Emotion Regulation
Emotion Regulation
Abstract Resumo
Objective: An important subject in evaluation of the efficacy of Objetivo: É importante, na avaliação da eficácia de tratamentos,
treatments is to examine how the intervention is effective and examinar como a intervenção tem efeito e identificar suas
to identify the consequences of that treatment. In this regard, consequências. O presente estudo investiga o papel da regulação
the current study investigates the role of emotion regulation as emocional enquanto mediadora de desfechos do tratamento
the mediator of the treatment outcomes of therapy using the que emprega o Protocolo Unificado (PU) para o tratamento
Unified Protocol (UP) for transdiagnostic treatment of emotional transdiagnóstico de transtornos psicológicos.
disorders. Método: Este artigo descreve um ensaio clínico randomizado
Method: This article describes a double-blind randomized duplo-cego. Uma amostra de 26 indivíduos foi selecionada
clinical trial. A sample of 26 individuals was selected based com base em escores pré-estabelecidos para o Inventário de
on cut-off scores for the Beck Depression Inventory and Beck Depressão de Beck e o Inventário de Ansiedade de Beck, e seus
Anxiety Inventory and their final diagnoses were confirmed with diagnósticos finais foram confirmados utilizando o instrumento
the Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV). Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV). A
The sample was randomly divided into two groups: control and amostra foi dividida aleatoriamente em dois grupos: controle e
treatment (13 patients each). The treatment group received 20 tratamento (13 pacientes em cada). O grupo tratamento recebeu
one-hour UP sessions. The Beck Depression Inventory, the Beck 20 sessões de PU de 1 hora cada. O Inventário de Depressão
Anxiety Inventory, and the Difficulties in Emotion Regulation de Beck, Inventário de Ansiedade de Beck Beck e Escala de
Scale were administered at two stages, pre-treatment and post- Dificuldades de Regulação Emocional foram administrados em
treatment. duas etapas, antes e depois do tratamento.
Results: The UP reduced anxiety and depression in patients Resultados: O PU reduziu a ansiedade e a depressão em
through improvement in emotion regulation. Furthermore, the pacientes, ao melhorar a regulação emocional. Além disso,
results showed that the difficulty engaging in goal-directed os resultados mostraram que as subescalas dificuldade de se
behavior and non-acceptance of emotional response subscales engajar em comportamentos orientados por objetivos e não
were capable of predicting 62% of variance in anxiety scores. In aceitação de resposta emocional responderam por 62% da
turn, two subscales, difficulty engaging in goal-directed behavior variância nos escores de ansiedade. Nos escores de depressão,
and lack of emotional clarity, predicted 72% of variance in duas subescalas, dificuldade de se engajar em comportamentos
depression scores. orientados por objetivos e falta de claridade emocional,
Conclusion: Emotion regulation can be considered as a potential explicaram 72% da variância.
mediating factor and as predictive of outcomes of transdiagnostic Conclusão: A regulação emocional pode ser considerada o
treatment based on the UP. principal fator mediador e também preditora de desfechos do
Clinical trial registration: Iranian Registry of Clinical Trials, tratamento transdiagnóstico baseado no PU.
IRCT2017072335245N1. Registro do ensaio clínico: Iranian Registry of Clinical Trials,
Keywords: Emotion regulation, mediator, treatment outcomes, IRCT2017072335245N1.
unified protocol, randomized clinical trial. Descritores: Regulação emocional, mediador, desfechos de
tratamento, protocolo unificado, ensaio clínico randomizado.
1
Department of Clinical Psychology, Faculty of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran. 2 Social Determinant of Health Research Center,
Zanjan University of Medical Sciences, Zanjan, Iran. 3 Department of Psychiatry, Faculty of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.
This article is part of the first author’s master’s thesis, presented at the Zanjan University of Medical Sciences (reference no. A-11-924-2).
Submitted Aug 30 2018, accepted for publication Dec 10 2018.
