Sex and gender reporting in RCTs of internet and mobile-based interventions for depression and anxiety in chronic conditions: A secondary analysis of a systematic review

Abstract

Mind-body internet- and mobile-based intervention (IMIs) are gaining traction as scalable and effective strategies to manage mental health symptoms experienced by people living with chronic physical conditions. Sex and gender have implications for mind-body IMI participation, adherence, and efficacy. The objective of this secondary analysis was to assess the extent and nature of reporting of sex and/or gender in randomized controlled trials retrieved by a primary systematic review of mind-body IMIs assessing depression and anxiety symptoms among adults living with chronic physical conditions. The collected information included whether sex and gender-based analyses were carried out and explored the role of sex and gender on mental health outcomes, attrition, and recruitment rates. The protocol was registered with PROSPERO. A comprehensive search of six electronic databases was completed from database inception to March 2023. Sex and gender terms were summarized according to a standardized, three-point criteria: (1) non-binary use (i.e., > 2 categories used for both sex and gender definitions) (2) use of appropriate categories (i.e., sex = male/female/intersex, gender = man/woman/gender-diverse) and (3) non-interchangeable use of sex or gender terms throughout the citation. The use of sex and gender terms was deemed correct if all three criteria were met. The role of sex and gender on mental health outcomes, attrition and recruitment data were extracted where available. In the 56 included studies, 7691 participants were evaluated with a mean age of 43 years and 4780 (62%) were described as females/women. Two (4%) studies defined sex or gender using non-binary categorization. Twenty-eight (50%) studies used appropriate categories to define sex or gender. Twenty-five (45%) studies used sex and gender terms non-interchangeably. No studies met all three sex/gender criteria. Only one study provided stratified mental health scores by sex and/or gender within the publication. Eleven (20%) studies reported sex or gender imbalance as being a potential reason for outcome differences, with 3 studies conducting an adjusted statistical analysis investigating sex/gender as a moderator. Findings highlight low uptake of sex and gender considerations in the context of mind-body IMIs. Results underscore the need to incorporate guideline-based sex and gender terms and concepts, from data collection and analysis to reporting of evidence to inform mind-body IMI development and guide future research. Stratified sex and/or gender analyses are encouraged in future studies to assess intervention outcome differences.