Abstract
Psychological interventions for delusions may be enhanced by targeting their presumed causal factors. An emotion-oriented variant of cognitive behavioral therapy for delusions (CBTd-E), designed to target affect regulation and maladaptive schemata, was evaluated for its effect on delusions. A single-blind, multicenter, randomized, waitlist-controlled trial was conducted in three German outpatient clinics. Ninety-four patients with psychotic disorders and persistent delusions were randomized to 25 individual sessions of CBTd-E over 6 months (n = 47) or waitlist (n = 47). CBTd-E included two modules designed to improve affect regulation and maladaptive schemata. Assessments were performed at baseline (T1), three months (T2), and six months (T3). Regression-based analysis of covariance at T3 in the intent-to-treat sample indicated no significant benefit for the CBT-E group in the primary outcome (Psychotic Symptom Rating Scale delusions subscale, d = -0.45 [CI: 0.36; -1.26]). Regarding secondary outcomes, a significant effect favoring CBTd-E was observed in general psychopathology (d = -0.56), but no effects on positive and negative symptoms, depression, general and social functioning, or antipsychotic dosage. Regarding the proposed target mechanisms, we found improved cognitive reappraisal (d = 0.59), worrying (d = -0.52), quality of sleep (d = -0.49), and self-esteem (d = 0.36). Despite its effect on the suggested target mechanisms, affect regulation and maladaptive schemata, and on general psychopathology, this emotion-focused variant of CBT did not show an effect on delusions. A possible avenue to achieve stronger effects on delusions is to personalize the modularized interventions.
Trial registration: Clinicaltrials.gov Identifier: NCT02787135
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Data from the study and all study materials will be available from the corresponding author after a reasonable request.
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Code for the data analysis of the study will be available from the corresponding author after a reasonable request.
References
Bighelli, I. et al. Psychological interventions to reduce positive symptoms in schizophrenia: systematic review and network meta-analysis. World Psychiatry 17, 316–329 (2018).
Turner, D. T. et al. Efficacy and moderators of cognitive behavioural therapy for psychosis vs. other psychological interventions: an individual-participant data meta-analysis. Front. Psychiatry https://doi.org/10.3389/fpsyt.2020/00402 (2020).
Bighelli, I. et al. Psychosocial and psychological interventions for relapse prevention in schizophrenia: a systematic review and network meta-analysis. Lancet Psychiatry 8, 969–980 (2021).
Turner, D. T., Burger, S., Smit, F., Valmaggia, L. R. & Van der Gaag, M. What constitutes sufficient evidence for case-formulation-driven CBT for psychosis? Cumulative meta-analysis of the effect on hallucinations and delusions. Schizophr. Bull. 46, 1072–1085 (2020).
Mehl, S., Werner, D. & Lincoln, T. M. Does cognitive behavior therapy for psychosis (CBTp) show a sustainable effect on delusions? A meta-analysis. Front. Psychol. 6, 1450–1459 (2015).
Kendler, K. S. & Campbell, J. Interventionist causal models in psychiatry: repositioning the mind-body problem. Psychol. Med. 39, 881–887 (2009).
Freeman, D. et al. An early Phase II randomised controlled trial testing the effect on persecutory delusions of using CBT to reduce negative cognitions about the self: the potential benefits of enhancing self confidence. Schizophr. Res 160, 186–192 (2014).
Freeman, D. et al. Effects of cognitive behaviour therapy for worry on persecutory delusions in patients with psychosis (WIT): a parallel, single-blind, randomised controlled trial with a mediation analysis. Lancet Psychiatry 2, 305–313 (2015).
Freeman, D. et al. Efficacy of cognitive behavioural therapy for sleep improvement in patients with persistent delusions and hallucinations (BEST): a prospective, assessor-blind, randomised controlled pilot trial. s. Lancet Psychiatry 2, 975–983 (2015).
Foster, C., Startup, H., Potts, L. & Freeman, D. A randomised controlled trial of a worry intervention for individuals with persistent persecutory delusions. J. Behav. Ther. Exp. Psychiatry 41, 45–51 (2010).
NICE. Psychosis and Schizophrenia in Adults: Treatment and Management [CG 178] (National Institute for Health and Clinical Excellence, 2019).
Myin-Germeys, I. & van Os, J. Stress-reactivity in psychosis: evidence for an affective pathway to psychosis. Clin. Psychol. Rev. 27, 409–424 (2007).