Suggested citation: Khakpoor S, Saed O, Armani Kian A. Emotion regulation as the mediator of reductions in anxiety and depression in the Unified Protocol
(UP) for transdiagnostic treatment of emotional disorders: double-blind randomized clinical trial. Trends Psychiatry Psychother. 2019;41(3):227-236. http://dx.doi.
org/10.1590/2237-6089-2018-0074
emotional disorders and have shown that treatments Material and methods
could effectively decrease emotion regulation, studies
examining the mediating role of this construct during This study is a double-blind randomized clinical
treatment are rare. To our knowledge only Sauer trial and has been approved by the ethics committee
Zavala et al.22 have investigated the role of negative at Zanjan University of Medical Sciences (reference
affectivity and negative reactivity to emotions in number: ZUMS.REC.1396.143). All patients enrolled
predicting outcomes in UP. Their results suggested agreed to take part in the study and signed a free and
that how people interact with negative emotions informed consent form. The study is also registered
can better predict the treatment outcomes than the on the Iranian Registry of Clinical Trials (registration
frequency of these emotions. It seems that recognizing number: IRCT2017072335245N1).
the mechanism of change as well as identifying
the role of common vulnerabilities such as emotion Participants
regulation, as a mediator of treatment outcomes, The statistical population for this research is all
could be beneficial to developing this treatment. students at the Zanjan University of Medical Science.
Although studies have shown that the UP is effective Figure 1 summarizes the sampling process. First, a
in improving emotion regulation strategies, few sample of 315 people was recruited from the statistical
studies have considered this structure as a mediator population by convenience sampling and then the
of UP outcomes. In this regard, the present study Beck Anxiety Inventory (BAI) and the Beck Depression
seeks to examine the efficacy of the UP, in addition Inventory (BDI) were administered. In the second step,
to investigating the role of emotion regulation as the individuals with depression scores between 20 and 28
mediator of the treatment outcomes. and anxiety scores from 16 to 30 were selected (149
Screening (n=315)
123 Excluded
Refused to participate in the study (n=68)
Not resident in Zanjan city during the trial (n=40)
Had psychiatric diagnosis listed in exclusion criteria (n=9)
Had a history of previous psychological interventions (n=6)
Randomized
Did not complete the treatment (n=1) Did not complete the treatment (n=1)
24 Analyzed
0 Excluded from analysis
people). Finally, a sample of 26 individuals was selected mood, and somatoform disorders and previous mental
from among these people by application of inclusion and health background. This scale also includes a short
exclusion criteria and Cohen table. Inclusion criteria screening for psychotic symptoms and alcohol and
included residence in Zanjan city during the research, substance use. Large-scale evaluations of this tool have
willingness to participate in the research, and having a been carried out and found strong support for using it
principal diagnosis of any anxiety or depressive disorder on the basis of its diagnostic reliability. Each diagnosis
(assessed using the Anxiety Disorders Interview is graded from 0 (no symptoms) to 8 (extremely severe
Schedule for DSM-IV-Lifetime Version [ADIS-IV-L]). symptoms) on a clinical severity rating (CSR) scale. A
Exclusion criteria included having a DSM-IV diagnosis CSR score of 4 is the threshold for diagnosis based on
of bipolar disorder, schizophrenia, or schizoaffective DSM-IV. The schedule has a very good internal reliability
disorder; diagnostic history of psychiatric disorders; for anxiety and mood disorders.23
having a history of previous psychological interventions
(particularly more than 5 sessions of cognitive behavioral Beck Depression Inventory (BDI-II)
therapy); absence from more than two sessions in a This 21-item inventory was designed by Beck et
row; or not participating in the evaluation process. al. in 1996 to measure the severity of depression
Subsequently, these 26 individuals were randomly over the preceding two weeks. Items are scored
assigned to treatment or control groups of 13 patients from 0 to 3 on 4-point Likert scales. Total scores on
each, selected by the second author of this study using the inventory are classified as follows: 10-13, minor
Random Number Generator 3.1 software (the therapist depression; 14-19, mild depression; 20-28, moderate
