Journal of Affective Disorders 303 (2022) 206–215 Contents lists available at ScienceDirect Journal of Affective Disorders journal homepage: www.elsevier.com/locate/jad The mediating role of emotion regulation in transdiagnostic cognitive behavioural therapy for emotional disorders in primary care: Secondary analyses of the PsicAP randomized controlled trial Roger Muñoz-Navarro a, *, Leonardo Adrián Medrano b, Joaquín T. Limonero c, César González- Blanch d, Juan A. Moriana e, Paloma Ruiz-Rodríguez f, Antonio Cano-Vindel g a Department of Personality, Assessment and Psychological Treatments Faculty of Psychology. University of Valencia, Av. Blasco Ibáñez, 10. 46010. Valencia, Spain b Department of Psychology, Pontificia Universidad Católica Madre y Maestra, Autopista Duarte Km 1 1/2, Santiago De Los Caballeros 51000, Dominican Republic c Department of Basic Psychology, University Autonoma of Barcelona, Plaça Cívica, 08193 Bellaterra, Barcelona, Spain d Mental Health Centre, University Hospital “Marqués de Valdecilla”- IDIVAL. Av. Valdecilla, 25, 39008 Santander, Cantabria, Spain e Department of Psychology, University of Córdoba/ Maimónides Institute for Research in Biomedicine of Cordoba-IMIBIC/Reina Sofía University Hospital. Av. Menéndez Pidal, s/n, 14004 Córdoba, Spain f Castilla La Nueva Primary Care Centre, Health Service of Madrid. Calle Teruel, 4, 28941 Fuenlabrada, Madrid, Spain g Department of Experimental Psychology. Faculty of Psychology, Complutense University of Madrid, Campus de Somosaguas, s/n, 28223 Madrid, Spain A R T I C L E I N F O A B S T R A C T Keywords: Background: Emotional disorders are highly prevalent in primary care. Transdiagnostic cognitive behavior Transdiagnostic therapy (TD-CBT) is a promising treatment of emotional disorders. In this study, we evaluated several emotion Cognitive behavioural therapy regulation strategies as potential mediators of treatment outcomes in a clinical sample of primary care. Anxiety Methods: A total of 1061 primary care patients were included in a randomized clinical trial comparing treatment- Depression Somatization as-usual (TAU) to TD-CBT+TAU. Of these, 631 (TAU=316; TD-CBT+TAU=315) completed the full treatment Mediators and all pre- and post-treatment scales to assess symptoms (anxiety, depression, somatization), emotion regulation Emotion regulation strategies (worry, rumination, negative metacognition, suppression, cognitive reappraisal), overall functioning, Randomized clinical trial and quality of life (QoL). Results: Treatment and direct effects showed that TD-CBT+TAU was superior to TAU alone. On the multivariate mediation analysis of indirect effects, three maladaptive strategies (worry, rumination and negative metacog­ nition) had significant effects on all emotional symptoms. Suppression was also significant for depression. Rumination and negative metacognition were significant mediators of functioning, while only negative meta­ cognition was significant for QoL. Reappraisal had no effect on any outcome. Limitations: We focused mainly on maladaptive cognitive emotion regulation strategies and only studied one behavioural strategy (suppression) and one adaptive strategy (reappraisal). Conclusions: Targeting certain maladaptive emotion regulation strategies (worry, rumination, suppression, negative metacognition) as mediators for treatment with TD-CBT could reduce emotional symptoms and improve well-being. Negative metacognition was the most transdiagnostic strategy, whereas an adaptive strategy such as reappraisal was not a mediator. Thus, maladaptive emotion regulation strategies are key mediators in trans­ diagnostic therapy for emotional disorders in primary care. 1. Introduction (Cuijpers et al., 2019b) and anxiety disorders (Seekles et al., 2013), in the primary care setting. This is important given that these are two of the Cognitive behavioural therapy (CBT) has been shown to be an most prevalent and disabling mental health disorders in the population effective treatment for common mental disorders, including depression (Whiteford et al., 2013; 2015). CBT has many benefits. Not only it is * Corresponding author. E-mail addresses: roger.munoz@uv.es (R. Muñoz-Navarro), Leonardo.Medrano@ues21.edu.ar (L.A. Medrano), joaquin.limonero@uab.cat (J.T. Limonero), cesar. gonzalezblanch@scsalud.es (C. González-Blanch), jamoriana@uco.es (J.A. Moriana), pruizr@salud.madrid.org (P. Ruiz-Rodríguez), canovindel@psi.ucm.es (A. Cano-Vindel). https://doi.org/10.1016/j.jad.2022.01.029 Received 24 May 2021; Received in revised form 30 December 2021; Accepted 4 January 2022 Available online 5 January 2022 0165-0327/© 2022 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). R. Muñoz-Navarro et al. Journal of Affective Disorders 303 (2022) 206–215 cost-effective (Chisholm et al., 2016; Layard and Clark, 2015), but it is transdiagnostic framework with different emotional disorders. relatively easy to deliver on a wide scale in public health systems (Clark, The focus of the PsicAP project was to treat emotion regulation 2018). Based on recent data, transdiagnostic therapies represent a strategies that have been shown to play a transdiagnostic role in highly promising approach for the treatment of mental disorders emotional disorders (Aldao et al., 2010; Picó-Pérez et al., 2017; Sun because the same therapy can be used to treat several different disorders et al., 2017). Some of these maladaptive strategies, such as rumination (Cassiello-Robbins et al., 2020), and can be delivered in a group format