Purpose <p>Transcranial direct current stimulation (tDCS) is a novel non-invasive brain stimulation therapy that is a potential treatment for major depressive disorder (MDD). Acceptability impacts patient preference, treatment adherence and outcomes, however, it has typically been assessed through measures of attrition, self-reported satisfaction levels, or adverse events. We sought to explore participant acceptability using structured questionnaires and individual interviews.</p> Methods <p>Acceptability was assessed in a fully remote, multisite, double-blind, placebo-controlled, randomized superiority trial of a 10-week course of home-based tDCS for MDD. Questionnaires were conducted at baseline and at the 10-week end of treatment. Participants were 174 adults (120 women) with MDD in a current depressive episode of at least moderate severity. Active or sham tDCS was self-administered over 10 weeks with remote supervision at regular intervals. A thematic analysis was conducted.</p> Results <p>Four themes were revealed: acceptability, ease of use, side effects, and trial participation. The themes indicated generally high acceptability of tDCS as a treatment of MDD in both the active and sham treatment groups. Some participants noted concerns about the technical functionality of the device and the impact of side effects.</p> Conclusions <p>The first three themes are central to understanding participant perspectives of tDCS and its feasibility as a treatment option. In addition, the theme of trial participation highlights the value of participant support when introducing a new treatment, which may underscore treatment options in general. Furthermore, acceptability is a dynamic concept as participant views changed during treatment.</p> Trial registration <p>NCT05202119, registered on 9th January 2022.</p>

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Acceptability of active and sham home-based transcranial direct current stimulation in major depression: mixed methods qualitative analysis in a randomised controlled trial

  • Peter J. Lagerberg,
  • Rachel D. Woodham,
  • Sudhakar Selvaraj,
  • Nahed Lajmi,
  • Harriet Hobday,
  • Gabrielle Sheehan,
  • Ali-Reza Ghazi-Noori,
  • Maheen Rizvi,
  • Sarah S. Kwon,
  • Paulette Orhii,
  • Rodrigo Machado-Vieira,
  • Jair C. Soares,
  • Allan H. Young,
  • António R. Fidalgo,
  • Hakimeh Rezaei,
  • Cynthia H. Y. Fu

摘要

Purpose

Transcranial direct current stimulation (tDCS) is a novel non-invasive brain stimulation therapy that is a potential treatment for major depressive disorder (MDD). Acceptability impacts patient preference, treatment adherence and outcomes, however, it has typically been assessed through measures of attrition, self-reported satisfaction levels, or adverse events. We sought to explore participant acceptability using structured questionnaires and individual interviews.

Methods

Acceptability was assessed in a fully remote, multisite, double-blind, placebo-controlled, randomized superiority trial of a 10-week course of home-based tDCS for MDD. Questionnaires were conducted at baseline and at the 10-week end of treatment. Participants were 174 adults (120 women) with MDD in a current depressive episode of at least moderate severity. Active or sham tDCS was self-administered over 10 weeks with remote supervision at regular intervals. A thematic analysis was conducted.

Results

Four themes were revealed: acceptability, ease of use, side effects, and trial participation. The themes indicated generally high acceptability of tDCS as a treatment of MDD in both the active and sham treatment groups. Some participants noted concerns about the technical functionality of the device and the impact of side effects.

Conclusions

The first three themes are central to understanding participant perspectives of tDCS and its feasibility as a treatment option. In addition, the theme of trial participation highlights the value of participant support when introducing a new treatment, which may underscore treatment options in general. Furthermore, acceptability is a dynamic concept as participant views changed during treatment.

Trial registration

NCT05202119, registered on 9th January 2022.