Abstract
Barlow et al. published the unified protocol (UP) for transdiagnostic treatment of emotional disorders, focusing on common pathological factors across a variety of diagnoses. The limited UP research to date suggests that this treatment may be particularly useful for anxiety disorders. However, it has largely been evaluated only in individual treatment format. The current study examined the effectiveness of the UP treatment in a group format, with individuals with comorbid anxiety disorder symptoms. Twenty-six individuals with clinically significant anxiety symptoms in at least two of the following areas, social anxiety, worry, or panic, participated in a 14-week manualized group treatment using the UP. Significant decreases were found on general anxiety, worry, social anxiety, panic, depression, and negative affect, and increases on positive affect. The UP may hold promise for a transdiagnostic group treatment of comorbid anxiety symptoms, but further examination of this treatment is warranted.
Introduction
Research from multiple areas points to common, higher order factors that underlie numerous emotional disorders (see Ellard, Fairholme, Boisseau, Farchione, & Barlow, 2010, for review). Barlow, Farchione, et al. (2011) published the unified protocol (UP) for transdiagnostic treatment of emotional disorders, which focuses on common pathological factors across a variety of diagnoses, particularly depression and anxiety disorders. The application of the UP is particularly relevant for anxiety disorders, as emerging literature on constructs such as intolerance of uncertainty, distress tolerance, negative affect, and anxiety sensitivity (AS) suggests that there are several transdiagnostic factors of relevance across various anxiety disorder diagnoses (e.g., Laposa, Collimore, Hawley, & Rector, 2015; Mahoney & McEvoy, 2012). Cognitive-behavioral therapy (CBT) for anxiety disorders is typically delivered in a disorder-specific fashion, and CBT has been shown to be highly effective in the treatment of all of the anxiety disorders (e.g., Norton & Price, 2007). In contrast, the UP is not disorder-specific and focuses instead on common underlying themes, such as negative affect.
The UP is a comprehensive treatment, including interoceptive and situationally based emotion exposures, identifying and modifying maladaptive cognitions, preventing emotional avoidance and increasing emotional awareness, and identifying and modifying emotion-driven behaviors. The UP emphasizes the adaptive, functional nature of emotions; helps facilitate greater tolerance of emotions; increases cognitive flexibility through cognitive reappraisal; and helps identify and correct maladaptive attempts to regulate emotional experiences (Barlow, Farchione, et al., 2011; Farchione et al., 2012). The initial evaluations of the UP included two pilot studies with individuals with depressive and/or anxiety disorders (n = 18, n = 15), of 15 to 18 sixty-minute individual sessions. These studies found significant decreases in depression, anxiety, negative affect, and overall anxiety severity ratings (Ellard et al., 2010). Farchione et al. (2012) conducted a randomized controlled trial of the UP in which 37 participants with a primary anxiety disorder received individual treatment for up to 18 sessions. Some participants, but not all, had comorbid depressive and/or anxiety disorders. The researchers found significant improvement in clinical severity, general symptoms of depression and anxiety, and positive and negative affect. Furthermore, improvement was also seen on self-report measures of worry, panic, and social anxiety for individuals with primary diagnoses of generalized anxiety disorder (GAD), panic disorder with agoraphobia, and social anxiety disorder (SAD), respectively. Bullis, Fortune, Farchione, and Barlow (2014) reported that treatment gains with the UP seen at the 6-month follow-up were largely maintained a year later.
The aforementioned research evaluated the UP in the context of delivery in an individual treatment format. Three studies to date have examined the UP in group format, with adults. De Ornelas Maia, Braga, Nunes, Nardi, and Silva (2013) examined 16 individuals with unipolar depression, some of whom had a variety of comorbid anxiety disorders, and improvement was seen in symptoms of depression and anxiety. De Ornelas Maia, Nardi, and Cardoso (2015) conducted three 12-session groups of eight individuals diagnosed with unipolar depression and/or low to moderate severity anxiety disorders, and found significant improvement on depression and general anxiety symptoms. Bullis et al. (2015) reported on a sample of 11 clients who received the UP in 12 sessions of group format (two groups of five and six participants, respectively). Ten of the 11 participants had a principal diagnosis of an anxiety disorder (the other being dysthymia), and several had additional comorbid diagnoses. They found a large effect size for general anxiety symptoms, and the effect size for depressive symptoms was approximately half of that for anxiety (although still moderate in size). None of the above group-based studies also measured symptoms specific to certain anxiety disorders. In addition, with the exception of the two studies by de Ornelas Maia and colleagues, all of the remaining studies were conducted by the Barlow research group. Replication of these results by independent research groups is warranted.