or worry, are closely associated with anxiety and depression disorders (Cano-Vindel et al., 2021; Roberge et al., 2020), which makes them even (Aldao et al., 2010; Kircanski et al., 2015; McLaughlin and Nolen-­ more cost-effective. Hoeksema, 2011) and with negative metacognition (Sun et al., 2017; Recently, several transdiagnostic perspectives that leveraged two Wells, 2008). Also, an adaptive strategy known as cognitive reappraisal, central aims have generated a great deal of interest (Fusar-Poli et al., which reflects an effort to change the subjective evaluation of an 2019). First, some perspectives are based on studying the similar effects emotion-generating situation to modify its emotional impact (Gross, that certain treatments such as CBT have on different diagnostic groups 2015), may also help to reduce symptoms and improve wellbeing when (Newby et al., 2015; Norton et al., 2013), while others are more focused patients are trained to use this coping strategy (King and dela Rosa, on the study of the common etiological processes shared by these con­ 2019; Picó-Pérez et al., 2017). Expressive suppression is an emotion ditions such as cognitive-affective or behavioural factors (Caspi et al., regulation strategy first described by Gross (2015) that regulates 2014; Kotov et al., 2021). In recent years, there has been a growing behavioural or emotional response after an emotion has been generated. interest in assessing the individual components of CBT, particularly This strategy has been associated with anxiety, although the evidence transdiagnostic CBT (TD-CBT), in order to better identify the specific for its role in depression is mixed (Dryman and Heimberg, 2018). aspects of CBT that are the main drivers of treatment outcomes (Cuijp­ Adaptive and maladaptive emotion regulation strategies appear to use ers et al., 2019a; Holmes et al., 2018). In this line of research, there is a different cognitive and neural pathways (Picó-Pérez et al., 2019). special interest in gaining a better understanding of the role of mediators Clearly, much valuable research has been performed in this area, but and mechanisms of change in psychotherapy (Hofmann and Hayes, we still need to better determine the transdiagnostic strategies that are 2019; Høglend and Hagtvet, 2019). In this context, emotion regulation is most effective in reducing symptoms of anxiety, depression and soma­ a major target of TD-CBT (Sakiris and Berle, 2019; Sloan et al., 2017). tizations. We also need to understand how these strategies reduce This perspective posits that CBT can be used to train patients to improve symptoms and improve measures of wellbeing (e.g., functioning or QoL) certain cognitive and behavioural emotion regulation strategies, which in order to gain insights into which approach works best for a given in turn may help to reduce symptoms (Naragon-Gainey et al., 2017; condition/symptom, and how it works. This would provide a better Picó-Pérez et al., 2017). Sloan et al. (2017) suggested that effectiveness understanding of transdiagnostic treatments. Given this background, we of transdiagnostic treatments may be attributable to a reduction in some performed a secondary analysis of data from the PsicAP RCT using the maladaptive emotion regulation strategies (e.g., rumination, worry, and measures administered after treatment completion to evaluate, in an suppression) while simultaneously increasing other, more adaptive exploratory manner, the mediating effects of emotion regulation stra­ strategies (e.g., reappraisal or distraction). Other transdiagnostic ap­ tegies in primary care patients with emotional disorders who underwent proaches have focused more on reducing comorbidity in individuals TD-CBT+TAU versus TAU alone. with anxiety disorders (Norton et al., 2013; Norton and Barrera, 2012); indeed, such strategies have proven effective when delivered in a group 2. Methods format in the primary care setting (Roberge et al., 2020). The available data suggests that the effectiveness of this treatment approach in 2.1. Participants and procedure reducing anxiety is mainly due to its capacity to target mediators such as negative affect and intolerance to uncertainty (Talkovsky and Norton, The PsicAP study (Cano-Vindel et al., 2021) was an RCT conducted at 2014). Some authors have suggested that metacognition may be a po­ 22 primary care centres within the Spanish National Health System. tential mechanism of change in psychotherapy (Misso et al., 2019), General practitioners (GP) invited adult patients (ages 18 to 65) with a while other researchers have focused on behavioral activation (Dimag­ diagnosis or suspected diagnosis of an emotional disorder to participate gio and Shahar, 2017) or other more positive/adaptive strategies such as in the trial. A total of 1061 participants were included and randomized hope (Gallagher et al., 2020) and cognitive reappraisal (Gross, 2015). to TAU delivered by the recruiting GP (controls) or TD-CBT+TAU Recently, a large (1061 patients) randomized controlled trial (RCT) (experimental arm). Trained clinical psychologists delivered seven conducted in Spain (Cano-Vindel et al., 2021) demonstrated the effec­ group sessions of TD-CBT (groups of 8–10 patients) over a 12–14 week tiveness of TD-CBT for emotional disorders (anxiety, depression, and period to train patients in cognitive and behavioural techniques to help somatization) in the primary care setting. In that trial (the PsicAP study), regulate emotions (see Cano-Vindel et al., 2016 for more details