was blind to randomized condition). All participants depression; and 29-63, severe depression.24 Studies of
signed a written voluntary informed consent form. During the psychometric properties of the BDI-II conducted in
the treatment, 1 member of the treatment group and various countries have shown that the inventory has
1 member of the control group failed to complete the acceptable reliability. Beck et al. reported high internal
treatment. The treatment group (n = 12) comprised consistency for the inventory (α = 0.91) and 1-week
25% males and 75% females (mean age = 17.5, SD = test-retest reliability of 0.93. A study conducted in Iran
4 years) and the control group (n =12) included 16.7% with non-clinical and clinical samples reported internal
males and 83.3% females (mean age = 27.66, SD = 5.23 consistency coefficients of 0.90 and 0.89, respectively,
years). 25% of participants in the treatment group were while the test-retest coefficient for the non-clinical
undergraduate students, 33.3% were graduate students sample was 0.94.25
, and 41.7% were medical students. In the control group,
33.3% of participants were undergraduate students, Beck Anxiety Inventory (BAI)
33.3% were graduate students, and 33.3% were medical The BAI is a 21-item inventory which was designed
students. According to chi-square test (χ2) results, there by Beck et al. in 1998 to measure the severity of
were no significant differences between the two groups anxiety in adults and adolescents. Total scores on the
in terms of gender or education and, according to the inventory are classified as follows: 0-7, minor anxiety;
independent t-test, the two groups did not differ in 8-15, mild anxiety; 16-25, moderate anxiety; and 26-
mean age (p > 0.05), which indicates that the treatment 63, severe anxiety. Beck et al.26 obtained a Cronbach’s
and control groups are homogeneous in demographic alpha coefficient of 0.93 and the 5-week test-retest
variables. Principal diagnoses included: obsessive- reliability coefficient for this inventory is 0.83. Adequate
compulsive disorder (OCD, n = 3), generalized anxiety internal consistency and test-retest reliability have been
disorder (GAD, n = 8), social anxiety disorder (SOC, n reported for this inventory (α = 0.92 and rtt = 0.83).27
= 5), panic disorder (PD, n = 1), and major depressive
disorder (MDD, n = 5). Two participants had co-principal Difficulties in Emotion Regulation Scale (DERS)
diagnoses (of equal severity): SOC with PD, and OCD with The DERS was developed by Gratz & Roemer in 2004,
GAD. Comorbid disorders included MDD (n = 5) and OCD with 36 items and 6 subscales for measuring emotion
(n = 1). None of the participants used psychiatric drugs dysregulation and emotional self-regulation strategies.
during the evaluation or treatment phases. The scale’s subscales include lack of acceptance of
emotional responses; difficulty in performing purposeful
Measures behavior; difficulty controlling impulse; lack of emotional
Anxiety Disorders Interview Schedule for DSM-IV- awareness; limited access to emotion regulation
Lifetime Version (ADIS-IV-L) strategies; and lack of clarity of emotion. The higher
This is a semi-structured diagnostic interview which the score, the lower the emotion regulation ability. This
is designed to assess existence and severity of anxiety, scale has demonstrated high internal consistency (α =
0.93) and adequate 2-week test-retest reliability (rtt = weekly meetings were also organized between the
0.85).28 Cronbach’s alpha coefficients for the reliability therapist and the professor of clinical psychology (the
of the Persian version of this scale vary in the range of second author) to supervise the sessions.
0.79 to 0.91 and its test-retest reliability is from 0.86
to 0.88 after 1 week.29 Data analysis
Descriptive statistics (mean, standard deviation,
Procedure frequency and tables) and inferential statistics were
The treatment group received 20 one-hour used to analyze data. The homogeneity of demographic
individual treatment sessions. The UP was designed variables between treatment and control groups was
in 8 treatment modules (sessions and modules are studied using χ2 test and the independent t-test.
described in Table 1). Diagnostic interviews and patient Hedges’ effect size, which is more appropriate for small
evaluations were conducted by a psychiatrist (the third samples, was calculated to determine the magnitude
author of this article) who was blind to randomized of change from pre-treatment to post-treatment in the
condition. The therapist for this study was a clinical treatment group. The prediction formula for Hedges’
psychology Masters student (the first author of this effect size is stated as follows.