Furthermore, work is needed to evaluate the UP in a group format, as well as its effects on both general and disorder-specific anxiety symptoms. This is of particular importance in hospital-based settings, given the high demand for psychological treatment, the limited staffing resources, and high comorbidity of anxiety disorders. Given that different anxiety disorders frequently co-occur (Brown, Di Nardo, Lehman, & Campbell, 2001), a treatment that can parsimoniously target different disorders concurrently may lead to cost containment, increased efficiencies, and time savings, for both the patient and therapist. However, Ellard et al. (2010) reported that the achievement of āresponder statusā was somewhat lower in patients with comorbid disorders (64% vs. 73%), and further work is needed to determine the effects of the UP with individuals presenting with more than one area of anxiety difficulty.
The current study aimed to examine the effectiveness of the UP in a group format, with individuals who had comorbid anxiety disorder symptoms. It addresses the following questions: Is the UP, delivered in a group format, effective in (a) decreasing general and disorder-specific anxiety symptoms, (b) decreasing depression symptoms, and (c) decreasing negative and increasing positive affect? We hypothesized that the UP would be effective in decreasing both general and anxiety disorder-specific symptoms, depressive symptoms, and negative affect.
Method
Participants
Participants included treatment-seeking individuals with clinically significant anxiety symptoms in at least two of the following areas, SAD, GAD, or panic disorder with or without agoraphobia (PD/A), who completed the treatment. These three disorders were selected as they represent the main anxiety conditions seen in our hospital clinic. The determination of clinically significant anxiety symptoms was made based on psychiatric consultations completed at a large university-affiliated depressive and anxiety adult outpatient clinic, as well as self-report symptom measures. Each client saw a staff psychiatrist; the psychiatrist administered an unstructured clinical interview with each participant, and diagnosed clinically significant comorbid anxiety symptoms, resulting in the client being referred to the UP group. An additional inclusion criterion was that participants scored at or above the clinical cutoff on at least two of the self-report measures used for assessing severity of panic, worry, and social anxiety symptoms. Clients with acute mania, psychotic symptoms, or current active suicidality were excluded.
Forty-one participants meeting the inclusion/exclusion criteria started the study, and 15 (37%) did not complete it. The 26 participants who completed the study are included in the analyses reported below. Non-completers were not significantly different from completers on severity level of pre-treatment anxiety, F(1, 40) = 0.11, p > .05; panic, F(1, 40) = 0, p > .05; social anxiety, F(1, 40) = 1.36, p > .05; worry, F(1, 40) = 0.91, p > .05; positive affect, F(1, 39) = 0, p > .05; negative affect, F(1, 39) = 0.99, p > .05, or depression symptoms, F(1, 40) = 1.21, p > .05; age, F(1, 37) = 0.38, p > .05; gender, Ļ2(1) = 0.01, p > .05; ethnicity, Ļ2(3) = 7.04, p > .05; or marital status, Ļ2(4) = 4.01, p > .05. Reasons for dropping out of the UP group included medical surgery (two participants), too busy with work/school (two), more intensive treatment was necessary (two), loss in the family (one), not interested in doing homework exercises (one), and unknown (seven). Participants did not receive compensation or payment for engaging in the study.
Participants were primarily female (62%), single (54%), Caucasian (92%), and had an average age of 34.46 years (SD = 11.01). Depression symptoms in this sample were on average in the moderate range. Seventy-seven percent of participants met the clinical cutoff for panic, 100% for worry, and 81% for social anxiety. Seventy-seven percent met the clinical cutoffs for both panic and worry, 58% for both panic and social anxiety, and 81% for both social anxiety and worry. Fifty-eight percent met the clinical cutoffs for all three areas.
Measures
Participants were asked to complete the questionnaires listed below before they started treatment, and at the end of treatment.