on the participants were randomized to either treatment-as-usual (TAU) or training protocol). The TAU intervention consisted of regular consulta­ group TD-CBT plus TAU. The results showed that TD-CBT plus TAU was tions with the GP. Patients in this group with emotional complaints highly efficacious in reducing symptoms and improving both quality of received TAU, which mainly consisted of the prescription of anxiolytics, life (QoL) and functioning. More than 300 patients were treated in both antidepressants, or hypnotics, and/or informal counselling/support. For groups, with 12-month follow-up data available for nearly 200 in each the present study, we used the per-protocol sample (see Cano-Vindel group. TD-CBT significantly reduced emotional symptoms, with me­ et al., 2021), which consisted of 631 patients in the two groups dium to large effect sizes (d=− 0.65 to − 1.01) at the post-treatment (TAU=316 vs TD-CBT+TAU=315) who completed all pre- and evaluation, and these results were sustained over time. Patients in the post-treatment measures. The study was conducted in accordance with experimental arm also obtained significant improvements in the sec­ the principles of the Declaration of Helsinki and following the Spanish ondary outcome measures, with small to medium effect sizes for func­ Law on Data Protection (EUDRACT: 2013–001,955–11 and Protocol tioning (d=− 0.26 to − 0.51) and several QoL domains (d = 0.31 to 0.61); Code: ISRCTN58437086). moreover, these effect sizes were even greater at the 12-month follow-up assessment (d = 0.29 to 0.73). In addition, large between-group effect 2.2. Instruments sizes (d >0.80) were observed for reliable recovery rates, which were similar to those achieved in the IAPT program in the United Kingdom 2.2.1. Measures of symptoms (Clark, 2018; Wakefield et al., 2020) and Norway (Knapstad and Generalized anxiety disorder-7 (GAD-7): The GAD-7 was used to assess Nordgreen, 2018; Knapstad et al., 2020). The results of the PsicAP trial symptoms of GAD. On this instrument, participants are asked to rate the are particularly notable given that the group therapy was provided in a frequency of anxiety symptoms during the past 2 weeks (total score 207 R. Muñoz-Navarro et al. Journal of Affective Disorders 303 (2022) 206–215 range: 0–21), on a 4-point Likert scale from 0 (not at all) to 3 (nearly every response scale ranging from 1 (almost never) to 4 (almost always). Mean day). We used the validated Spanish version of the GAD-7 scale (Gar­ (SD) scores were 13.6 (3.6). Internal consistency was adequate cía-Campayo et al., 2010), which is also valid for Spanish primary care (α=0.77). patients and has shown excellent psychometric properties (Moreno The Metacognitions Questionnaire–Negative Beliefs (MCQ-NB): The et al., 2019; Muñoz-Navarro et al., 2017a). Mean (standard deviation original MCQ-30 was developed by Wells and Cartwright-Hatton [SD]) scores were 12.3 (4.6) and the internal consistency of the scale (2004). The MCQ-NB is a brief 5-item scale that assesses negative beliefs was good (α=0.87). about uncontrollability/danger. This scale was validated by Patient Health Questionnaire-9 (PHQ-9): The PHQ-9 (Kroenke et al., Muñoz-Navarro et al. (2020) to assess this negative metacognition in 2001) was used to assess symptoms of depression. This scale contains primary care patients. Responses to the items are given on a 4-point nine items based on DSM-IV criteria for major depression evaluated on a Likert-type response scale ranging from 1 (totally disagree) to 4 (totally 4-point Likert scale from 0 (not at all) to 3 (nearly every day), with a total agree). In our study, the mean (SD) score was 16.4 (4.1) and internal score range from 0 to 27. The instrument has good psychometric prop­ consistency was good (α=0.80). erties (sensitivity and specificity), and was validated in a sample of Emotion Regulation Questionnaire (ERQ): The ERQ (Gross & John, participants in the primary care setting in Spain (Muñoz-Navarro et al., 2013) is a 10-item self-report tool, validated in Spanish (Cabello et al., 2017b). The mean (SD) score on the PHQ-9 was 13.6 (5.4). The scale 2013), designed to assess cognitive reappraisal (ERQ-R, 6 items)—an showed a good internal consistency (α=0.86). adaptive emotion regulation strategy—and expressive suppression Patient Health Questionnaire-15 (PHQ-15): The PHQ-15 sum score (ERQ-S, 4 items), a maladaptive strategy. Responses are given on a (maximum score = 30) was used to assess somatic symptoms (Kroenke 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly et al., 2002). We used the Spanish version of the PHQ (Spitzer et al., agree). Both subscales have demonstrated good levels of internal con­ 1999), which asks patients to rate 13 somatic symptoms on a scale from sistency, reliability, and validity across different samples and cultures 0 to 2, as follows: 0 (not bothered), 1 (bothered a little), or 2 (bothered a (Preece et al., 2020). Mean (SD) scores for these two subscales were 25.6 lot). In addition to those 13 items, the scale also includes two items from (7.6) and 15.5 (6.0), respectively. The internal consistency was good for the PHQ-9 (sleep and tiredness), scored as follows: 0 (not at all), 1 the ERQ-R (α=0.80) and adequate for the ERQ-S (α=0.76). (several days), or 2 (more than half the days or nearly every day). The reliability of this scale was acceptable (α=0.80), with a mean (SD) score 2.2.3. Measures of functioning of 14.2 (4.8). Sheehan Disability Scale (SDS): The participants’ overall