article) who was trained in cognitive behavioral therapy M1 – M
and transdiagnostic treatment. All treatment sessions hedges’g =
SD Pooled
were conducted under the supervision of a professor of
(s12) + (s22)
clinical psychology (the second author of this article). SD Pooled =
2
In order to determine the appropriateness of the UP
sessions, therapeutic sessions were recorded by the One-way analysis of covariance (ANCOVA) was
therapist and were randomly examined by a professor used to compare the treatment and control groups by
of clinical psychology (the second author). Additionally, dependent variables and to examine the role of emotion
Module 2. Psychoeducation 2 In this module, the adaptive nature of the emotions and the main components of
emotional experience were taught to patients.
Module 3. Present-focused, 3-5 During this module, patients were helped to understand how to observe and react
nonjudgmental awareness to their emotions and practice present-focused awareness using mindfulness
exercises.
Module 4. Increasing cognitive 6-8 In this module, patients are asked to identify their common thinking traps, learn
flexibility how to modulate maladaptive thinking patterns, and increase their flexibility in
assessing different situations.
Module 5. Identification and 9-11 This module generally focused on the behavioral components of emotional
prevention of emotional and experience and helped patients to identify emotional avoidance and emotion-
behavioral avoidance driven behaviors (EDBs) and work on current patterns of emotional responses.
Module 6. Increasing the awareness 12-14 During this module, patients were encouraged to increase their tolerance
and tolerance of physical to physical sensations. The therapist performed exercises to stimulate body
sensations sensations similar to those associated with anxiety and discomfort.
Module 7. Situational emotion 15-19 During this module, the therapist helped patients to plan and then confront an
exposures emotional avoidance hierarchy. In these exposures, emphasis is on emotional
experience.
Module 8. Relapse prevention 20 This module includes an overview of the treatment content and patient progress.
The therapist helped patients to identify ways in which treatment advantages
maintain and predict future difficulties.
regulation as a mediator of treatment outcomes, by for covariance analysis were observed, including the
controlling for initial differences between groups in the relative variability of the dependent variables, the
pre-test of dependent variables included as covariates. normal distribution of variables, according to the
Stepwise regression analysis was used to study the Kolmogorov-Smirnov test, in both treatment and
mediating role of the difficulties in emotion regulation control groups (p > 0.05), the equality of covariance
subscales in reducing anxiety and depression. Data variables in both groups, according to Levene’s test
were analyzed using SPSS-20 software. (p > 0.05), conducting pre-test before treatment,
linear correlation between dispersion (pre-test) and
the independent variable (p < 0.01), and homogeneity
Results of regression slopes in both anxiety and depression
variables (p > 0.05).
Table 2 lists means and standard deviations of The ANCOVA results in the first stage showed that
pre-test, post-test, and change scores for anxiety, after controlling for the effect of pre-test results, mean
depression, and difficulty in emotion regulation in the scores for anxiety and depression in the treatment group
treatment and control groups. were significantly reduced compared to the control
Hedges’ effect size was used to investigate the effect group (p < 0.0001), which suggests the efficacy of the
of the UP for reduction of anxiety and depression in the UP for reducing anxiety and depression. Considering
treatment group from pre-test to post-test. Hedges30 the research hypothesis that emotion regulation plays
reported effect sizes of 2.0, 5.0, and 8.0 as small, a mediating role in the efficacy of the UP for reducing
medium, and large, respectively. The results show that anxiety and depression, in the second phase, in addition
the UP produced strong reductions in anxiety (Hedges’ to controlling for the effect of pre-test results, difficulties
g = 1.23) and depression (Hedges’ g = 0.87) in the in emotion regulation change scores were also controlled.
treatment group from pre-test to post-test. These results showed that there was no significant
Table 3 lists the results of ANCOVA, assessing the difference between treatment and control groups after
efficacy of the UP for anxiety and depression, controlling controlling for the effect of emotion regulation (p > 0.05),
for the effects of pre-test anxiety, depression, and the which suggests that emotion does play a mediating role
role of emotional regulation. The main assumptions in this treatment (Table 3).
