Evidence map›Paper›PMID 40221143›Full record

SynthesisBMJ mental health2025

Methodological quality in randomised clinical trials of mental health apps: systematic review and longitudinal analysis.

Jake Linardon, Qiang Xie, Caroline Swords, John Torous, Shufang Sun, Simon B Goldberg

Abstract readSystematic ReviewMeta-Analysis
In one paragraph

Synthesis in BMJ mental health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Jake LinardonSEED Lifespan Strategic Research Centre, School of Psychology, Faculty of Health, Deakin University, Geelong, Victoria, Australia jake.linardon@deakin.edu.au sbgoldberg@wisc.edu.ORCID 0000-0003-4475-7139
Qiang Xie *Department of Counselling Psychology, University of Wisconsin-Madison, Madison, Wisconsin, USA.ORCID 0000-0003-3968-9629
Caroline Swords *Department of Counselling Psychology, University of Wisconsin-Madison, Madison, Wisconsin, USA.ORCID 0009-0005-6373-4997
John TorousBeth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.ORCID 0000-0002-5362-7937
Shufang SunDepartment of Behavioral and Social Sciences, School of Public Health, Brown University, Providence, Rhode Island, USA.ORCID 0000-0001-5215-128X
Simon B GoldbergDepartment of Counselling Psychology, University of Wisconsin-Madison, Madison, Wisconsin, USA jake.linardon@deakin.edu.au sbgoldberg@wisc.edu.ORCID 0000-0002-6888-0126

Funding

TRAINING PROGRAM IN EMOTION RESEARCHT32MH018931 · NIMH · UNIVERSITY OF WISCONSIN-MADISON · PI Richard J Davidson · 1989 to 2026
$11.6M
Advancing Resources for Systematic Reviews and Meta-Analyses of Complementary and Integrative Health InterventionsR24AT012845 · NCCIH · BROWN UNIVERSITY · PI Simon B Goldberg, Eric Loucks · 2024 to 2026
$1.8M
Developing Internet-Delivered, Mindfulness-based Intervention to Reduce HIV Risk and Promote Mental and Sexual Health among Young Adult MSMK23AT011173 · NCCIH · BROWN UNIVERSITY · PI SUN, SHUFANG · 2020 to 2024
$1.0M
Mindfulness training delivered via mobile health to reduce depression and anxietyK23AT010879 · NCCIH · UNIVERSITY OF WISCONSIN-MADISON · PI GOLDBERG, SIMON B · 2020 to 2024
$786k
NCCIH NIH HHS K23 AT010879NCCIH NIH HHS K23 AT011173NCCIH NIH HHS R24 AT012845NIMH NIH HHS T32 MH018931
6 · The paper itself

Abstract

questionThis study investigated the methodological rigour of randomised controlled trials (RCTs) of mental health apps for depression and anxiety, and whether quality has improved over time. STUDY SELECTION AND ANALYSIS: RCTs were drawn from the most recent meta-analysis of mental health apps for depression and anxiety symptoms. 20 indicators of study quality were coded, encompassing risk of bias, participant diversity, study design features and app accessibility measures. Regression models tested associations between year of publication and each quality indicator.

findings176 RCTs conducted between 2011 and 2023 were included. Methodological concerns were common for several quality indicators (eg, <20% were replication trials, <35% of trials reported adverse events). Regression models revealed only three significant changes over time: an increase in preregistration (OR=1.27; 95% CI 1.10, 1.46) and reporting of adverse events (OR=1.32; 95% CI 1.11, 1.56), and a decrease in apps reported to be compatible with iOS and/or Android (OR=0.78; 95% CI 0.64, 0.96). Results were unchanged when excluding outliers. Results were similar when excluding three high-quality studies published between 2011 and 2013, with additional evidence for an increase in modern missing data methods (OR=1.22; 95% CI 1.04, 1.42) and studies reporting intention-to-treat analysis (OR=1.20; 95% CI 1.03, 1.39).

conclusionsFindings provide minimal evidence of improvements in the quality of clinical trials of mental health apps, highlighting the need for higher methodological standards in future research to ensure the reliability and generalisability of evidence for these digital tools.

Indexed as

AnxietyDepressionMobile ApplicationsRandomized Controlled Trials as TopicResearch DesignHumansLongitudinal StudiesAnxiety disordersDepressionPSYCHIATRY

Identifiers

PMID40221143
PMCPMC11997814

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.