Garety, P., Kuipers, E., Fowler, D., Freeman, D. & Bebbington, P. A cognitive model of the positive symptoms of psychosis. Psychol. Med 31, 189–195 (2001).
Freeman, D. & Garety, P. Advances in understanding and treating persecutory delusions: a review. Soc. Psychiatry Psychiatr. Epidemiol. 49, 1179–1189 (2014).
Freeman, D. Suspicious minds: the psychology of persecutory delusions. Clin. Psychol. Rev. 27, 425–457 (2007).
Waller, H. et al. Thinking Well: A randomised controlled feasibility study of a new CBT therapy targeting reasoning biases in people with distressing persecutory delusional beliefs. J. Behav. Ther. Exp. Psychiatry 48, 82–89 (2015).
Garety, P. et al. Effects of SlowMo, a blended digital therapy targeting reasoning on paranoia among people with psychosis. JAMA Psychiatry 78, 714–725 (2021).
Moritz, S. & Woodward, T. S. Metacognitive training in schizophrenia: from basic research to knowledge translation and intervention. Curr. Opin. Psychiatry 20, 619–625 (2007).
Penney, D. et al. Effectiveness, Durability, and Moderators of Metacognitive Training for Psychosis (MCT): A Systematic Review and Meta-Analysis. JAMA Psychiatry 79, 417–429 (2022).
Moritz, S., Berna, F., Jaeger, S., Westermann, S. & Nagel, M. The customer is always right? Subjective target symptoms and treatment preferences in patients with psychosis. Eur. Arch. Psychiatry Clin. Neurosci. 267, 335–339 (2017).
Freeman, D., Taylor, K. M., Molodynski, A. & Waite, F. Treatable clinical intervention targets for patients with schizophrenia. Schizophr. Res. 211, 44–50 (2019).
Garety, P. & Freeman, D. The past and future of delusion research: from the inexplicable to the treatable. Br. J. Psychiatry 203, 327–333 (2013).
Nowak, U. et al. Are paranoid ideation and hallucination spectrum experiences differently associated with affect dynamics? A continuous-time modeling approach. Emotion 23, 1294–1305 (2023).
Nittel, C. et al. Emotional instability and expressive suppression are related to paranoia in daily life: an experience sampling study in healthy individuals. J. Exp. Psychopathol. https://doi.org/10.1177/2043808719868119 (2019).
Ludwig, L., Mehl, S., Krkovic, K. & Lincoln, T. M. Effectiveness of emotion regulation in daily life in patients with psychosis and non-clinical controls - an experience sampling study. J. Abnorm. Psychol. https://doi.org/10.1037/abn0000505 (2020).
Lüdtke, T., Kriston, L., Schröder, J., Lincoln, T. M. & Moritz, S. Negative affect and a fluctuating jumping to conclusions bias predict subsequent paranoia in daily life: an online experience sampling study. J. Behav. Ther. Exp. Psychiatry 56, 106–112 (2017).
Ludwig, L., Mehl, S., Schlier, B., Krkovic, K. & Lincoln, T. M. Awareness and rumination moderate the affective pathway to paranoia in daily life. Schizophr. Res. 216, 161–167 (2020).
Krkovic, K., Clamor, A., Schlier, B. & LIncoln, T. M. Emotions and persecutory ideation in daily life: on the trail of the “chicken and egg“ problem. J. Abnorm. Psychol. 192, 215–223 (2020).
Schlier, B., Krkovic, K., Clamor, A. & Lincoln, T. M. Autonomic arousal during psychosis spectrum experiences: results from a high resolution ambulatory assessment study over the course of symptom on- and offset. Schizophr. Res. 212, 163–170 (2019).
Ludwig, L., Werner, D. & Lincoln, T. M. The relevance of cognitive emotion regulation to psychotic symptoms - a systematic review and meta-analysis. Clin. Psychol. Rev. https://doi.org/10.1016/j.cpr.2019.101746 (2019).
Bahlinger, K., Lincoln, T. M. & Clamor, A. Are acute increases and variability in emotion regulation strategies related to negative affect and paranoid thoughts in daily life?. Cogn. Ther. Res. 46, 62–72 (2022).
Reeve, S., Sheaves, B. & Freeman, D. The role of sleep dysfunction in the occurrence of delusions and hallucinations: a systematic review. Clin. Psychol. Rev. 42, 96–115 (2015).
Hennig, T. & Lincoln, T. M. Sleeping paranoia away? An Actigraphy and Experience Sampling Study with adolescents. Child Psychiatry Hum. Dev. 49, 63–72 (2018).