Multivariate regression analysis was conducted to for predicting change in anxiety. These results indicate
investigate the roles of the subscales of difficulties in that the best predictor of anxiety is difficulty engaging
emotion regulation as mediators of change in anxiety in goal-directed behavior, which alone could explain
and depression (Table 5). First, the change score 53.4% of the anxiety variances. This means that
(change score = pretest - posttest) was calculated for 53.4% of anxiety changes are explained by change in
each of the variables from the anxiety, depression, and the difficulty engaging in goal-directed behavior score.
difficulties in emotion regulation subscales. The main In the second step, the non-acceptance of emotional
assumptions of the regression test, including normality, responses subscale was added to the regression and,
linearity, and homogeneity of variance, were observed, together with the difficulty engaging in goal-directed
according to the standard residual chart method. Table behavior, these two subscales had the power to explain
4 shows the correlation matrix for the variables. 62% of the variance of anxiety.
The results of multivariate regression analysis The second multivariate regression analysis
suggest two models for prediction of anxiety and examined change in difficulties in emotion regulation
depression based on the difficulties in emotion subscales for predicting change in depression. These
regulation subscales. The first analysis examined results indicate that the best predictor of depression
change in difficulties in emotion regulation subscales is the difficulty engaging in goal-directed behavior
Variable 2 3 4 5 6 7 8 9
1. BAI 0.694* 0.726† 0.731† 0.689† 0.167 0.590† 0.514† 0.732†
2. BDI 1 0.519† 0.813† 0.645† 0.284 0.733† 0.539† 0764†
DERS
3. Nonaccept 1 0.813† 0.540† 0.340 0.508† 0.478* 0.765†
4. Goals 1 0.757† 0.299 0.676† 0.638† 0.877†
5. Impulse 1 0.151 0.682† 0.481† 0.676†
6. Awareness 1 0.183 0.563 †
0.522†
7. Strategies 1 0.529† 0.824†
8. Clarity 1 0.793†
9. Total score 1
BAI = Beck Anxiety Inventory; BDI = Beck Depression Inventory; DERS = Difficulties in Emotion Regulation Scale; Nonaccept= Nonacceptance of emotional
responses; Goals = Difficulty engaging in goal-directed behavior; Impulse = Impulse control difficulties; Awareness = Lack of emotional awareness; Strategies
= Limited access to emotion regulation strategies; Clarity = Lack of emotional clarity.
* p < 0.05, † p < 0.01.
Table 5 - Multivariate regression analysis for prediction of change in anxiety and depression
Dependent variable/model/
predictive variable R R2 F p of F Beta t p
BAI
Model 1
Goals 0.731 0.531 24.03 0.0001 0.731 4.9 0.0001
Model 2
Goals 0.433 2.2 0.40
0.787 0.620 16.028 0.0001
Nonaccept 0.418 2.13 0.046
BDI
Model 1
Goals 0.813 0.660 40.8 0.0001 0.813 6.39 0.0001
Model 2
Goals 0.584 3.65 0.002
0.850 0.723 26.04 0.0001
Clarity 0.338 2.11 0.047
BAI = Beck Anxiety Inventory; BDI = Beck Depression Inventory; Nonaccept = Nonacceptance of emotional responses; Goals = Difficulty engaging in goal-
directed behavior; Clarity = Lack of emotional clarity.
subscale, which alone could explain 66% of the improvement in how one reacts to one’s emotions,
depression variance. In the second step, lack of more than reduction of negative emotions, can predict
emotional clarity was added to difficulty engaging in the severity of symptoms after treatment.