Depression Anxiety Stress Scale 21 (DASS)
The DASS is a 21-item measure that has well-established psychometric properties (P. F. Lovibond & Lovibond, 1995; S. H. Lovibond & Lovibond, 1995). It has three subscales: Depression, Stress, and Anxiety. Only the Anxiety subscale was used in this study, and internal consistency in the present sample was good, α = .80.
Social Interaction Anxiety Scale (SIAS)
The SIAS (Mattick & Clarke, 1998) is a 20-item measure that assesses social anxiety with respect to interacting with others. Its reliability and validity are well established (Heimberg, Mueller, Holt, Hope, & Liebowitz, 1992; Mattick & Clarke, 1998). Internal consistency in the present sample was very good, α = .94.
Penn State Worry Questionnaire (PSWQ)
The PSWQ (Meyer, Miller, Metzger, & Borkovec, 1990) is a 16-item self-report measure that assesses severity of worry. It has demonstrated good psychometric properties (Brown, Antony, & Barlow, 1992; Meyer et al., 1990). Internal consistency in the present sample was good, α = .75.
Panic Disorder Severity ScaleāSelf Report (PDSS-SR)
The PDSS-SR (Shear et al., 1997) is a seven-item measure that assesses frequency of panic, anxiety regarding future attacks, interoceptive and situational avoidance, and interference and associated distress. It has shown acceptable reliability and validity (Houck, Spiegel, Shear, & Rucci, 2002; Wuyek, Antony, & McCabe, 2011). Internal consistency in the present sample was good, α = .84.
Quick Inventory of Depressive SymptomsāSelf-Report (QIDS-SR)
The QIDS-SR (Rush et al., 2003) is a 16-item measure of depression severity. It has demonstrated good psychometric properties, and correlates highly with the Hamilton Rating Scale for Depression (Reilly, MacGillivray, Reid, & Cameron, 2015; Rush et al., 2006).
Positive and Negative Affect Scale (PANAS)
The PANAS (Watson, Clark, & Tellegen, 1988) is a 20-item measure of affect, with two subscales: Positive Affect (α = .89) and Negative Affect (α = .83). Ten descriptors are used for each subscale to define their meanings. It has demonstrated good reliability and validity (Watson et al., 1988).
Treatment Manual
Treatment followed the UP therapist manual (Barlow, Farchione, et al., 2011), and included Motivation Enhancement for Treatment Engagement (Module 1), Psychoeducation and Tracking of Emotional Experiences (Module 2), Emotion Awareness Training (Module 3), Cognitive Appraisal and Reappraisal (Module 4), Emotion Avoidance and Emotion Driven Behaviors (Module 5), Awareness and Tolerance of Physical Sensations (Module 6), Interoceptive and Situation-Based Emotion Exposures (Module 7), and Relapse Prevention (Module 8). The research was conducted in a tertiary care hospital that services patients who in general have complex, comorbid difficulties, that are treatment resistant. As a result, we chose to spend two sessions on Module 1, which covers motivation enhancement and goal setting. Given pilot program evaluation work in our clinic that suggested more exposure work within the UP could be beneficial for clients with significant mixed anxiety symptoms, two further aspects of the UP manualized treatment were altered: (a) exposure exercises were moved to an earlier session in the protocol (i.e., starting at Session 5), and (b) imaginal exposure was also included. For exposures to come earlier in the treatment, for this study, the order of the modules was 1, 2, 6, 7, 3, 4, 5, and 8. Table 1 reports the number of weeks spent on each module.
Unified Protocol Modules Covered in Each Week of the Group Treatment.
Exposures were conducted in session and were assigned for homework. Given the variety of anxiety concerns of participants, each group member did not do the same exposures, and instead, exposures were tailored to the participantsā idiosyncratic anxiety concerns. The majority of exposures completed were in vivo, although this could differ across participants, depending on the nature of their anxiety concerns. Homework was reviewed during the first half of the group session, each week. At the end of each session, therapists collaboratively assigned homework for the upcoming week. All participants were instructed to do the same volume and types of homework exercises, although the specific exposures assigned were unique to each participant, based on their specific anxiety concerns. Homework assignments after Week 8 included exposure exercises, in addition to exercises assigned for that weekās module. Group leaders continued to monitor participantsā progress with their exposures throughout the duration of the treatment.
