Evidence map›Paper›PMID 41991263›Full record

ArticleBMJ open2026

Negative effects of mindfulness-based cognitive therapy and cognitive behavioural analysis system of psychotherapy for patients with 'difficult to treat' depression: protocol for a systematic review and individual participant data meta-analysis.

Maria Niemi, Johannes Michalak, Maria Velana, Thorsten Barnhofer, Mathias Harrer

Abstract read
In one paragraph

Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

5 authors.

Maria NiemiDepartment of Global Public Health, Karolinska Institutet, Stockholm, Sweden maria.niemi@ki.se.ORCID http://orcid.org/0000-0001-5407-6981
Johannes MichalakDepartment of Psychology and Psychotherapy, Witten/Herdecke University, Witten, Germany.
Maria VelanaDepartment of Psychology and Psychotherapy, Witten/Herdecke University, Witten, Germany.
Thorsten BarnhoferUniversity of Surrey, Guildford, UK.
Mathias HarrerDepartment of Clinical, Neuro- and Developmental Psychology, WHO Collaborating Centre for Research and Dissemination of Psychological Interventions, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMindfulness-based interventions are widely used, yet concerns about potential negative effects-particularly those related to mindfulness meditation practice-have gained increasing attention. Individuals with difficult-to-treat depression (DTD) represent a population of particular relevance due to heightened vulnerability, but comparative evidence on clinically relevant negative outcomes of mindfulness-based cognitive therapy (MBCT) versus established alternative psychotherapies in this group is lacking. This protocol describes a systematic review and individual participant data (IPD) network meta-analysis to assess and compare the incidence of clinically relevant negative outcomes associated with MBCT and the cognitive behavioural analysis system of psychotherapy (CBASP), an established individual psychotherapy for DTD. METHODS AND ANALYSIS: Randomised controlled trials of MBCT and CBASP for adults with DTD were identified through systematic searches of major databases. Eligible studies must compare MBCT or CBASP (alone or with treatment as usual) to each other or to control groups. The primary outcome is clinically significant deterioration, defined as a ≥6-point increase on the Patient Health Questionnaire-9 or equivalent. Secondary outcomes are suicidality and treatment dropout. IPD will be requested from trial investigators; aggregate data will be used when IPD is unavailable. One-stage random-effects IPD network meta-analyses will be conducted to integrate direct and indirect evidence and to examine participant-level moderators of deterioration. Adverse events reported in the included trials will be summarised descriptively at the study level. ETHICS AND DISSEMINATION: No local ethical review was required following consultation with the Swedish Ethical Review Authority. Primary trial investigators obtained local ethical approval and will share pseudonymised IPD. Findings will inform clinical decision-making and guideline development by strengthening the evidence base on potential negative effects of MBCT and CBASP in adults with DTD, including identification of subgroups at increased risk. Results will be disseminated through peer-reviewed publication and accessible summaries for relevant stakeholders. PROSPERO REGISTRATION NUMBER: CRD42022332039.

Indexed as

Cognitive Behavioral TherapyDepressionDepressive DisorderMindfulnessHumansMeta-Analysis as TopicNetwork Meta-Analysis as TopicRandomized Controlled Trials as TopicResearch DesignSystematic Reviews as TopicAdverse eventsDepression & mood disordersMeta-AnalysisMindfulness

Identifiers

PMID41991263
PMCPMC13110557

What OpenQuestion holds

Textmetadata
LicenceCC BY
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 OpenQuestion graph.