et al., 2001)
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

Participants will complete questionnaire at enrolment and at follow-up post-intervention:

• Generalised Anxiety Disorder 7 questionnaire (GAD- 7) (Spitzer et al., 2006)
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

Participants will complete questionnaire at enrolment and at follow-up post-intervention:

• Work and Social Adjustment Scale (WSAS) (Mundt et al., 2002)
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

Participants will complete questionnaire at enrolment and at follow-up post-intervention:

• EuroQol 5-Dimension 5-Level (EQ-5D-5L)(Herdman et al., 2011)
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

Participants will complete questionnaire at enrolment and at follow-up post-intervention:

• The Cognitive Failures Questionnaire 2.0(Goodhew & Edwards, 2024).
At enrolment and at follow-up 6 weeks post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College Hospital NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2025

Primary Completion (Estimated)

March 13, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

January 30, 2026

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRAS Reference: 354504

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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