Procedure
Treatment occurred at the depressive and anxiety disorders clinic of a large university-affiliated tertiary care hospital. Participants were offered 14 sessions of group treatment. Clients used the client workbook for the UP (Barlow, Ellard, et al., 2011). Groups typically consisted of eight to 10 participants. Sessions were held weekly for 2 hours, and were co-led by either two clinicians (psychologist, psychometrist, social worker [SW], or occupational therapist [OT]), or a clinician and a PhD level graduate student.
Therapists read the UP therapist manual, and watched the UP clinical demonstrations DVD (Barlow, Farchione, Boisseau, & Ellard, 2011). The psychologist had over a decade of CBT experience, the psychometrist had 8 years, the SW had 1 year, and the OT had 5 years of CBT experience. All but the psychometrist were registered with the college of their discipline, and the psychometrist was supervised by a registered psychologist. Graduate students were supervised by the psychologist, and supervision meetings were held weekly. The psychologist and psychometrist had each previously run at least one UP group before this study started, and the SW and OT co-led the UP group for the first time as part of this study. When co-leading the study, the SW and OT staff were paired with the psychometrist, who had the most UP experience. Regular consultation meetings between group co-leaders occurred throughout the study.
Results
Four missing entries on questionnaire items (three from the pre-PANAS, one from the post-PANAS) were substituted with the mean item response for that item on the questionnaire (cf. Tabachnick & Fidell, 2007). One participant missed several items on the pre-treatment PANAS. Mean item substitution was not possible here due to the volume of missing data, thus on the PANAS pre-treatment measure, N = 25. There were no outliers on the dependent variables. Means and standard deviations for study variables can be found in Table 2.
Means and Standard Deviations for Study Variables.
Note. DASS-A = Depression Anxiety Stress Scale, Anxiety subscale; SIAS = Social Interaction Anxiety Scale; PSWQ = Penn State Worry Questionnaire; PDSSR = Panic Disorder Severity Scale; QIDS = Quick Inventory of Depressive Symptoms; PANAS-pos = Positive and Negative Affect Scale, Positive subscale; PANAS-neg = Positive and Negative Affect Scale, Negative subscale.
To examine changes over treatment, repeated measures ANOVAs were completed on pre-treatment and end of treatment questionnaires. There were significant decreases in symptoms on the DASS-A, F(1, 25) = 64.02, p < .001; SIAS, F(1, 25) = 4.67, p < .05; PSWQ, F(1, 25) = 22.53, p < .001; PDSSR, F(1, 25) = 62.36, p < .001; PANAS-negative, F(1, 24) = 26.34, p < .001; PANAS-positive, F(1, 24) = 12.36, p < .01; and QIDS, F(1, 25) = 10.69, p < .01, scales. Cohenās d effect sizes on the outcome measures (pre-treatment to end of treatment) can be seen in Table 3.
Cohenās d Effect Sizes.
Note. DASS-A = Depression Anxiety Stress Scale, Anxiety subscale; SIAS = Social Interaction Anxiety Scale; PSWQ = Penn State Worry Questionnaire; PDSSR = Panic Disorder Severity Scale; QIDS = Quick Inventory of Depressive Symptoms; PANAS-pos = Positive and Negative Affect Scale, Positive subscale; PANAS-neg = Positive and Negative Affect Scale, Negative subscale.
Participantsā scores on the DASS-A moved from the very severe range at pre-treatment to the moderate range at the end of treatment. Scores on the PSWQ and SIAS remained above their clinical cutoffs at post treatment. Scores on the PDSSR moved from above the clinical cutoff at pre-treatment to below the clinical cutoff at the end of treatment. Participantsā scores on the QIDS remained in the moderate range at the end of treatment. With respect to the PANAS, both pre and post treatment scores on positive affect were lower than the community mean. At pre-treatment, the negative affect mean of the PANAS was just over double that of the community mean, and remained well over the community mean at post treatment (Crawford & Henry, 2004).
