Feasibility randomised controlled trial of online group Acceptance and Commitment Therapy for Functional Cognitive Disorder (ACT4FCD)

Introduction Functional cognitive disorder is seen increasingly in clinics commissioned to assess cognitive disorders. Patients complain of frequent cognitive, especially memory, failures. The diagnosis can be made clinically, and unnecessary investigations avoided. While there is some evidence that psychological treatments can be helpful, they are not routinely available. Therefore, we have developed a brief psychological intervention using the principles of Acceptance and Commitment Therapy (ACT) that can be delivered in groups and online. We are conducting a feasibility study to assess whether the intervention can be delivered within a randomised controlled trial. We aim to study the feasibility of recruitment, willingness to be randomised to intervention or control condition, adherence to the intervention, completion of outcome measures, and acceptability of treatment. Methods and analysis We aim to recruit 48 participants randomised 50:50 to either the ACT intervention and Treatment as Usual (TAU), or TAU alone. ACT will be provided to participants in the treatment arm following completion of baseline outcome measures. Completion of these outcome measures will be repeated at 8, 16, and 26 weeks. The measures will assess several domains including psychological flexibility, subjective cognitive symptoms, mood and anxiety, health related quality of life and functioning, healthcare utilisation, and satisfaction with care and participant-rated improvement. Fifteen participants will be selected for in-depth qualitative interviews about their experiences of living with FCD and of the ACT intervention. Ethics and dissemination The study received a favourable opinion from the South East Scotland Research Ethics Committee 02 on 30th September 2022 (REC reference: 22/SS/0059). HRA approval was received on 1st November 2022 (IRAS 313730). The study has been registered with the ISRCTN ([ISRCTN12939037][1]). The results will be published in full in an open access journal. ISRCTN Registration Grant Number National Institute for Health and Care Research (NIHR) grant number: NIHR202743 Strengths and limitations of this study ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ISRCTN12939037 ### Clinical Protocols ### Funding Statement This study was funded by National Institute for Health and Care Research (NIHR). Grant number: NIHR202743 ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study received a favourable opinion from the South East Scotland Research Ethics Committee 02 on 30th September 2022 (REC reference: 22/SS/0059). HRA approval was received on 1st November 2022 (IRAS 313730). The study has been registered with the ISRCTN ([ISRCTN12939037][1]). The results will be published in full in an open access journal. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors [1]: /external-ref?link_type=ISRCTN&access_num=ISRCTN12939037