Rehman, A., Gumley, A. & Biello, S. Sleep quality and paranoia: The role of alexithymia, negative emotions and perceptual anomalies. Psychiatry Res. 259, 216–222 (2018).
Kammerer, M., Mehl, S., Ludwig, L. & Lincoln, T. M. Sleep and circadian misalignment predict paranoid symptom severity in psychotic patients: a combined actigraphy and experience sampling study. J. Abnorm. Psychol. 130, 78–88 (2020).
Gross, J. J. Handbook of Emotion Regulation (Guilford Press, 2007).
Thewissen, V. et al. Emotions, self-esteem, and paranoid episodes: an experience sampling study. Br. J. Clin. Psychol. 50, 178–195 (2011).
Thewissen, V., Bentall, R. P., Lecomte, T., van Os, J. & Myin-Germeys, I. Fluctuations in self-esteem and paranoia in the context of daily life. J. Abnorm. Psychol. 117, 143–153 (2008).
Kesting, M. L., Bredenpohl, M., Klenke, J., Westermann, S. & Lincoln, T. M. The impact of social stress on self-esteem and paranoid ideation. J. Behav. Ther. Exp. Psychiatry 44, 122–128 (2013).
Jaya, E. S., Ascone, L. & Lincoln, T. M. A longitudinal mediation analysis of the effect of negative-self schemas on positive symptoms via negative affect. Psychol. Med. 28, 1–11 (2017).
Daemen, M. & van Amelsvoort, T. Group Investigators, Reininghaus U. Self-esteem and psychosis in daily life: an experience sampling study. J. Psychopathol. Clin. Sci. 131, 182–197 (2022).
Kesting, M. L. & Lincoln, T. M. The relevance of self-esteem and self-schemas to persecutory delusions: a systematic review. Compr. Psychiatry 54, 766–789 (2013).
Murphy, P., Bentall, R., Freeman, D., O’Rourke, S. & Hutton, P. The paranoia as defence model of persecutory delusions: a systematic review and meta-analysis. Lancet Psychiatry 5, 913–929 (2018).
Barrowclough, C. et al. Self-Esteem in Schizophrenia: relationships Between Self-Evaluation, Family Attitudes, and Symptomatology. J. Abnorm. Psychol. 112, 92–99 (2003).
Lincoln, T. M., Mehl, S., Exner, C. & Rief, W. Attributional style and persecutory delusions. Evidence for an event independent and state specific external-personal attribution bias for social situations. Cogn. Ther. Res. 41, 187–197 (2010).
Moritz, S. et al. Course and determinants of self-esteem in people diagnosed with schizophrenia during psychiatric treatment. Psychosis 2, 144–153 (2010).
Mehl, S. et al. Feasibility and efficacy estimate of an emotion-focused version of cognitive behavior therapy for patients with delusions (CBT-E) in comparison to wait list in a single-blinded randomized-controlled pilot trial. Schizophr. Bull. Open www.kbv.de/media/sp/PraxisWissen_Soziotherapie.pdf (2021).
König, D. Die Regulation von negativen und positiven Emotionen. Entwicklung des Emotionsregulations-Inventars und Vergleich von Migränikerinnen mit Kontrollpersonen (University of Vienna, 2011).
Fowler, D. et al. The Brief Core Schema Scales (BCSS): psychometric properties and associations with paranoia and grandiosity in non-clinical and psychosis samples. Psychol. Med. 36, 749–759 (2006).
Freeman, D. et al. Comparison of a theoretically driven cognitive therapy (the Feeling Safe Programme) with befriending for the treatment of persisting persecutory delusions: a parallel single-blind randomised controlled trial. Lancet Psychiatry 8, 696–707 (2021).
Jones, C., Hacker, D., Cormac, I., Meaden, A. & Irving, C. B. Cognitive behavioural therapy versus other psychosocial treatments for schizophrenia. Cochrane Database Syst. Rev. https://doi.org/10.1002/14651858.CD008712.pub2 (2014).
Hall, P. L. & Tarrier, N. The cognitive-behavioural treatment of low self-esteem in psychotic patients: a pilot study. Behav. Res. Ther. 41, 317–332 (2003).
Lecomte, T. et al. Efficacy of a self-esteem module in the empowerment of individuals with chronic schizophrenia. J. Nerv. Ment. Dis. 187, 406–413 (1999).