Discussion
This study aimed to address the UP in a group format for individuals with comorbid anxiety symptoms. Consistent with prior work in group settings, significant decreases were found in general anxiety symptoms (Bullis et al., 2015; de Ornelas Maia et al., 2013; de Ornelas Maia et al., 2015). In addition to replicating these findings, the current study furthered the extant literature to also show significant decreases in the group setting in anxiety disorder-specific symptoms, including worry, social anxiety, and panic symptoms. Similar to the findings of Farchione et al. (2012) with individual treatment, effect sizes for symptoms of panic and worry were larger than those for social anxiety. This converging finding highlights variability in the types of anxiety symptoms that may be most responsive to the UP. The UP does not address several key components of cognitive models of SAD (e.g., focus of attention, negative self-image, etc.), and these may need to be more directly targeted to achieve further symptom relief in group-based treatment. The effect size for social anxiety was less than half of that found for depression. Given that 81% of participants met the clinical cutoff for social anxiety symptoms, the poorer outcome for social anxiety was not a result of this concern not being prevalent in the sample, or being addressed with exposures.
Depressive symptoms decreased during the treatment. Findings concerning improvements in depression symptoms have been mixed in the UP literature to date. For example, while Farchione et al. (2012) and de Ornelas Maia et al. (2013, 2015) reported decreases in depression symptoms, the initial pilot studies showed depression decreases on one of two measures, in Study 2 only, and neither Study 1 or 2 showed significant decreases in clinical severity of depression (Ellard et al., 2010). Bullis et al. (2015) reported significant decreases in depressive symptoms, but noted that the effect for depression was moderate, versus a very strong effect for anxiety symptoms. Decreases in anxiety symptoms with the UP may be more robust and consistent than decreases in depressive symptoms.
Depression is targeted to the same extent as other emotions in the UP, for example, with the focus on emotion-driven behaviors. However, given that participants in this study were treatment-seeking for anxiety, the majority of their situational emotion exposures would have been related to anxiety, as that was more specifically related to their treatment goals. The majority of the studies reviewed in this article included participants with a primary diagnosis of an anxiety disorder; as such, it may be that the smaller effect sizes for changes in depressive symptoms (in contrast to worry, panic, and general anxiety symptoms) are due to lower baseline levels of depressive symptoms. Indeed, in this study, baseline general anxiety symptoms were in the very severe range, and in contrast, baseline depressive symptoms were in the moderate range. In addition, with disorder-specific anxiety CBT, it is commonly reported that depression symptoms significantly decrease alongside anxiety symptoms, even though the depression was not directly targeted (e.g., Bauer, Wilansky-Traynor, & Rector, 2012). It remains uncertain whether the decreases in depression symptoms found in this study were a direct result of the UP itself, as opposed to a side effect of the anxiety symptoms (worry and panic in particular) decreasing.
Significant decreases were also found in negative affect, the proposed higher order factor underling anxiety, depressive, and related emotional disorders, lending credibility to the main target of this form of treatment. In addition, significant increases were observed in positive affect. Several studies have reported significant increases in positive affect with the UP (see Ellard et al., 2010, as an exception), suggesting that across various patient populations, the UP is successfully addressing both dimensions of affect.
The original UP pilot studies consisted of up to 18 individual 60-minute sessions (Ellard et al., 2010). The UP therapist manual suggests that the total treatment range from 11 to 17 sessions, with the interoceptive and situation-based emotion exposures taking 4 to 6 sessions (Barlow, Farchione, et al., 2011). In this study, we offered 14 sessions in group format, and given that the exposure module was moved up earlier, participants had three sessions directly devoted to this topic, but then also were encouraged to continue with exposures throughout the remainder of treatment as part of their homework assignment. Without formal direct comparison, it is not possible to make strong conclusions as to whether these modifications increased or decreased the effect sizes. Bullis et al. (2015) reported doing 12 sessions of group UP, with the modules done in order, and also found significant decreases in depressive and anxiety symptoms. As similar patterns of results were found in our study, this suggests that UP outcomes are robust despite changes in module order. Furthermore, well-controlled research with larger samples is needed to determine the optimal number of sessions devoted to each module, and to delineate any consequences of changing the order of the modules.
