Formulation and Brief-ACT for FND
Research type
Research Study
Full title
Effectiveness and Acceptability of Formulation and Brief-ACT intervention for Functional Neurological Disorders
IRAS ID
311583
Contact name
Warren Dunger
Contact email
Sponsor organisation
University of Southampton
ISRCTN Number
ISRCTN48373551
Duration of Study in the UK
0 years, 7 months, 29 days
Research summary
Research Summary
Functional Neurological Disorder (FND) is a highly prevalent disorder and individuals with this condition have substantial delays in diagnosis. This can prevent individuals from developing an understanding of their condition and accessing appropriate treatment. Emerging evidence suggests that a formulation, explanation of their condition, can result in improved quality of life and even reduced symptom frequency. Acceptance and Commitment Therapy (ACT) has been shown to also improve quality of life, mood and symptom interference in individuals with FND and similar conditions. This therapeutic model focuses on helping people to live well despite the difficulties they are experiencing. Currently, the evidence is limited but promising in FND population using formulation and ACT as separate treatment options. Therefore, study will combine both of these approaches to assess the effectiveness and acceptability of this treatment in individuals with FND. This study will use a small scaled experimental phased design, lasting 15 weeks. In that time participants will receive 5 sessions that will include a clinical interview, a formulation and 3 ACT bases sessions. Participants will be required to complete questionnaires throughout the study.
Individuals eligible for participation must have an official FND diagnosis, 18+ years old, a good understanding of English. This study will take place in Dorset Healthcare University NHS Foundation Trust, Adult Neuropsychology Service.Summary of Results
The study was carried out by a trainee clinical psychologist, Irma Konovalova, under the supervision of two Clinical Neuropsychologists, Dr Warren Dunger and Dr Birgit Gurr (Consultant). The study sponsor is the University of Southampton.
The study took place in Poole, Dorset, between November 2022 and July 2023.
Functional Neurological Disorder (FND) is a common neuropsychiatric condition that affects about 50, 000 to 100, 000 people in the community in the UK. Its symptoms can mimic other neurological disorders, such as tremors and spasms, abnormal movements and/or episodes of altered consciousness, or cognitive difficulties. For some people these symptoms can be mild and for others long-lasting and debilitating.
Why was the research needed?Currently, there is a lack of services that provides psychological support to people with FND. We know from recent evidence that people with FND benefit from a clear explanation of their symptoms, considering factors that may have contributed to developing this condition. Also, thinking about what may have triggered the development and what might keep the symptoms going. However, that evidence is limited.
We also know that symptom reduction is not always possible in FND. There is a lack of therapies that promote personally meaningful, value based functioning despite the symptom presence. This is the overarching goal of Acceptance and Commitment Therapy. Evidence suggests that ACT is effective at improving mood, quality of life and even symptom impact in similar conditions like persistent pain, chronic fatigue and fibromyalgia.
Therefore, this study aimed to combine the formulation and brief ACT as an intervention for people with FND. We aimed to evaluate its acceptability and effectiveness.
What were the main questions studied?
We wanted to establish if this intervention is safe for people with FND.If this intervention reduced the distress of FND symptoms and their impact on engagement in daily activities.
If this intervention increased psychological health, emotional processing and quality of life in people with FND.
If there was an effect on symptom reduction as a result of this intervention.
Who participated in the study?
In total 6 people with a diagnosis of Functional Neurological Disorder were recruited to the study, however only 4 participants started and completed the full intervention.What treatments or interventions did the participants take/receive?
The intervention included five sessions consisting of a clinical interview, a formulation session and three sessions of Acceptance and Commitment Therapy (ACT). The formulation session focused on developing a collaborative understanding about their illness. The ACT sessions included development of different coping strategies.What medical problems (adverse reactions) did the participants have?
No medical problems or adverse reactions were experienced.What happened during the study?
Participants attended a community clinic for their appointments or had the option to attend online. They also had to fill in questionnaires at four time points and complete a three question survey every other day for the length of the intervention.What were the results of the study?
This intervention was safe and well accepted by people with FND. After the intervention, participants were able to engage in more meaningful activities despite their FND symptoms. They also experienced less distress about their FND symptoms. We also observed symptom reduction during the intervention. There was also an improvement in psychological health and emotional processing for most participants. Therefore, we concluded that this brief intervention was effective for people with FND.How has this study helped patients and researchers?
The patients provided positive feedback following the intervention. They received an intervention that otherwise would have not been available to them. This study has contributed to the wider evidence based in FND research.
Has the registry been updated to include summary results?: No
If yes - please enter the URL to summary results:
If no – why not?: It will be made available by the 31/12/2023
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Pending
If yes, describe or provide URLs to disseminated materials:
If pending, date when dissemination is expected: 31/07/2024
If no, explain why you didn't follow it:
Have participants been informed of the results of the study?: Pending
If yes, describe and/or provide URLs to materials shared and how they were shared:
If pending, date when feedback is expected: 13/01/2024
If no, explain why they haven't:
Have you enabled sharing of study data with others?: Yes
If yes, describe or provide URLs to how it has been shared: It is available via the university repository
If no, explain why sharing hasn't been enabled:
Have you enabled sharing of tissue samples and associated data with others?: No
If yes, describe or provide a URL:
If no, explain why: N/AREC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
22/NW/0320
Date of REC Opinion
4 Nov 2022
REC opinion
Further Information Favourable Opinion