goal-directed behavior and together they were able The UP can improve emotion regulation strategies
to predict 72.3% of depression variance. The F test in different ways, thereby reducing the anxiety and
showed that prediction of anxiety and depression depression of people with emotional disorders. People
in both models is significant (p < 0.05). In the first with emotional disorders experience more intense
anxiety prediction model, difficulty engaging in goal- emotion in dealing with environmental stimuli and
directed behavior had a coefficient of β = 0.731 and t interpret their emotional experiences as threats.33
= 4.19 and, in the second model, non-acceptance of Accordingly, the UP, by emphasizing how this group
emotional responses had a coefficient of β = 0.418 and of patients experience and face emotions, teaches
t = 2.13, and both were capable of predicting anxiety them to respond to their emotions in a more adaptive
(p < 0.05). In the first depression prediction model, manner. For example, during the treatment, attempts
difficulty engaging in goal-directed behavior had a are made to improve how individuals react to their
coefficient of β = 0. 813 and a value of t = 6.39 and, in emotions and to modify their assessments of their
the second model, non-acceptance of emotional clarity emotions, using present-focused, non-judgmental
had a coefficient of β = 0.338 and t = 2.11, and both awareness (module 3), cognitive flexibility (module 4),
were capable of predicting depression (p < 0.05). and prevention of emotional and behavioral avoidance
(module 5). Furthermore, during the UP, individuals
have the opportunity to practice the emotion regulation
Discussion strategies learned in previous modules by using
situational emotion exposure (modules 6 and 7). These
The first goal of this study was to examine the encounters help people to increase their tolerance to
efficacy of the UP for improving anxiety and depression emotions and create new situational learning. The key
in people with emotional disorders. The initial results to these encounters is to eliminate the maladaptive
showed that the UP could significantly reduce anxiety emotion regulation strategies (such as emotional
and depression in the treatment group relative to avoidance or maladaptive situation modification) and
the control group. This finding is consistent with the stimulate authentic emotion.
underlying theories and therapeutic goals of the UP. On the other hand, a closer look revealed that
The improvement observed in this study is in line with difficulty engaging in goal-directed behavior can predict
the results of Pearl & Norton,19 Farchion et al.,31 and a large proportion of the change in anxiety (53%) and
Elard et al.30 and provides additional empirical evidence depression (66%) scores. As previously mentioned,
to support the efficacy of the UP in the treatment of the UP makes people face unpleasant emotions and
emotional disorders. situations and prevents them from escaping or avoiding
The second goal of this study was to investigate these experiences. Under such conditions, and in the
the indirect effect of treatment through emotion absence of catastrophic consequences, individuals form
regulation. The results showed that the UP reduces new learnings about their emotions and can pursue more
the anxiety and depression of people with emotional goal-directed behaviors despite their disorders. In fact,
disorders through improvement of their emotion the UP reduces the symptoms of emotional disorders
regulation strategies. The study findings indicate that by increasing goal-directed behavior and improving the
there is a relationship between emotion regulation overall performance of individuals when experiencing
strategies and symptoms of anxiety and depression.32 unpleasant emotions.
Given that the UP seeks to improve the vulnerability Additionally, the results revealed that the subscales
of emotional disorders (and not the specific symptoms lack of emotional response and lack of emotional clarity
and signs of any disorder), emotion regulation can were the second-strongest predictors of change in
be considered as a potential change factor in this anxiety and depression scores, respectively. Maladaptive
protocol. Previous research has reviewed the role attentional deployment (e.g. worry, rumination,
of emotion regulation and indicates that few studies distraction) is one of the maladaptive strategies of
have focused on the mediating role of emotion emotion regulation.6 Evidence suggested that emotion
regulation strategies as the mechanism of change regulation strategies based on mindfulness, as well
during CBT.15 Only a study conducted by Sauer Zavala as recognizing and accepting internal experiences,
et al.22 has studied this structure as the mediator of without attempting to change or avoid them, are good
the outcomes of the UP. Their results showed that alternatives to emotion dysregulation strategies.34 In
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Anxiety. 1997;6:140-6. Department of Clinical Psychology, Faculty of Medicine, Zanjan
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of Beck Anxiety Inventory among the university students. Iran J Zanjan, Iran
Psychiatry Clin Psychol. 2013;7:37-46. Tel.: + 98 24 33534500, Fax: + 98 24 33534500
E-mail: o.saed@zums.ac.ir