Document is current

Article History

Received: 11 August 2023

Accepted: 15 February 2024

First Online: 1 March 2024

Declarations

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: Trial participants are recruited from individuals who consented to a survey study on university students’ mental health, approved by the Swedish National Ethical Review Authority, ref. nr. 2020–01465, May 12, 2020, with approved amendments 2020–02706, June 16, 2020, 2020–04639, Oct 12, 2020, 2023–02378-02, May 6, 2023, 2023–02393-02, May 15, 2023, and 2023–07621-02, December 27, 2023. The electronic consent form for the survey study specifically requests consent to survey participation and, separately, requests consent to linking of survey data with educational registry outcomes (the Swedish Ladok system). The study information includes a statement that survey study participants may be invited to future treatment and qualitative studies. The survey also includes a question at the end asking whether participants would be interested in participating in a treatment study in the future. Ethical documents pertaining to the survey study are available upon reasonable request.Survey study participants who have given their consent and have completed the survey are invited to participate in the randomized controlled trial reported in this protocol. The randomized controlled trial reported in this protocol was approved by the Swedish National Ethical Review Authority, ref. nr. 2021–03599, Sept. 15, 2021. An amendment, nr 023_05477_02, was approved on Oct 2, 2023. The electronic consent form for the randomized controlled trial specifically requests consent to trial participation and, separately, consent to linking of trial data with educational registry outcomes (the Swedish Ladok system). Ethical documents pertaining to the randomized controlled trial described in this protocol are attached as supplementary material.

: All participants in both the survey study and the RCT have consented to participation and been informed that group-level data will be published such that no individual can be identified. The same applies to any qualitative data published. Participants in the RCT have provided consent in four ways: (1) consent to respond to the survey study; (2) consent to link their survey response data to data on educational outcomes, shared by the national educational registry for consenters; (3) consent to participate in the RCT, including the SWAT; (4) consent to link their RCT outcome data to data on educational outcomes, shared by the national educational registry for consenters.Regarding the necessary period for deliberation over taking part in the RCT, the recruitment takes place over several days. First, participants are invited to the RCT, and given 1 week to respond if they wish. Participants who click on the RCT survey invitation link are given detailed study information, followed by consent queries 3 and 4 (see paragraph immediately preceding this one). Those who provide their informed consent by answering “yes” to item 3 proceed to access the treatment eligibility survey, regardless of their response to item 4. Those who do not provide their informed consent are automatically thanked for their interest and proceed no further. Educational registry data will be accessed at a later date following conclusion of the trial, and such data will only be requested for participants who have provided their informed consent in item 4.

: MB owns a private company (Alexit AB) that maintains and distributes evidence-based digital lifestyle interventions to be used by the public and in health care settings. AHB owns a private company (Otimus AB) that offers psychotherapy in private practice. Neither Alexit AB nor Otimus AB played any role in developing the intervention, study design, data analysis, data interpretation, or writing of this report. All other authors declare that they have no competing interests.