level of disability was measured with the SDS (Luciano et al., 2010). This in­ 2.2.2. Measures of emotion regulation strategies strument asks patients about the extent to which their symptoms Penn State Worry Questionnaire – Abbreviated (PSWQ-A): The PSWQ interfere with three daily life domains (work, social, and family life). was developed by Meyer et al. (1990) to assess worry. An abbreviated Participants rate the degree of interference on a 10-point Likert scale 8-item version of the PSWQ (PSWQ-A) was developed by Hopko et al. ranging from 0 (not at all) to 10 (extremely). The total score is the sum (2003) for use in older adults. We used the Spanish version of the score of the three items. The mean (SD) score was 12.9 (8.2), with good PSWQ-A previously validated in primary care patients by internal consistency (α=0.80). Muñoz-Navarro et al. (2020), who found that the scale has excellent World Health Organization Quality of life Instrument-Abbreviated psychometric properties. Patients can response on a 5-point Likert scale version (WhoQoL-Bref): To evaluate overall QoL, we used the single ranging from 1 (it is not typical in me) to 5 (it is very typical in me). Mean item on the WhoQoL-Bref designed to assess general QoL (Lucas-Car­ (SD) scores were 30.1 (6.8) and the internal consistency obtained in this rasco, 2012). Patients respond to the question “How would you rate your study was good (α=0.89). quality of life?” on a 5-point Likert scale ranging from 1 (very bad) to 5 Ruminative Responses Scale – Brooding (RRS-B): The RRS was devel­ (very good). The mean (SD) score was 2.9 (0.8). oped by Nolen-Hoeksema & Morrow (1991) and validated in the Spanish population by Hervás-Torres (2008). This scale is designed to 2.3. Statistical analyses assess different types of rumination. The 5-item subscale corresponding to the "brooding" factor (RRS-B) was validated by Muñoz-Navarro et al. Descriptive statistics are provided for pre- and post-treatment (2020) in primary care patients. The RRS-B uses a four-point Likert-type symptoms, emotion regulation strategies, functioning, and QoL based Fig. 1. Hypothetical multiple mediation model of emotion regulation in transdiagnostic cognitive behavioural therapy. Δ represent change scores values from pre- to post-treatment. 208 R. Muñoz-Navarro et al. Journal of Affective Disorders 303 (2022) 206–215 on the per-protocol results reported by Cano-Vindel et al. (2021). We independent variables to the mediators, and/or from the mediators to performed an analysis of variance (ANOVA) to evaluate treatment effi­ the dependent variables. However, if the indirect effects were signifi­ cacy in terms of symptom relief, which were also reported previously in cant, this indicates that the effects on dependent variables were through Cano-Vindel et al. (2021). We also added changes in emotion regulation the mediators. strategies, functioning, and QoL. Within-group effect sizes (pre-­ to-post-treatment) are provided for each group using the Cohen’s effect 3. Results size measure. Between-group effect sizes were determined using the Morris’d effect size measures, which consider the mean and standard 3.1. Treatment efficacy deviation of the sample at the pre- and post-treatment assessments; this technique provides a more representative effect size when the values Descriptive statistics are presented in Table 1. Of the 1061 ran­ differ at baseline (Morris, 2008). The IBM-SPSS statistical software domized patients, 631 (TAU=316 and TD-CBT+TAU=315) completed program, v. 26, was used to perform all statistical analyses. the full treatment and all pre- and post-treatment instruments. The be­ We used the SPSS PROCESS macro, v.3.5 (Hayes, 2018) to test the tween-group’s analyses showed that emotional symptoms had large ef­ mediation effects under bias-corrected 95% confidence intervals (CI) for fect sizes for anxiety and depression, and a medium effect size for the indices using bootstrap calculations based on 10,000 samples. somatization. All of the emotion regulation strategies—except for sup­ Treatment allocation (TAU or TD-CBT+TAU) was included as an inde­ pression (ERQ-S)—were significant, with small to medium between- pendent variable (X) and symptoms (GAD-7, PHQ-9, or PHQ-15), group effect sizes observed for maladaptive emotion regulation and a functioning (SDS) and QoL (WhoQoL-Bref) as dependent variables (Y). positive small effect size for reappraisal. Significant improvements in We sought to determine whether emotion regulation strategies worked functioning (medium effect size) and QoL (small effect size) were as mediators (M) between the treatment allocation (X) and the depen­ observed, especially in the TD-CBT+TAU group (Table 1). Within-group dent variables (Y), and we evaluated both direct and indirect effects (see effect sizes showed a significantly stronger effect in the TD-CBT+TAU Fig. 1 for the hypothetical model). We calculated the change scores (pre- group, with large effect sizes for emotional symptoms and medium effect to post-treatment) on the mediators and outcomes to test indirect effects sizes for worry, rumination, negative metacognition and reappraisal, of treatment allocation (X) on outcome change scores (ΔY) via mediator except for suppression, which was small. In the TAU group, within- change scores (ΔM). To assess the independent association between group effect sizes were small, with no significant effect on reappraisal each of the emotion regulation strategies and the outcome variables, and suppression. mediators