Leendertse, J. C. P. et al. Personal recovery in people with a psychotic disorder: a systematic review and meta-analysis of associated factors. Front. Psychiatry 12, 2021 (2021).
Phalen, P., Kimhy, D., Jobes, D. & Bennett, M. Emotional distress and dysregulation as treatment targets to reduce suicide in psychosis: a scoping review. Eur. Arch. Psychiatry Clin. Neurosci. 274, 955–961 (2024).
Enders, C. K. in Handbook of Structural Equation Modeling (ed. Hoyle, H. R.) 223–248 (Guilford Press, 2023).
Enders, C. K. Missing data: an update on the state of the art. Psychol. Methods https://doi.org/10.1037/met0000563 (2023).
Jolley, S. et al. A pilot evaluation of therapist training in cognitive therapy for psychosis: therapy quality and clinical outcomes. Behav. Cogn. Psychother. 43, 478–489 (2015).
Opoka, S. M., Ludwig, L., Mehl, S. & Lincoln, T. M. An Experimental study on the effectiveness of emotion regulation in patients with acute delusions. Schizophr. Res. 228, 206–217 (2021).
Haddock, G., McCarron, J., Tarrier, N. & Faragher, E. B. Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychol. Med 29, 879–889 (1999).
First, M. B., Williams, J. B. W., Karg, R. S. & Spitzer, R. L. Structured Clinical Interview for DSM-5 Disorders - Clinician Version (American Psychiatric Association, 2016).
Kay, S. R., Fiszbein, A. & Opler, L. A. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr. Bull. 13, 261–276 (1987).
Kay, S. R., Opler, L. A. & Fiszbein, A. Positive and Negative Syndrome Scale (PANSS) (Multi Health Systems Inc., 1992).
Hayes, S. C., Strosahl, K. D. & Wilson, K. G. Acceptance and Commitment Therapy: An Experiential Approach to Behavior Change 1st edn (Guilford Press, 1999).
Greenberg, L. S. & Klosterziel, R. Emotionsfokussierte Therapie 1st edn (Reinhard Verlag, 2016).
Hautzinger, M. Kognitive Verhaltenstherapie bei Depression (Beltz, 2021).
Spiegelhalder, K., Backhaus, J. & Riemann, D. Schlafstörungen (Fortschritte der Psychotherapie) (Hogrefe, 2011).
Schweiger, U., Wells, A., Schweiger, J. & Korn, O. Metakognitive Therapie bei Angst und Depression 1st edn (Beltz 2011).
Gilbert, P. Compassion-Focused Therapy: Distinctive Features (Routledge Chapman & Hall, 2010).
Chadwick, P. Person-Based Cognitive Therapy for Distressing Psychosis (Wiley, 2006).
Peters, E. R., Joseph, S., Day, S. & Garety, P. Measuring delusional ideation: the 21-item Peters et al. delusions inventory (PDI). Schizophr. Bull. 30, 1005–1022 (2004).
Geck, S. et al. COSMIN systematic review and meta-analysis of the measurement properties of the positive and negative syndrome scale (PANSS). EClinicalMedicine 82, 103155 (2025).
Mueller, M. J. et al. The Calgary depression rating scale for schizophrenia: development and interrater reliability of a German version (CDSS-G). J. Psychiatr. Res. 10, 799–812 (1999).
Goodman, S. H., Sewell, D. R., Cooley, E. L. & Leavitt, N. Assessing levels of adaptive functioning: the role functioning scale. Community Ment. Health J 29, 119–131 (1993).
Benkert, O. & Hippius, H. Kompendium der Psychiatrischen Pharmakotherapie 14th edn (Springer Verlag, 2023).
Abler, B. & Kessler, H. Emotion regulation questionnaire - Eine deutschsprachige Fassung des ERQ von Gross und John. Diagnostica 55, 144–152 (2009).
Berking, M. & Znoj, H. Development and validation of a questionnaire for standardised self-evaluation of emotion regulation skills (ERSQ). Z. Psychiatr. Psychol. Psychother. 56, 141–153 (2008).
Glöckner-Rist, A. & Rist, F. in Das Wissen um die Messung: Zusammenstellung sozialwissenschaftlicher Items und Skalen (eds Danner, D. & Glöckner-Rist, A) (GESIS, 2014).
Bastien, C. H., Vallières, A. & Morin, C. M. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep. Med. 2, 297–307 (2001).
