Document is current

Article History

Received: 13 May 2022

Accepted: 25 August 2022

First Online: 12 September 2022

Declarations

:

: The study received full ethical approval on January 11, 2022, from the North West – Greater Manchester East Research Ethics Committee, Research Ethics Committee (REC) REC ref: 21/NW/032, IRAS ID 296079. The trial has been registered in ExternalRef removed (NCT05260060) and ISRCTN (ISRCTN18335255). The study protocol used was version 4: 24.03.2022. Any modifications to the trial will be submitted for further ethical approval, and approved changes will be documented and communicated to the REC, trial registry, executive committee, and all relevant parties. The study will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki (1996), the principles of Good Clinical Practice, and the UK Policy Framework for Health and Social Care Research (2017). GMMH acts as the sponsor for this study. As the sponsor is an NHS organisation, the NHS indemnity scheme will apply<i>.</i> Participating sites will be liable for clinical negligence and other negligent harm to participants taking part in the study and covered by the duty of care owed to them by the sites concerned.Written informed consent will be obtained from all participants and their parents/caregivers. Participants will be free to withdraw from the study at any time without providing a reason or their care being impacted. All the information collected during this trial will be confidential and held in accordance with NHS Data Protection guidelines and Good Clinical Practice guidelines. Confidentiality will only be breached if participants disclose information which may indicate that there is a risk of harm to themselves or others. Every opportunity to discuss any possible breaches of confidentiality with participants will be taken prior to informing any appropriate agencies, e.g. CAMHS staff, GP, or A&E services.All researchers and study site staff involved with the study must comply with the requirements of the Data Protection Act 1998 regarding the collection, storage, processing, and disclosure of personal information and will uphold the Act’s core principles. Audio recordings and transcriptions of interviews will be stored on NHS drives, which are password protected and designed for the storage of confidential research material. Interviews which are transcribed will be anonymised at the point of transcription. Any third party involved with transcribing of interviews will sign a confidentiality agreement and be fully instructed in how to anonymise transcripts.

: Not applicable.

: AW is the creator of Metacognitive Therapy and co-director of the MCT Institute.