were entered simultaneously to control for intercorrelations among variables. Thus, we conducted five different multivariate medi­ ation analyses to test these effects for each outcome. These mediation 3.2. Mediation analysis analyses were conducted using ordinary least squares regression in path-analytic form (Montoya and Hayes, 2017). For direct effects, we When we tested the multivariate mediation analyses, treatment evaluated the multivariate effects of the independent variable to the allocation had significant direct effects on change scores for all of the mediators (ai) and the effect of the mediators on the dependent variables emotion regulation strategies, with larger effects in the TD-CBT+TAU (bi). We also tested the total effect of the treatment condition on the group: reappraisal (β=− 2.597; SE=0.660; t=− 3.935; p = 0.0001); outcome (c), which is the sum of the direct effect (c’ path) and indirect suppression (β=1.443; SE=0.464; t = 2.468; p = 0.014); negative effect (ab paths) such that c = c’ + (ab). Thus, we represented in each metacognition (β=2.394; SE=0.341; t = 7.011; p<0.0001); rumination triangle figure the following paths: a) the a-path from X to M; b) the (β=1.422; SE=0.281; t = 5.058; p<0.0001); and worry (β=3.472; b-path from M to Y; c) the c-path from X to Y; d) and the c’-paths from X SE=0.542; t = 6.405; p<0.0001). Figs. 2 to 6 show the results of the to Y. Beta regression (β) values are presented as standardized β, with mediation models. standard deviation (SD) and with asterisks (*p < 0.05; **p < 0.01, *** p The direct effects of mediators on anxiety were significant for < 0.001) to indicate the significant paths. For indirect effects, we pro­ negative metacognition (β=0.299; SE=0.022; t = 6.382; p<0.0001); vide the point estimate (B values) and both the lower-level (LL) and rumination (β=0.211; SE=0.060; t = 3.486; p<0.0001); and worry upper-level (UL) of the CI, which is considered significant when the (β=0.164; SE=0.031; t = 5.241; p<0.0001), with no significant effects 0 value does not fall within the 95% CI (Hayes, 2018). If direct effects for reappraisal (β=− 0.016; SE=0.223; t=− 0.709; p = 0.479) or sup­ were significant, this indicates that a direct effect was found from the pression (β=0.056; SE=0.033; t = 1.716; p = 0.087). Indirect effects were significant for negative metacognition, rumination, and worry Table 1 Means and between- and within-group effect sizes for outcomes and mediators. Pre-treatment sample Post-treatment sample Within-group Between-group Outcomes Total TAU TD-CBT +TAU TAU TD-CBT +TAU TAU TD-CBT+TAU (n = 1061) (n = 316) (n = 315) (n = 316) (n = 315) p Cohen’s d p Cohen’s d p Morris’ d Symptoms Anxiety (0 – 21) 12.3 (4.6) 12.9 (4.6) 12.6 (4.7) 10.2 (5.5) 6.0 (4.3) <0.001 − 0.53 <0.001 − 1.47 <0.001 − 1.01 Depression (0 – 27) 13.6 (5.4) 13.4 (5.4) 13.8 (5.1) 11.5 (6.6) 7.0 (5.2) <0.001 − 0.32 <0.001 − 1.32 <0.001 − 0.92 Somatizations (0 – 30) 14.2 (4.8) 14.0 (4.6) 14.1 (4.9) 12.1 (5.2) 9.1 (5.3) <0.001 − 0.39 <0.001 − 0.98 <0.001 − 0.65 Emotion Regulation Strategies Reappraisal (6 – 42) 25.6 (7.6) 24.6 (7.0) 25.8 (7.3) 25.0 (8.4) 28.7 (7.6) 0.42 0.05 <0.001 0.39 <0.001 0.37 Suppression (4 – 28) 15.5 (6.0) 15.3 (6.0) 15.5 (6.0) 15.0 (6.4) 14.0 (6.0) 0.33 − 0.05 <0.001 − 0.25 0.05 − 0.19 Metacognition (6 – 24) 16.4 (4.1) 16.1 (4.1) 16.5 (4.1) 15.5 (4.6) 13.3 (4.1) 0.003 − 0.14 <0.001 − 0.78 <0.001 − 0.59 Rumination (5 – 20) 13.6 (3.6) 13.3 (3.5) 13.5 (3.6) 12.8 (3.9) 11.6 (3.6) 0.018 − 0.14 <0.001 − 0.53 <0.001 − 0.40 Worry (8 – 40) 30.1 (6.8) 29.9 (6.5) 29.7 (7.1) 28.6 (7.2) 24.9 (6.8) <0.001 − 0.19 <0.001 − 0.69 <0.001 − 0.51 Functioning Total (0 – 30) 12.9 (8.2) 12.4 (7.5) 13.2 (7.5) 11.3 (8.2) 8.2 (7.5) 0.022 − 0.14 <0.001 − 0.67 <0.001 − 0.52 Quality of Life General (0 – 5) 2.9 (0.8) 2.9 (0.8) 2.9 (0.8) 3.0 (0.8) 3.2 (0.8) 0.024 0.13 <0.001 0.38 <0.001 0.25 Abbreviations: TAU, treatment-as-usual; TD-CBT, transdiagnostic cognitive-behavioural therapy;. 209 R. Muñoz-Navarro et al. Journal of Affective Disorders 303 (2022) 206–215 Fig. 2. Multiple mediation model on anxiety symptoms. Note: *p < 0.05, **p < 0.01, *** p < 0.001. Δ represent change scores values from pre- to post-treatment. (Fig. 2 and Table 2). were significant for suppression, negative metacognition, rumination The direct effects of mediators on depression were significant for and worry (Fig. 3 and Table 2). suppression (β=0.133; SE=0.039; t = 3.427; p<0.001); negative meta­ For somatization, direct effects of mediators were significant for cognition (β=0.333; SE=0.056; t = 5.969; p<0.0001); rumination negative metacognition (β=0.167; SE=0.046; t = 3.615; p<0.0001), (β=0.205; SE=0.072; t = 2.853; p<0.001); and worry (β=0.120; rumination (β=0.164; SE=0.059; t = 2.773; p<0.001), and worry SE=0.037; t = 3.224; p<0.001), with no significant effects for reap­ (β=0.066; SE=0.031; t = 2.146; p<0.05), with no significant effects for praisal (β=− 0.016; SE=0.027; t=− 0.605; p = 0.545). Indirect effects reappraisal (β=0.005; SE=0.022; t = 0.224; p = 0.823) or suppression (β=0.030; SE=0.032; t = 0.927; p = 0.354). Indirect effects were sig­ nificant for negative metacognition, rumination and worry (Fig. 3 and Table 2 Table 2). Estimates of indirect effects of the multivariate mediation analyses . The direct effects of mediators on functioning were significant for Results of multivariate indirect effects negative metacognition (β=0.379; SE=0.081; t = 4.668; p<0.0001) and 95% CI rumination (β=0.491; SE=0.104; t = 4.713; p<0.0001) with no