The current study is an effectiveness study, conducted in a naturalistic hospital setting. The participants were from a tertiary care facility, and the therapists were multidisciplinary and had varying levels of CBT and UP experience. Given this variability, staff were still able to facilitate significant clinical changes, which bodes well for administration and dissemination of the UP. This is particularly important given the multidisciplinary composition of most hospital settings, and the fact that many hospital settings may not have sufficient volume of patients with a given anxiety disorder diagnosis to be able to run homogeneous disorder-specific anxiety CBT groups.
Despite the many advantages of a transdiagnostic treatment, the UP does also present some disadvantages. Although the expectation is that all patients would complete all of the UP modules, not all modules may be significantly relevant to all emotional difficulties. For example, interoceptive exposure exercises were often perceived as irrelevant by participants who did not struggle with panic concerns and/or fear/discomfort related to bodily sensations. Although Boswell et al. (2013) reported that the UP led to preāpost treatment changes in AS, it would be of use for future research to use moderator analyses to determine whether interoceptive exposures included in the UP are relevant for individuals who are low on AS. While AS is transdiagnostic (e.g., Carleton, Sharpe, & Asmundson, 2007; Naragon-Gainey, 2010), some works show that different anxiety-related disorders are significantly higher on AS than others (e.g., Rector, Szacun-Shimizu, & Leybman, 2007; Taylor, Koch, McNally, & Crockett, 1992). Additional future research could address the modular nature of the UP itself, for example, if all modules are necessary, and the resulting treatment outcomes of each module administered independently. Dismantling studies could help inform which of the eight modules produce the largest clinical improvements.
A limitation of this study is that only three anxiety disorder presentations were included. Furthermore, work is needed to determine for which anxiety disorders the UP is most effective, and in what combinations. To date, for example, questions have been raised about the efficacy of transdiagnostic treatment with obsessive compulsive disorder (OCD) and posttraumatic stress disorder (PTSD) (Erickson, Janeck, & Tallman, 2009; Rector, Man, & Lerman, 2014). Furthermore, the present study did not include a control group, thus inferences about causality cannot be drawn. The sample size is small, although largely consistent with sample sizes for studies investigating the UP to date. Although clients were treatment-seeking at a specialized depressive and anxiety clinic, and scored at or above the clinical cutoff on at least two of the anxiety disorder-specific severity scales, structured diagnostic interviews were not included, so this study cannot speak to diagnostic specificity of treatment effects. Finally, this study did not include long-term follow-up after the treatment was completed, whereas other studies of the UP have included these, showing continued benefit post treatment (Bullis et al., 2014; Ellard et al., 2010; Farchione et al., 2012).
In conclusion, the UP may hold promise for a transdiagnostic group treatment of comorbid anxiety disorder symptoms. Group-based applications of the UP could be particularly efficient and parsimonious in hospital clinical settings with high demands for psychological treatment. There are challenges to group-based administration of the UP, and Bullis et al. (2015) reviewed guidelines that may be of use for those choosing to deliver the UP in group format. Although these preliminary results are encouraging, future research is needed to determine if the magnitude of change observed from a transdiagnostic treatment is comparable with the very well-established effects of anxiety disorder-specific CBT. Furthermore, research is needed to examine the impact of not addressing disorder-specific constructs supported by research as being of central importance in cognitive-behavioral models of anxiety disorders (e.g., intolerance of uncertainty, reassurance-seeking, focus of attention, etc.). Given the increasing demand for psychological services, future research is warranted to determine if offering treatment with the UP decreases wait times for treatment.
To date, no published studies have directly compared the UP with disorder-specific CBT protocols. Thus, it remains uncertain whether the UP produces at least equivalent, if not better, results than well-established disorder-specific CBT protocols for anxiety disorders, which have a wealth of research evidence (e.g., Norton & Price, 2007). In light of this, as suggested by Rector et al. (2014), transdiagnostic treatment approaches may at this point be best thought of as complementary, rather than contradictory, to empirically supported anxiety disorder-specific CBT. Furthermore, research directly comparing the two treatments is needed to determine whether the UP produces strong enough outcomes to warrant it replacing disorder-specific CBT for anxiety disorders.
Footnotes
Acknowledgements
The authors would like to thank the participants of the study, Jane Yating Ding and Nurit Postelnik for their assistance with data management, and Dr. David Grant for his editorial assistance. They would also thank the reviewers for their insightful commentary.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no external financial support for the research, authorship, and/or publication of this article.
