Description

Ethical Approval:

The study received ethical approval from the Regional Committees for Medical and Health Research Ethics - South-East D (REK sør-øst D) in Norway, under reference number 790305.

Quality Assurance and Data Management:

The proposed study will not use any registry data and instead collect data with validated questionnaires. Questionnaires will be filled in during interviews with the NET therapist, which will increase data quality by ensuring that participants understand the questions and are engaged in answering them. The questionnaires were translated to Ukrainian by the Trauma Consortium, which helps to ensure both quality and understanding from both patients and health workers. Questionnaire data will be coded in accordance with the published manuals for the respective questionnaires, and a data dictionary will be used to describe each variable according to the manuals.

All data, including notes from NET sessions and the resulting narratives, will be stored on a secure server, TSD (link to the website can be found in the reference list). Questionnaire data will be collected with a secure and anonymous data collection tool, Nettskjema (link to the website can be found in the reference list), and will be directly transferred to TSD. The study will also include a link key, stored in TSD, that links the participant's name to an anonymous code, and the anonymous code to the dataset, so that data will not be stored together with the participants' names. The data management in the current study has been assessed with a Data Protection Impact Assessment (DPIA) and has been approved by the Norwegian Agency for Shared Services in Education and Research, SIKT (link to the website in the reference list) and the Norwegian Regional Committee for Medical and Health Research Ethics, REK (link to the website can be found in the reference list).

REK also approved an emergency procedure for handling cases where participants score highly on depression or suicidal thoughts. The procedure includes a psychoeducative conversation with the participants by the project's PI (Vanessa Nolasco Ferreira) and the offer to send a letter to the participant's General Practitioner, with information about the depression and/or suicidal thoughts score. This letter will allow the GP to refer the participant to the specialized mental health services and reduce waiting times for treatment.

Sample Size Assessment:

A convenience sampling approach will be utilized, with the final sample size depending on the number of individuals who volunteer and meet the inclusion criteria. This approach accommodates variability in participant availability and willingness. The project has financial resources for NET training of 25 health workers, and each health worker needs to conduct supervised NET with two participants as part of the practical training that is necessary for NET certification. We are therefore aiming at 50 participants (25 in the intervention group and 25 in the waitlist control group). Previous NET interventions in similar populations have shown significant effects with comparable or considerably smaller sample sizes.

Plan for Missing Data:

The dropout rate during NET interventions tends to be low or zero, partially due to the short duration of interventions. Therefore, we expect minimal risk of missing datasets at post-treatment assessments. There might be a slightly higher risk for missing datasets at 6-months follow-up. We will compare demographic data and initial post-treatment effects of any dropouts with data of participants that complete the follow-up assessment, in order to evaluate potential biases due to systematic differences between dropouts and completers. There is no risk of missing data due to incomplete questionnaires (i.e. participants accidentally not answering single items) since the software used for assessment does not allow submission of the questionnaire unless all items are answered.