signif­ icant effects for reappraisal (β=− 0.026; SE=0.039; t=− 0.674; p = Dependent Mediator Point estimate (SE) LL UL variable 0.501), suppression (β=0.040; SE=0.056; t = 0.697; p = 0.486), or worry (β=0.085; SE=0.054; t = 1.577; p = 0.115). Indirect effects were GAD-7 Reappraisal − 0.016 (0.023) − 0.060 0.028 significant for negative metacognition and rumination (Fig. 3 and Suppression 0.056 (0.037) − 0.008 0.119 Table 2). Metacognition 0.299 (0.047) 0.207 0.392 For QoL, direct effects of mediators were significant only for negative Rumination 0.210 (0.060) 0.091 0.329 metacognition (β=− 0.037; SE=0.081; t = 4.533; p<0.0001), with no Worry 0.163 (0.031) 0.102 0.225 PHQ-9 significant effects for reappraisal (β=0.001; SE=0.039; t=− 0.295; p = Reappraisal − 0.016 (0.026) − 0.069 0.036 0.769), suppression (β=− 0.002; SE=0.056; t=− 0.300; p = 0.764), Suppression 0.132 (0.038) 0.056 0.208 rumination (β=− 0.011; SE=0.011; t=− 1.021; p = 0.308), or worry Metacognition 0.333 (0.055) 0.223 0.442 (β=− 0.008; SE=0.054; t=− 1.417; p = 0.157). Indirect effects were only Rumination 0.204 (0.071) 0.063 0.345 significant for negative metacognition (Fig. 3 and Table 2). Worry 0.119 (0.037) 0.046 0.192 PHQ-15 Reappraisal 0.005 (0.022) − 0.038 0.048 4. Discussion Suppression 0.029 (0.031) − 0.033 0.092 Metacognition 0.166 (0.046) 0.076 0.256 Rumination 0.164 (0.059) 0.047 0.280 Transdiagnostic treatments are a highly promising approach for Worry 0.065 (0.030) 0.005 0.125 emotional disorders such as depression and anxiety (Cassiello-Robbins Functioning et al., 2020), with the available data suggesting that the treatment has Reappraisal − 0.026 (0.039) − 0.102 0.050 effects, at least partially, through certain mediators such as emotion Suppression 0.039 (0.056) − 0.071 0.149 regulation strategies (Sakiris and Berle, 2019; Sloan et al., 2017). In the Metacognition 0.378 (0.081) 0.219 0.537 Rumination 0.491 (0.104) 0.286 0.695 present study, we evaluated data from a large RCT to determine the Worry 0.085 (0.053) − 0.020 0.190 mediating role of emotion regulation strategies (according to treatment QoL-Gen allocation) on symptoms of anxiety, depression and somatization, as Reappraisal 0.001 (0.003) − 0.006 0.008 well as on functioning and QoL (Cano-Vindel et al., 2021). We found Suppression 0.002 (0.005) − 0.012 0.009 significant indirect effects for most of the maladaptive emotion regula­ − Metacognition − 0.036 (0.008) ¡0.052 ¡0.020 Rumination − 0.010 (0.010) − 0.031 0.009 tion strategies (negative metacognition, rumination and worry) on the Worry − 0.007 (0.005) − 0.018 0.003 three emotional symptoms as well as for suppression in depression, with Note: PHQ-9: patient health questionnaire-9; PHQ-15: patient health better results in all cases in the TD-CBT+TAU group. For functioning, questionnaire-15; Generalized anxiety disorder-7; SDS: Sheehan disability scale: significant indirect effects were observed for negative metacognition QoL-Gen: quality of life - general; WQL-Gen: WHOQOL-Bref-General item; LL: and rumination; by contrast, the only mediator of QoL was negative lower limit; UL: upper limit. The indirect effect is statistically significant (in bold metacognition. Cognitive reappraisal was never significant. This implies formating) if the confidence interval (CI) does not include zero. that the greatest improvement in emotional symptoms, functioning and 210 R. Muñoz-Navarro et al. Journal of Affective Disorders 303 (2022) 206–215 Fig. 3. Multiple mediation model on depression symptoms. Note: *p < 0.05, **p < 0.01, *** p < 0.001. represent change scores values from pre- to post-treatment. Fig. 4. Multiple mediation model on somatic symptoms. Note: *p < 0.05, **p < 0.01, *** p < 0.001. represent change scores values from pre- to post-treatment. Fig. 5. Multiple mediation model on functioning. Note: *p < 0.05, **p < 0.01, *** p < 0.001. represent change scores values from pre- to post-treatment. 211 R. Muñoz-Navarro et al. Journal of Affective Disorders 303 (2022) 206–215 Fig. 6. Multiple mediation model on quality of life. Note: *p < 0.05, **p < 0.01, *** p < 0.001. represent change scores values from pre- to post-treatment. QoL was achieved by targeting these mechanisms of change through rumination, worry, or negative metacognition through psychotherapy TD-CBT+TAU, especially with the three maladaptive emotion regula­ (Aldao and Nolen-Hoeksema, 2010; Hsu et al., 2015; Kircanski et al., tion strategies. Finally, negative metacognition could be considered the 2015; Muñoz-Navarro et al., 2020). Finally, the improvement in func­ most transdiagnostic emotion regulation strategy, not only for tioning and QoL was significant but with small effect sizes, as expected emotional symptoms, but also for functioning and QoL. (Cano-Vindel et al., 2021). When we evaluated the within-group effect Interestingly, the transdiagnostic group therapy tested in this study sizes, we found large effect sizes for emotional symptoms in the may represent an efficient approach to providing evidence-based psy­ TD-CBT+TAU group, but medium effect sizes for anxiety and small ef­ chological therapy for people suffering from anxiety, depression, and fect sizes for depression and somatization in the TAU group. An somatization, all of which commonly present with high comorbidity important finding in the TAU group was that neither cognitive reap­ (Cassiello-Robbins et al., 2020; Sakiris and Berle, 2019). The large praisal nor suppression were significant and the effect sizes were very sample evaluated