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NCT Number: NCT07379723

Brief Intervention for FCD: A Feasibility Study

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.

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Key information

Conditions

Functional Cognitive Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief psychological intervention including attention training

Behavioral

Brief psychological intervention including attention training

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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).

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Registry information

Official study title

Feasibility Pilot Study of a Brief Intervention in Functional Cognitive Disorder

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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