Gerber, M. et al. Validation of the German version of the insomnia severity index in adolescents, young adults and adult workers: results from three cross-sectional studies. BMC Psychiatry https://doi.org/10.1186/s12888-016-0876-8 (2016).
von Collani, G. & Herzberg, P. Eine revidierte Fassung der deutschsprachigen Skala um Selbstwertgefuehl von Rosenberg. Z. fuer Diffentielle und Diagnostische Psychologie 24, 3–7 (2003).
Hupfeld, J. & Ruffieux, N. Validierung einer deutschen Version der Self-Compassion Scale (SDS-D). Z. Klin. Psychol Psychother 40, 115–123 (2011).
Haddock, G. et al. An inverstigation into the psychometric properties of the cognitive therapy scale for psychosis (CTS-PSY). Behav. Cogn. Psychother. 29, 221–233 (2001).
Borm, G. F., Fransen, J. & Lemmens, W. A. J. G. A simple sample size formula for analysis of covariance in randomized clinical trials. J. Clin. Epidemiol. 60, 1234–1238 (2007).
Faul, F., Erdfelder, E., Buchner, A. & Lang, A. G. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav. Res. Methods 41, 1149–1160 (2009).
Rosseel, Y. lavaan: an R package for structural equation modeling. J. Stat. Softw. 48, 1–36 (2012).
Twisk, J. et al. Different ways to estimate treatment effects in randomised controlled trials. Contemp. Clin. Trials Commun. 10, 80–85 (2018).
Feingold, A. Effect sizes for growth-modeling analysis for controlled clinical trials in the same metric as for classical analysis. Psychol. Methods 14, 43–53 (2009).
Feingold, A. Confidence interval estimation for standardized effect sizes in multilevel and latent growth modeling. J. Consult. Clin. Psychol. 83, 157–168 (2015).
Stekhoven, D. J. & Buehlmann, P. MissForest—non-parametric missing value imputation for mixed-type data. Bioinformatics 28, 112–118 (2012).
Acknowledgements
We thank all participants and the outpatient and inpatient clinic staff who helped support our study: especially we thank Julian Bartke, Sarah Böwer, Nora Deventer, Lisa Dietrich, Meike Engel, Inga Frantz, Nathalie Fritsch, Judith Gonschor, Philipp Herzog, Alexandra Hinkel, Valeska Hug, Franziska Jeromin, Stefanie Krey, Philipp Krug, Nico Leppin, Sandra Lorek, Anne Maenz, Amelie Mattern, Anja Müller, Sandra Päpper, Lea Rebstock, Judith Reichhardt, Paula Siegmann, Hannah Schmucker, Julia Schulz, Julia Sölch, Nele Struck, Asieh Tamari, Janina Thür, Karén Wilhelm, Julia Wittkowski and Yin Zhou. We thank the scientific assistants and blinded raters Nina Bauer, Sophia Belz, Björn Buedenbender, Thilo Friehs, Jasmin Kiener, Johanna Nüsken, Hedda Matzerath, Joachim Rduch, Simon Samstag, Sandra Opoka, and Daniela Zanfino. Finally, we thank Alexandra Kleiman for randomizing the patients. This work was supported by an award from the German Research Foundation (DFG: ME 4490/1-1/ LI 1298-8-1). The funder had no role in the study design, conduct, data collection and analysis, manuscript preparation, and reporting.
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S.M. and T.M.L. conceived the study, planned the trial’s design, interpreted the data, wrote the manuscript, and are the chief investigators; C.H. performed statistical analyses and data interpretation and contributed to writing and revising the manuscript; B. S. contributed to writing, data interpretation, and revising the manuscript; L.D., L.L., and T.T. organized the trial and contributed to writing, data interpretation, and revising the manuscript; W.R., M.F., and R.S. contributed to data interpretation, writing, and revising the manuscript. All authors read and approved the final manuscript.
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The authors declare they have competing interests; S.M., T.L., L.D., L.L., and T.T. provide training and/or supervision in CBTp/CBTd-E. All other authors have no competing interests to report.
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Supplement Efficacy of an emotion-oriented Cognitive Behavior Therapy for delusions (CBTd-E) compared to waitlist in a single-blinded randomized controlled trial
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Mehl, S., Hautmann, C., Schlier, B. et al. Efficacy of an emotion-oriented cognitive behavior therapy for delusions (CBTd-E) compared to waitlist in a single-blinded randomized-controlled trial. Schizophr (2026). https://doi.org/10.1038/s41537-026-00737-y
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DOI: https://doi.org/10.1038/s41537-026-00737-y