in this RCT makes these findings quite robust, small for the three maladaptive strategies. By contrast, in the trans­ providing valuable insights into the mediating role of emotion regula­ diagnostic group, these effect sizes were large for negative metacogni­ tion as the core aspect of transdiagnostic therapy and revealing the tion, small for suppression and medium for the rest, and the effects were processes and mechanisms of psychotherapy underlying the changes significant on all analyses. These effects could explain why trans­ (Hofmann and Hayes, 2019). In this regard, the treatment of maladap­ diagnostic therapy could be more efficacious than TAU with regard to tive emotion regulation strategies, especially cognitive strategies outcomes, as there may be a learning effect, with potential mediators of (worry, rumination and negative metacognition), but also a behavioural treatment outcomes. strategy like suppression, can yield positive results. By contrast, reap­ Analysis of direct effects showed that treatment allocation had a praisal (an adaptive strategy) did not reduce symptoms nor improve significant effect on all strategies, with large standardized beta val­ wellbeing, suggesting that it may not be a good transdiagnostic target. ues—particularly for worry, rumination, and negative meta­ However, this finding contradicts previous research showing that tar­ cognition—and with slightly smaller values for reappraisal and very geting adaptive strategies could help to prevent anxiety and depression small values for suppression. These findings were expected and in (Arango et al., 2018; Moreno-Peral et al., 2020). Accordingly, helping accordance with previous studies (Sakiris and Berle, 2019; Sloan et al., primary care patients to manage emotions by providing them with 2017). These direct effects on dependent variables such as anxiety, cognitive and behavioural resources through psychoeducational and depression, and somatization presented significant and positive effects psychological interventions may greatly reduce the enormous burden of in three maladaptive emotion regulation strategies (negative metacog­ these disorders (Megías-Robles et al., 2019; Moreno-Peral et al., 2020). nition, rumination and worry). In this case, suppression had an indirect As Cano-Vindel et al. reported (2021), TD-CBT significantly reduced effect only for depressive symptoms while reappraisal had no effect at symptoms of anxiety, depression, and somatization, with a large effect any emotional symptoms. For functioning, two maladaptive strategies size for anxiety and depression, and a medium effect size for somatiza­ (negative metacognition and rumination) had a significant effect but tion. In the present work, significant reductions (medium effect sizes) in only negative metacognition were significant for QoL. Finally, reap­ these symptoms were found for all of the maladaptive emotion regula­ praisal was not significant for any outcomes, which was an unexpected tion strategies studied except for suppression, which had no significant finding given that previous studies have reported an association be­ effect. The adaptive cognitive reappraisal strategy also had a significant tween these adaptive strategies and both anxiety and depression (Hsu positive effect, although the effect size was small. These results are et al., 2015; Picó-Pérez et al., 2017), which has also been found to be consistent with previous reports on the effects of transdiagnostic treat­ more closely associated with improved wellbeing than reduction of ments on emotion regulation strategies (Sakiris and Berle, 2019; Sloan distress and unpleasant feelings (King and dela Rosa, 2019). et al., 2017), which found medium effect sizes for maladaptive strategies Finally, indirect effects were evaluated using multivariate mediation and small effect sizes for adaptive strategies. These findings are also in analyses, which showed that three maladaptive emotion regulation line with other studies, which have found that the treatment of mal­ strategies (worry, negative metacognition, and rumination) could be adaptive emotion regulation strategies is efficacious for reducing com­ considered mediators for treatment of emotional symptoms. Suppres­ mon psychopathologies such as anxiety and depression (Aldao et al., sion had an indirect effect only for depressive symptoms. For QoL, only 2010; Sakiris and Berle, 2019). Thus, transdiagnostic treatments appear negative metacognition was a significant mediator. For functioning, the to have a more positive impact on emotion regulation than TAU, only significant mediators were rumination and negative metacognition. underscoring the importance of targeting maladaptive strategies such as Again, reappraisal was not significant for any outcome, which was 212 R. Muñoz-Navarro et al. Journal of Affective Disorders 303 (2022) 206–215 unexpected given the findings reported by other authors. In this regard, and behavioural. This analysis provides powerful insights into the Enrique et al. (2021) conducted a similar study to ours as a secondary treatment of emotional disorders in primary care, which is the first point analysis of an RCT in which participants received internet-based CBT. In of contact for all patients with mental health problems and where most that study, mediation analyses of emotion regulation on depression and are treated. anxiety symptoms showed that reappraisal was the only significant mediator, but not suppression nor worry, findings that differ from our 5. Conclusions data. These results could be explained by the fact that we performed the multivariate mediation analyses by introducing the mediating variables The results of this study show that certain maladaptive emotion simultaneously, which allowed us to study the intercorrelations within regulation strategies—worry, rumination-brooding type, and negative the mediators, thus leaving out the strategies with less variance on in­ metacognition—may be potential targets for transdiagnostic therapy direct effects. Given these findings, we can deduce that worry, due to their mediating role in the treatment of emotional disorders. rumination-brooding type, and negative metacognition such as negative Suppression may also be a mediator for depression. Negative metacog­ beliefs about uncontrollability and danger are clear candidates to be nition could be considered the most transdiagnostic strategy. Our data considered transdiagnostic mediators for the treatment of emotional suggest that reappraisal is not a significant mediator. The findings pre­ disorders (Aldao and Nolen-Hoeksema, 2010; Hsu et al., 2015; Kircan­ sented in this work suggest that emotion regulation strategies should be ski et al., 2015; Muñoz-Navarro et al., 2020). Moreover, negative considered mediators of transdiagnostic therapy delivered in primary metacognition was the most transdiagnostic strategy, which supports care for the treatment of emotional disorders. the effect of metacognitive therapy for emotional disorders, functioning and well-being (Sun et al., 2017; Wells, 2008). Thus, even though sup­ Funding sources pression and reappraisal were not transdiagnostic, these strategies may be worth targeting based on previous evidence indicating a positive role This work has been supported by the Fundación Española para la for these strategies in anxiety and depression (Enrique et al., 2021). As ́ Promoción y el Desarrollo Cientifico y Profesional de la Psicologiá to we showed in a study published recently (Muñoz-Navarro et al., 2020), Antonio Cano-Vindel; by the Agencia Estatal de Investigación even though these strategies are theoretically unidimensional, they may (PSI2012–36,589) to Antonio Cano-Vindel and (SI2014–56,368-R) to be highly correlated. In this regard, future studies could seek to deter­ Juan A. Moriana; and by the IDIVAL (INNVAL 16/08 and PRIMVAL 18/ mine if there is a latent factor within these emotion regulation strategies 03) to César González-Blanch. that could explain the transdiagnostic effect of psychological therapy using transdiagnostic processes such as emotion regulation training. CRediT authorship contribution statement This study has several strengths and limitations. First, we focused mainly on cognitive emotion regulation strategies and only studied one Roger Muñoz-Navarro: Conceptualization, Methodology, Formal behavioural strategy (suppression). It would be interesting in the future analysis, Writing – original draft, Project administration. Leonardo to evaluate additional strategies such as behavioural avoidance, Adrián Medrano: Validation, Methodology, Visualization, Writing – distraction, intolerance to uncertainty and/or other strategies that play a review & editing. Joaquín T. Limonero: Validation, Writing – review & role in anxiety and depression (Naragon-Gainey et al., 2017). In addi­ editing. César González-Blanch: Validation, Writing – review & edit­ tion, negative metacognition could be not considered properly as an ing, Funding acquisition. Juan A. Moriana: Writing – review & editing, emotion regulation strategy. However, it is worth emphasizing that the Supervision, Funding acquisition. Paloma Ruiz-Rodríguez: Data strategies that we studied in the present work had been validated in a curation, Writing – review & editing. Antonio Cano-Vindel: Project previous study (Muñoz-Navarro et al., 2020), which demonstrated that administration, Supervision, Writing – review & editing, Funding brief scales can detect the presence of these emotion regulation strate­ acquisition. gies, which is important in the primary care setting. Another limitation is that we only evaluated one adaptive strategy (reappraisal), which had Declaration of Competing Interest no effect on any outcomes. Future studies should assess other adaptive cognitive and behavioural emotion regulation strategies, which could The authors declare no conflict of interest provide a deeper understanding of the role of adaptive strategies in constructs related to wellbeing (e.g., functioning and QoL). Future lines Acknowledgments for research should assess the mediating role of these strategies on other functioning domains, particularly QoL. It would also be necessary to We thank all member of the PsicAP Research Group who participated study this effect over time (e.g., from 6 to 12 months after treatment) to in this large project. help understand the substantial improvement in QoL observed over the long term in a previous study (Cano-Vindel et al., 2021). Also, the use of References change scores in the mediators and outcome variables has some limi­ tations. First, they do not adequately control for baseline imbalances Aldao, A., Nolen-Hoeksema, S., 2010. Specificity of cognitive emotion regulation between groups (Vickers and Altman, 2001). This is because participants strategies: a transdiagnostic examination. Behav. Res. Ther. 48, 974–983. https:// with low scores at the beginning of the study tend to improve more than doi.org/10.1016/j.brat.2010.06.002. 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